BIOPRO CLASS DESCRIPTIONS

Overview:
This two day course covers the breadth of the bioscience industry, from basic research to treatment and the ecosystem that supports it. The first day of this course introduces the bioscience/biotech industry, important terminology used in biological research and exciting developments in the field. The second day of the course focuses on how research is conducted, how research is translated to industry and how therapies are manufactured and approved for patient use. Additional topics include relevant topics in healthcare and bioscience policy. The Oregon bioscience industry (companies and research) will be highlighted throughout the course.

By the end of the course, participants will be able to:

• Understand the breadth of the bioscience industry
• Explain how therapeutics are conceived, manufactured and delivered
• Understand fundamental biology topics including basic molecular and cellular biology
• Use tools to learn more about relevant therapeutic areas
• Explain different types of research and the scientific process
• Explain how research is translated into industry including the startup ecosystem
• Understand the financial drivers of research, startups and industry
• Explain the regulated manufacturing process (clinical trial to approved therapeutic)
• Explain the clinical trial and basic FDA/EMA approval process
• Understand how treatments are delivered to patients and how treatments are paid for
• Explain important issues in bioscience policy
• Feel empowered to learn more!

Who Should Attend:
This course is geared for professionals or students looking to enter the bioscience industry, including managers, sales or service professionals, professionals from other industries, government officials, economic development professionals and more.

Prerequisites:
No prerequisites are necessary for this course.

Cost: Two-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Data integrity and good documentation practices (GDP) are essential in providing evidence of a safe and effective product. Learn what the key elements of good documentation practices and data integrity are, how to apply them, and how to proactively ensure your system is compliant.

By the end of the course, participants will be able to:

• Describe FDA Regulations for Good Documentation Practices (GDP)
• Perform GDP
• Describe FDA Guidance for Data Integrity
• Apply Data Integrity
• Apply Risk Management, Investigation, and CAPA to Data Integrity Concerns

Who Should Attend:
Anyone who works in a regulated industry

Prerequisites:
No prerequisites required. Overview of FDA Regulations and Quality Systems Overview or relevant experience are highly recommended.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
In this “hands on” course participants will design a product utilizing regulations for design control and application of risk management. Participants will learn how to perform risk management, plan design activities, determine design inputs and outputs, verification, validation, how to handle design changes, and the contents and maintenance of a Design History File.

By the end of the course, participants will be able to:

• Describe FDA Regulations for Design Controls
• Perform product risk management for design control
• Perform design planning
• Identify design input and outputs
• Perform a design review
• Identify design verification and validation
• Perform design transfer
• Perform design changes
• Maintain a Design History File

Who Should Attend:
Although Design Control is a regulation for medical devices, those who are involved with any part of product development in a regulated environment are encourage to attend. This can include purchasing, quality, regulatory, manufacturing, product development, as well as other functions.

Prerequisites:
No prerequisites required. Overview of FDA Regulations and Quality Systems Overview (or relevant experience) are highly recommended.

Cost: One-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
IEC 60601-1 is the Gold Standard for Medical Electrical Equipment and Systems when it comes to product safety (not just electrical safety).  The standard has been around since the 1970’s and is on it’s 3^rd edition (2005).  It is one of the most requested IEC standards. IEC 60601-1, 3^rd edition + Amendment 1(2012) is the most current revision. The medical device industry is constantly changing so is the IEC 60601 series of standards.  IEC 60601-1, 3^rd edition + Amendment 2 is already in process of being developed.

Come to this class and learn about the scope of IEC 60601-1, the additional Risk Management File requirements above & beyond ISO 14971, what is Essential Performance (not the same things as the EU MDD Essential Requirements or the EU MDR General Safety & Performance Requirements), why having an isolation diagram is critical for your design to meet the standard, determine a test plan for your product, are there other IEC 60601 series standards that apply to your product, and keeping up with new developments in the series & related standards.

Participants will also learn a basic tenet of the standard – 2 levels of protection is a critical concept to understand the standard.  Learn what national or international versions of IEC 60601-1 FDA, OSHA, Health Canada & the EU MDD are accepting (even if voluntary) and transition dates. Understand how the structure of series is important to understanding the requirements of each IEC 60601 standard in the series and learn what the general, collaterals and particular standards mean within the context of the IEC 60601 series of standards.

By the end of the course, participants will have gained:

• What the basic requirements of the standard are including Labeling & Marking, Testing and Constructional Requirements
• Understand some key concepts of the standard such as 2 levels of protection; Essential Performance, and Risk Management File requirements.
• What Standards in the Series may Apply to Your Device
• Understand the Steps to Take in Preparation for Product Safety Testing of Your Medical Electrical Equipment

Course Outline:

• Introduction to IEC 60601-1 Series of Standards & it’s Structure
• Scope of Standard
• Brief Historical Review
• Related Standards Important to the IEC 60601 series
• Future Changes to be Aware of & Transition Dates for National Versions of IEC 60601 for the US, Canada, & EU
• Constructional & Labeling Requirements
• What is an Isolation Diagram & why is it needed?
• Essential Performance & Risk Management File Concepts – Key Concepts (New to Ed. 3.X) for Edition 3.0 & 3.1
• Test Requirements
• Steps to Take in Preparation for Product Safety Testing of your Electrical Medical Device

Who Should Attend:
Anyone who is involved in any part of the design and development of medical electrical equipment! Specifically, managers, supervisors, and personnel in regulatory, engineering, design & development, quality or related disciplines.

Prerequisites:
No prerequisites. Bring something to take notes with.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
The home use market for medical devices has exploded over the last many years with the advent of smart phones, wearables, the Internet of Things, the “super-aging” of societies around the world, the ease of monitoring patients from their home, the portability of these devices, ease of use for the patient their caregivers and relatives, and the increasing costs of health care.

IEC 60601-1-11 is the Collateral Standard for medical electrical equipment and systems used in the home healthcare environment.  This standard is in its’ second edition and was last published in 2015. Come to this class and learn about the scope of IEC 60601-1-11 vs the US National Standard AAMI HA 60601-1-11:2015, US FDA definition in the Home Use FDA Guidance, the interrelation of IEC 60601-1-11 to IEC 60601-1, and what are the additional requirements of this standard IEC 60601-1-11 over IEC 60601-1.

By the end of the course, participants will have gained:

• What the basic requirements of the standard are including Labeling & Marking, Testing and Constructional Requirements
• Understand the difference in the US vs IEC definitions of the Home Use environment
• How the general standard IEC 60601-1 and IEC 60601-1-11 are intertwined

Course Outline:

• Scope of Standard of IEC 60601-1-11 vs AAMI HA 60601-1-11:2015 (US National Standard)
• FDA Home Use Guidance – how it’s Home Use definition is different from IEC 60601-1-11
• Current published IEC 60601-1-11 vs national & international versions of the IEC 60601-1-11 standard are being relied on for regulatory submissions for the US, Canada & EU.
• Interrelation of IEC 60601-1-11 to IEC 60601-1 & the Structure of the IEC 60601 Series
• Important Classification Changes relevant to IEC 60601-1-11 vs IEC 60601-1
• Marking & Labeling Requirements
• Constructional Requirements
• Test Requirements

Who Should Attend:
Anyone who is involved in any part of the design and development of home use medical electrical equipment! Specifically, managers, supervisors, and personnel in regulatory, engineering, design & development, quality or related disciplines.

Prerequisites:
“IEC 60601-1 – Medical Electrical Equipment – What You Need to Know” Oregon Bio course (or show instructor knowledge of IEC 60601-1, edition 3.1 prior to registering for this course). Bring something to take notes with.

Cost: half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
To successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This new course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process.

By the end of the course, participants will understand how to:

• Describe the goals of an internal audit
• State the benefits of internal auditing
• Determine the requirements of an internal audit
• Explain how ISO 13485:2016 differs from ISO 9001 and the areas of focus for Medical Devices.
• Plan an internal audit, and develop a guide list
• Perform an internal audit
• Identify nonconformity to requirements during an audit
• Report on an audit and follow up on corrective actions taken in response to audit findings
• Describe the actions necessary for maintaining a successful audit program

Who Should Attend:
People tasked with conducting Internal Audits of their organization’s ISO 13485:2016 Quality Management System.

Prerequisites:
There are no prerequisites to attend this training course but a basic understanding of the ISO 13485:2016 Quality Management System standard would be beneficial.

Cost: 2-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
The ISO 13485:2016 Standard continues to facilitate the global alignment of quality management systems with related regulatory requirements for the medical device supply chain. The revised Standard focuses greater attention on an organization’s ability to meet applicable customer and regulatory requirements, with an added emphasis on risk and change management. To effectively meet the requirements, top management must strategically apply risk based thinking and a process approach to the planning, monitoring and evaluation of the organization’s quality management system.

This briefing will familiarize managers with the intent and framework of the Standard, highlight the changes between the 2003 and 2016 versions of ISO 13485, and reference tools and techniques that will enable managers to address their responsibilities as well as support those involved in more detailed implementation efforts.

By the end of the course, participants will understand how to:

• Describe how the different sections of the ISO 13485 Standard work together within the framework of the Plan-Do-Check-Act cycle to enable effective operation of the quality management system.
• Explain how a process approach can help an organization meet customer and regulatory requirements more effectively and efficiently.
• Describe how risk-based thinking can be used at a strategic level to address both risks and opportunities.
• Identify the key changes between ISO 13485:2003 and ISO 13485:2016.
• Understand the requirements for top management and describe the objective evidence needed to demonstrate conformance.
• Recognize the implications of the revisions for the management of the organization’s quality management system.

Who Should Attend:
Management personnel in organizations that are either making the transition from ISO 13485:2003, or beginning the implementation to, ISO 13485:2016, and others involved in planning, implementing and maintaining a Quality Management System based on ISO 13485:2016.

Prerequisites:
The are no prerequisites for this training course.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
The FDA has more power to affect regulated companies than almost any other organization, yet many people don’t understand it. Many others ignore it as much as possible. But the FDA affects the job of every person in a medical device or drug company. This course is designed to provide participants with insight into what the regulations are, why they are there, where they fit together, when they apply, and how to interpret them. We will not just discuss Quality Systems and Good Manufacturing Practices, but also submissions, registration, clinical trials, recalls, and adverse event reporting. Each participant will develop a better understanding of the environment in which their company exists and how they can help their company thrive.

By the end of the course, participants will have gained:

• Familiarity with FDA concepts and organization
• An understanding of how their jobs are impacted by FDA regulation and how they can lessen the regulatory burden on their company
• Awareness of the most important regulations
• Ways to think about regulation constructively and creatively
• Information resources for further knowledge acquisition

Course Outline:

• FDA Organization and philosophy
• Overview of the types of regulations
• Medical device regulation throughout the product lifecycle
• Drug regulation throughout the product lifecycle
• How to approach regulations
• Navigation of the FDA website

Who Should Attend:
Anyone working in a medical device or drug company! Specifically, managers, supervisors, and personnel in manufacturing, engineering, quality assurance, or related disciplines.

Prerequisites:
No prerequisites.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Many organizations, such as FDA, ISO, OSHA, and EPA, can conduct audits or inspections in a biotech company. Most people view these events as scary, but there are ways to make them less difficult. The first method is compliance with the applicable rules. After that, preparation is the key. We will focus on these preparatory techniques, for example, using internal auditing as a tool, developing an inspection procedure, educating employees, and conducting mock inspections. Participants will roll-play being auditors and auditees.

By the end of the course, participants will have gained:

• Understanding of the role of an auditor
• Ways to prepare for an audit or inspection
• Method for conducting a mock inspection
• Tips on communicating with inspectors and auditors

Course Outline:

• Introduction to FDA inspections
• Introduction to ISO audits
• Overview of other regulatory inspections
• Compare and contrast
• Preparation tools and techniques
• Communicating with inspectors/auditors
• Resources

Who Should Attend:
Anyone working in a medical device or drug company! Specifically, managers, supervisors, and personnel in customer service, purchasing, engineering, manufacturing, quality assurance, or related disciplines.

Prerequisites:
No prerequisites.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Two key goals of a quality management system are to find the root causes of actual and/or potential problems and to develop permanent solutions. In this 1-day workshop you will learn how to use tools and methods of problem solving in order to develop and implement solutions that are accepted, efficient, and effective. This workshop will also examine best practice CAPA systems to provide thoughts and ideas on how to improve the performance of your current system. This workshop is perfect for the novice or for those desiring an invigorating refresher.

On completion of this training course you should be able to:

• Differentiate between corrective and preventive action
• Perform risk assessment effectively
• Identify and prioritize problems and create meaningful problem statements.
• Choose the problem solving method best suited to your situation
• Use tools to investigate true root causes of problems and to evaluate and prioritize solutions
• Use tools to evaluate feasibility and benefits of potential solutions.
• Develop successful implementation plans
• Evaluate effectiveness, suitability and adaptability of implemented solutions/corrective actions

Who Should Attend:
This course is for people tasked with maintaining and improving ISO 9001/AS9100/TS 16949/ISO 13485 Quality Management Systems and for making general improvements in their organizations performance.

Prerequisites:
No prerequisites.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
The new 2011 Process Validation guidance has formalized the phases and methods used in industry in the past to ensure that products used by the patient meet the regulations, specification, and will perform as intended. This course will present the principles presented in the guidance and regulations, how to design a Process Validation program, details on how to determine the Critical Process Parameters (CPP), and Critical Quality Attributes (CQA), the basics of performing a risk assessment, and reporting expectations. This course will also provide guidance on steps needed for changes after the process validation is complete and how process validation must be integrated into the quality systems.

The presenter will cover the key process validation concepts in the FDA and EU regulations, industry practices, and guidance documents (ISO 13485, ICH Q8, Q9, and Q10) along with those of PAT.

This session will include hands on sessions where the attendee will practice developing design and process flow documents and diagrams and performing risk analysis to the CQA’s and CPP’s. Attendees will have the chance to discuss, the application of practical approaches for satisfying lifecycle Process Validation expectations.

The attendee will take home hands on experience in developing a process validation program, including:

• Defining the process (Process flow diagrams)
• Determining the CQA’s and CPP’s
• Finalizing the criticality by performing a process failure modes effect analysis (PFMEA) which will confirm or change the CQA’s and CPP’s

Course Outline:

• Introduction and schedule
• Lecture: Principles on Process Validation including discussion of regulations
• Practice: Designing/defining a process and process flow diagram
• Lecture: Determining the Critical Process Parameters and Critical Quality Attributes; with a process risk assessment
• Practice: Determining the Critical Process Parameters and Critical Quality Attributes; with a process risk assessment
• Lecture: How to analyze and report the results of Process Validation

Who Should Attend:
Validation Engineers, Managers and Directors, Quality Managers, Directors, and Engineers; Product Development Coordinators, Managers, and Directors Manufacturing Supervisors, Managers, and Directors.

Prerequisites:
No prerequisites.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Quality Systems (QS) are sometimes viewed as a necessary evil or belonging only to production and QA personnel. However, effective QS can help a business not only comply, but excel. This course focuses on medical device companies and how to create, implement, and improve QS that match your company. Both FDA QS and ISO QS will be discussed. We will also cover: how different departments are impacted by QS, the biggest pitfalls in establishing and maintaining QS, and how to critically evaluate your QS. There will be group exercises and lots of interaction among participants to provide multiple options. In QS, it is definitely true that one size does not fit all!

By the end of the course, participants will have gained:

• Familiarity with QS concepts
• Techniques for organizing and managing QS
• Best practices for working in QS
• Methods for adapting your QS to be most effective

Course Outline:

• Introduction to FDA and ISO
• Lifecycles of QS
• Myths about QS
• Organizing principles
• Managing principles
• Questions to consider
• Resources

Who Should Attend:
This course is aimed at medical device personnel with some familiarity with QS. It will be beneficial to those with limited knowledge of QS, but we will NOT be going step by step through all the requirements of a quality system. Recommended for those in customer service, purchasing, manufacturing, engineering, quality assurance, or related disciplines.

Prerequisites:
No prerequisites.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Two key goals of a quality management system are to find the root causes of actual and/or potential problems in order to develop and implement permanent solutions that are accepted, efficient, and effective. This 1-day workshop will show how to use root cause analysis tools and methods to find the underlying causes of problems that impact an organizations operations and profitability. You will also learn the methodology to address corrective actions. This workshop is perfect for the novice or for those desiring an invigorating refresher.

On completion of this training course you should be able to:

• Prioritize root cause analysis and corrective actions based on risk
• Identify and prioritize problems and create meaningful problem statements
• Differentiate between remedial actions and root cause analysis
• Select and use tools to investigate true root causes of problems and to evaluate and prioritize solutions
• Understand the components of a good corrective action
• Write clear, complete, and effective corrective action requests
• Develop successful implementation plans
• Evaluate effectiveness, suitability and adaptability of implemented solutions/corrective actions

Who Should Attend:
This course is for people tasked with maintaining and improving ISO 9001/AS9100/TS 16949/ISO 13485 Quality Management Systems and for making general improvements in their organizations performance.

Prerequisites:
No prerequisites.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
The idea of change management is addressed throughout the cGMP regulations, such as when encountering issues and focusing on process improvements with the design of the manufacturing facility (§ 211.42), the design of the manufacturing equipment (§ 211.63), the design of the production and control procedures (§ 211.100), or the design of laboratory controls (§ 211.160). The current standards require that a risk-based approach utilizing scientific knowledge is used when implementing a change. The effect of the change should be evaluated, including any unintended, negative consequences. Evaluating the effects of a change can encompass additional tests or examinations of subsequent batches (e.g., additional in-process testing or additional stability studies), and is an important process in maintaining the validated state of the equipment and processes. Through interactive examples, this course will teach the process by which change management should be used to identify, evaluate, document, approve, implement, and close changes made throughout the product lifecycle.

By the end of the course, participants will be able to:

• Describe when change control should be applied.
• Discuss how to fully evaluate changes and their impact to maintaining a validated state and process.
• Create scientific and risk-based justifications and rationale for implementation of changes.
• Use best practices for implementation of changes and document completion of changes.
• Learn when and how to apply changes throughout the product lifecycle; with varying levels of formality applied based upon scientific and risk-based knowledge.

Course Outline:

• Regulatory requirements and expectations; link to ICH Q10
• The role of change control in maintenance of a validated state and process improvement
• Utilizing Quality Risk Management in the change management process
• Identification of changes
• Evaluation of change impact
• Documentation
• Like-for-like assessments

Who Should Attend:
Quality assurance, quality control, regulatory affairs, validation, manufacturing, technical support, IT, supply chain, and engineering professionals in the pharmaceutical, biopharmaceutical, or medical device industry.
All levels of management and service providers and vendors who serve pharmaceutical, biopharmaceutical or medical device industry clients

Prerequisites:
No prerequisites.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Building upon Overview of FDA and Quality Systems Overview courses, this course goes beyond the basics and uses interactive exercises to understand and apply current Good Manufacturing Practice (cGMP) regulations for pharmaceutical, biopharmaceutical and medical device industries. This course will dive into the details of 21 CFR Parts 210, 211, & 820, ICHQ7, and the EU GMP guidelines. Participants will benefit from real world examples and lessons learned to use risk-based and scientific principles to ensure product quality throughout the production lifecycle. This course will guide participants through the six system inspection model: Quality Systems, Materials, Packaging and Labeling, Production, Facilities & Equipment, and Laboratory Controls, to provide them with appropriate strategies for ensuring compliance.

By the end of the course, participants will be able to:

• Apply cGMPs to their specific job responsibilities beyond the basic elements.
• Establish and maintain a quality system that builds quality into the product and allows for implementation of continual improvement.
• Understand and interpret cGMPs in a practical manner to be able to apply the “right-sized” Quality Systems and GMPs to fit the specific environment, taking into account factors such as scope of operations, complexity of processes, and appropriate use of finite resources.
• Discuss specific requirements and strategies for compliance with 21 CFR Parts 210, 211, & 820, ICHQ7, and the EU GMP guidelines.
• Define each of the six-system elements: Quality Systems, Materials, Packaging and Labeling, Production, Facilities & Equipment, and Laboratory Controls

Course Outline:

• Quality Systems
  • Note: Other courses in the certificate program will provide greater detail in Quality Systems such as CAPA, Change Control, Deviation Management, and Quality Risk Management.
• Organization and Personnel
• Documentation (Records and Reports)
• Control of Materials
• Production Controls
• Facilities and Equipment
• Packaging and Labeling
• Laboratory Controls

Who Should Attend:
Quality assurance, quality control, regulatory affairs, validation, manufacturing, technical support, IT, supply chain, and engineering professionals in the pharmaceutical, biopharmaceutical, or medical device industry.
All levels of management who require a refresher course to stay current with GMP regulations and learn from case studies. Service providers and vendors who serve pharmaceutical, biopharmaceutical or medical device industry clients.

Prerequisites:
No prerequisites.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Today’s highly competitive environment leaves no time for trial and error.  Design of Experiments (DOE): Introduction provides a structured method for determining the relationship between factors affecting a process and the output of that process. With this information, you can quickly develop the optimum balance between factors leading to dramatic improvements in quality, cost, and productivity. Participants in this 16-hour course will gain a firm understanding of the statistical concepts and basic principles underlying Design of Experiments.

By the end of the course, participants will be able to:

• Explain the need for experimental design.
• Explain the terminology and principles of experimental design.
• Give examples of continuous and categorical factors.
• Give examples of interactive effects.
• Create design matrices for full factorial experiments.
• Analyze data from full factorial experiments and apply the results.

Who Should Attend:
Engineers, scientists, continuous improvement specialists, quality assurance personnel, or other technical professionals who are responsible for product, process, or test development, improvement, or control activities.

Prerequisites:
Participants should bring a laptop computer to this training class.  No prerequisites are necessary for this course, although previous exposure to basic statistical methods is helpful.

Cost: 2-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
This course provides a structured guide to the process of performing an effective Failure Mode and Effects Analysis for Design and Development (DFMEA). DFMEA can be performed during design and development on products to minimize risks and future costs of new products. It is also a highly effective technique to use in planning under any quality management system standard, such as ISO 9001 and ISO 13485.

By the end of the course, participants will be able to:

• Design and implement a process to perform Design Failure Mode and Effects Analysis
• Identify and select the appropriate participants for a FMEA Team
• Identify design failure modes and determine the relative ranking of failures using risk priority numbers
• Explain the different type of FMEA’s and be able to choose the appropriate type
• Develop a Design FMEA for your organization through hands-on activities and workshop exercises

Who Should Attend:
This course is for engineers, production managers, quality engineers and managers who are assigned to work on Failure Modes and Effects Analysis in Design and Development.

Prerequisites:
No prior knowledge is required to attend this course, but bringing an application to the class for a Design and Development Failure Modes and Effects Analysis would be beneficial.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
This course provides a structured guide to the process of performing an effective Failure Mode and Effects Analysis for Manufacturing Processes (PFMEA). PFMEA can be performed during development of manufacturing processes to minimize scrap and rework and to minimize the risk of quality “escapes”. It is also a highly effective technique to use in planning under any quality management system standard, such as ISO 9001 and ISO 13485.

By the end of the course, participants will be able to:

• Design and implement a process to perform Design Failure Mode and Effects Analysis
• Identify and select the appropriate participants for a FMEA Team
• Identify design failure modes and determine the relative ranking of failures using risk priority numbers
• Explain the different type of FMEA’s and be able to choose the appropriate type
• Develop a Design FMEA for your organization through hands-on activities and workshop exercises

Who Should Attend:
This course is for manufacturing and design engineers, production managers, and quality engineers/managers who are assigned to work on Failure Modes and Effects Analysis in Manufacturing Processes.

Prerequisites:
No prior knowledge is required to attend this course but bringing an application to the class for a Manufacturing Process Failure Modes and Effects Analysis would be beneficial.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Participants in this 16-day duration course will learn the theory and application of tools and methods for successful completion of improvement projects in a manufacturing business environment. Tools for the application of the Six Sigma DMAIC (Define-Measure-Analyze-Improve-Control) improvement strategy will be introduced with hands-on exercises and tutorials to ensure rapid learning and knowledge retention.  The training style is tell-show-do, with a strong emphasis on individual hands-on exercises and team-based activities. Training workbooks are comprehensive, self-contained, and serve as excellent references for learning and review. Classroom training sessions are interspersed with periods of work on actual company-supported improvement projects.

By the end of the course, participants will be able to:

• Deliver a financial return to their organization through completion of a Six Sigma Green Belt improvement project
• Apply benefit-feasibility analysis to identify improvement projects aligned with your organization’s priorities for quality, delivery, customer satisfaction, and profitability.
• Successfully apply appropriate Six Sigma Green/Black Belt tools to future projects
• Perform basic statistical analyses using Excel.
• Develop, evaluate, and implement improvements that can dramatically reduce scrap, rework, complexity, defects, delays, and other forms of waste in manufacturing and transactional processes.
• Translate Six Sigma analyses into recommendations for improving your work place processes
• Apply statistical and/or non-statistical control tools to sustain the gains from project improvements

Who Should Attend:
This course is designed for Engineers, Quality Analysts, Process Improvement Specialists, Program Managers, Project Leaders, and others who want to learn the Six Sigma Green Belt methodology and apply it to make breakthrough improvements in performance within their workplace.

Prerequisites:
Trainees should have team leadership, experience with process improvement, and knowledge of Excel to learn new things quickly. They should also have prior experience with statistical methods and a working knowledge of high school algebra.

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Combining Lean and Six Sigma into a single improvement initiative eliminates redundant infrastructure and provides the ultimate in world-class performance: Six Sigma quality combined with Lean speed! This 2-day module will get you up to speed on Lean Six Sigma principles and methods.

By the end of the course, participants will learn:

• How integrating Lean and Six Sigma can dramatically improve your business results
• How the DMAIC (Define-Measure-Analyze-Improve-Control) project roadmap can improve LSS project results, including greater reductions in lead time and cost of waste
• How to identify and prioritize LSS projects for maximum impact
• How to deploy Lean Six Sigma projects
• How to charter LSS projects
• Create accurate current state process maps
• How to select and launch teams for effectiveness
• Understand leadership responsibilities

Tools participants will learn:

• DMAIC project roadmap
• Identifying and prioritizing improvement projects
• Improvement project reporting
• Chartering improvement projects
• Process mapping

Who Should Attend:
This course is designed for Engineers, Quality Analysts, Process Improvement Specialists, Program Managers, Project Leaders, and others who want to learn the Six Sigma Green Belt methodology and apply it to make breakthrough improvements in performance within their workplace.

Prerequisites:
Trainees should have team leadership, experience with process improvement, and knowledge of Excel to learn new things quickly. They should also have prior experience with statistical methods and a working knowledge of high school algebra.

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Reliable data is required for Lean Six Sigma Improvement projects. This 2-day module explains how to collect data to quantify the current state and establish desired improvement goals. LSS-101: Introduction to Lean Six Sigma must be taken before LSS-102: Measuring Process Performance-I.

By the end of the course, participants will learn how to:

• Conduct process walks, apply good interviewing and listening techniques, and identify “low hanging fruit” opportunities for improvement
• Create accurate value stream maps
• Recognize basic data types: quantitative and categorical
• Identify X and Y variables for your LSS project
• Perform sample size calculations for data collection
• Collect data that is representative of the current state
• Calculate project benefit metrics based on quantitative and categorical data

Tools participants will learn:

• Observing the current state
• Value stream mapping
• Sample size calculation
• Basic statistics and normal distribution

Who Should Attend:
This course is designed for Engineers, Quality Analysts, Process Improvement Specialists, Program Managers, Project Leaders, and others who want to learn the Six Sigma Green Belt methodology and apply it to make breakthrough improvements in performance within their workplace.

Prerequisites:
LSS-101: Introduction to Lean Six Sigma

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Reliable data is required for Lean Six Sigma Improvement projects. This 2-day module explains how to collect data to quantify the current state and establish desired improvement goals. LSS-102: Measuring Process Performance-I must be taken before LSS-103: Measuring Process Performance-II.

By the end of the course, participants will learn how to:

• Conduct measurement system analyses
• Apply Pareto analysis to categories of defects, errors, failures, cost, non-value adding time, or other types of waste
• Calculate and interpret process capability indices

Tools participants will learn:

• Measurement system analysis
• Statistical graphics
• Pareto analysis
• Process capability indices

Who Should Attend:
This course is designed for Engineers, Quality Analysts, Process Improvement Specialists, Program Managers, Project Leaders, and others who want to learn the Six Sigma Green Belt methodology and apply it to make breakthrough improvements in performance within their workplace.

Prerequisites:
LSS-102: Measuring Process Performance-I

Location: Location and driving directions will be emailed separately upon registration.

Overview:
One of the most important and challenging steps in a Lean Six Sigma improvement project is to determine the root cause(s) of problems within the project scope. Possible causes must be confirmed or debunked by data analysis. If there are multiple root causes, these should be prioritized. Once root causes have been identified, the next step is to develop and prioritize solutions. The best solution(s) are identified, tested, and then assessed to make sure that the intended outcome is achieved. The root cause analysis and process improvement is presented in this 2-day module. LSS-103: Measuring Process Performance-II must be taken before LSS-104: Root Cause Analysis and Improving the Process.

By the end of the course, participants will learn how to:

• Describe the population associated with a process
• Classify significance testing into two basic types: comparing populations, correlating variables
• Explain P values and how they relate to standards of evidence
• Test for differences between or among population
• Test for correlations between variables and interpret the results
• Perform root cause analysis
• Use common solution categories to assist in developing solutions for your project
• Use the results of root cause analysis to develop solutions for your project
• Apply Lean solutions
• Use benefit/feasibility analysis to evaluate proposed solutions
• Apply FMEA to your proposed future state
• Plan and conduct a pilot study of your future state process
• Establish statistical baselines for your future state process
• Test for significant improvements of the future state over the current state

Tools participants will learn:

• Significance testing
• Interpreting P values
• Five whys
• Affinity analysis
• Fishbone diagram
• Developing solutions
• Lean solutions
• Theory of Constraints
• Failure Modes & Effects Analysis (FMEA)

Who Should Attend:
This course is designed for Engineers, Quality Analysts, Process Improvement Specialists, Program Managers, Project Leaders, and others who want to learn the Six Sigma Green Belt methodology and apply it to make breakthrough improvements in performance within their workplace.

Prerequisites:
LSS-103: Measuring Process Performance-II

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Developing and implementing a control plan is necessary to sustain the gains achieved by the project. This 2-day module will conclude with a test for successful completion of the Lean Six Sigma series. LSS-104: Root Cause Analysis and Improving the Process must be taken before LSS-105: Sustaining Improvement Efforts.

By the end of the course, participants will learn how to:

• Develop a control plan for the future state
• Explain the difference between common causes and assignable causes
• Calculate control limits for some commonly used control charts
• Explain the purpose and nature of a response plan
• Describe a scenario where a process outcome fails to meet a customer expectation, but it is not appropriate to initiate a response plan
• Understand the principle of a visual factory

Tools participants will learn:

• Control Plan
• Statistical Process Control (SPC)
• Response Plan

Who Should Attend:
This course is designed for Engineers, Quality Analysts, Process Improvement Specialists, Program Managers, Project Leaders, and others who want to learn the Six Sigma Green Belt methodology and apply it to make breakthrough improvements in performance within their workplace.

Prerequisites:
LSS-104: Root Cause Analysis and Improving the Process

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Participants in this course will learn the fundamental Lean Six Sigma philosophy and how to apply the tools and methods in their work place on a daily basis. Participants will learn how to identify improvement opportunities and be a valuable resource within Lean Six Sigma project teams led by Green Belts and Black Belts.

By the end of the course, participants will be able to:

• Use Lean Six Sigma terms and concepts to communicate with others with an emphasis on voice of the customer, critical to quality, speed and non-value-added
• Explain each phase of the Lean Six Sigma Define, Measure, Analyze, Improve and Control (DMAIC) methodology.
• Map a process, understand inputs and outputs and that every organization is a collection of processes.
• Explain the role of the Yellow Belt in the context of all other Six Sigma roles (Black Belt, Green Belt, Champion, etc.)
• Understand the organization’s improvement project pipeline strategy – selection process, prioritization and tollgate process
• Learn the Six Sigma tools most widely used in manufacturing applications:
  • Define Tools – Metrics, structured brainstorming, SIPOC, process mapping, I/O analysis
  • Measure Tools – Cause-and-effect matrix, FMEA, data collection, cost of poor quality
  • Analyze Tools – Pareto charts
  • Improve and – Solution Design Matrix
  • Control Tools – Control Charts

Who Should Attend:
This course is for people who want to learn the fundamentals of the Lean Six Sigma methodology and the basic tools.

Prerequisites:
There are no prerequisites for this training class

Cost: 2-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Any departure from an approved instruction or established standard used in the manufacturing process, including data or results outside of the expected range, is considered a deviation and must be investigated and evaluated for impact to product quality. Other terms are used for deviations in regulations and guidance, including “non-conformances” and “discrepancies”. Whichever terminology is used, deviations are a normal part of any manufacturing process, but how they are handled is a matter defined in the law as per 21CFR211.100, 211.111, and 211.160 and various other EU GMP guidelines. Participants in this course will use real world examples to learn the process of identifying, documenting, and evaluating deviations.

Note: Corrective and Preventive Actions (CAPA) is addressed in a separate course.

By the end of the course, participants will be able to:

• Define deviation (or non-conformance) and know when and how to identify when they occur.
• Use best practices for documenting deviation occurrence in a clear, concise, and timely manner.
• Discuss the importance of investigating and justifying deviations.
• Evaluate deviations based upon their impact and assign appropriate investigation activities commensurate with the level of risk.
• Monitor for and identify deviation trends and implement appropriate corrective actions.
• Learn when and how to apply deviation management throughout the product lifecycle; with varying levels of formality applied based upon scientific and risk-based knowledge.

Who Should Attend:
Quality assurance, quality control, regulatory affairs, validation, manufacturing, technical support, IT, supply chain, and engineering professionals in the pharmaceutical, biopharmaceutical, or medical device industry.
All levels of management and service providers and vendors who serve pharmaceutical, biopharmaceutical or medical device industry clients.

Prerequisites:
No prerequisites.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
This 16-hour course provides an introduction to analyzing common business and industrial data.

By the end of the course, participants will be able to:

• Analyze data using the most appropriate statistical methods and interpret the results.
• Use statistical graphics to display data and the results of data analysis.
• Distinguish between comparison and correlation hypotheses.
• Apply the most appropriate statistical methods to test comparison and correlation hypotheses.
• Use a leading PC-based statistical software program.

Who Should Attend:
Engineers, scientists, technicians, supervisors, business analysts, and other personnel in engineering, manufacturing, quality assurance, and related disciplines who are responsible for data-based decision-making in the industrial workplace.

Prerequisites:
A laptop computer is required for this course. No other prerequisites are necessary for course participation except for a good understanding of Windows-based PC software.

Cost: 2-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
This one-day highly interactive course provides an overview of the principles of Lean Manufacturing. Participants review the history of lean manufacturing and learn how lean manufacturing tools and programs apply in today’s manufacturing environment.  The course combines lecture and simulation that affords participants an immediate opportunity to apply the principles learned in the class.  The results of the first simulation round provide the setting for continuous improvement.  Lean principles incorporated over subsequent rounds allow participants to transform a chaotic, inefficient process to a highly productive and efficient production process.

By the end of the course, participants will be able to:

• Identify the “nine wastes”
• Demonstrate knowledge of the difference between “value-added” and “non-value-added” activities
• Apply Lean implementation tools in a simulation situation and describe how/why they are used
• Explain and define how Lean Manufacturing can impact the success of an organization

Course Outline:

• Lean Fundamentals
• Definition and philosophy
• Value-Added vs. Non-Value-Added
• Producing to demand
• The Nine Wastes
• The traditional 8 wastes plus newly-added environmental waste
• Lean tools
• Various Lean tools (e.g. 5S, Batch Reduction, POUS, Quality at the Source)
• Apply tools during simulation rounds throughout the day
• Designing work flow
• Line balancing
• takt time
• Bottom-line impacts of Lean
• Guidelines for Successful Implementation

Who Should Attend:
Production managers, supervisors, engineers, continuous improvement specialists, quality assurance personnel, front-line employees, or others who are responsible for production or processes.

Prerequisites:
Experience with manufacturing and quality processes in a manufacturing environment.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
This program provides a structured approach and a set of skills to help people involved in improving organizational performance to define, prioritize, map, and improve business processes.

Using interactive exercises, participants follow a practical, step-by-step approach that focuses on clearly defining processes through the use of “process maps”. The maps provide a foundation for documenting business processes; a key requirement for making effective improvements.

By the end of the course, participants will be able to:

• Explain the benefits of process mapping.
• Explain how process mapping fits with process management and continuous improvement initiatives.
• Categorize and prioritize processes for mapping.
• Describe how process maps can be used in a documented quality system.
• Use the SIPOC model for process definition prior to mapping.
• Follow a step-by-step method to create useful process maps.
• Apply flow charting techniques at different levels: system, sub-system, process, and task.
• Recognize a variety of flowchart types and select the appropriate format.
• Analyze flowcharts for streamlining and improvement opportunities.

Who Should Attend:
This course is for people needing to know how to map a business process.

Prerequisites:
No prerequisites.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
The International Conference on Harmonisation (ICH) was established in 1990 with the goal of achieving greater synchronization in the interpretation and application of regulatory requirements of Europe, Japan and the United States for pharmaceutical product registration. ICH Guidance documents Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) work in conjunction with one another to describe a science- and risk-based approach to pharmaceutical manufacturing and development. Quality Risk Management (QRM) is the glue that holds the pieces together, and with the implementation of ICH Q9, it has become a regulatory expectation to provide a risk-based framework for the entire quality system from development to commercial production and continual process improvement. This course will explain the relationship between ICH Q8, Q9, and Q10, and use interactive breakout sessions to describe regulatory expectations for risk-based management and programs.

By the end of the course, participants will be able to:

• Describe in detail the content of ICH Q8, Q9, and Q10 guidance documents.
• Explain the relationship between the guidance documents, and how they are used holistically throughout the product lifecycle.
• Apply risk management methodologies throughout the product lifecycle and quality system.

Course Outline:

• ICH Q8
  • Quality by Design (QbD) principles
  • Critical Quality Attributes (CQAs)
  • Design space
  • Control strategy
• ICH Q9
  • Quality Risk Management (QRM) principles
  • Risk assessment and methodologiese
  • Risk control
• ICH Q10
  • Pharmaceutical quality system principles
  • Relationship to GMPs
  • Continual improvement of product quality and quality system
• How ICH Q8, Q9, and Q10 work together

Who Should Attend:
Quality assurance, quality control, regulatory affairs, validation, manufacturing, technical support, IT, supply chain, and engineering professionals in the pharmaceutical, biopharmaceutical, or medical device industry.
All levels of management and service providers and vendors who serve pharmaceutical, biopharmaceutical or medical device industry clients.

Prerequisites:
No prerequisites.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
The key to improving process performance is the ability to understand, control and reduce variation. In this workshop, participants will learn how the monitoring and analysis tools of SPC can be used to achieve that goal. Going beyond the mere mechanics of SPC, this workshop will also guide participants through the steps needed to define a process and determine proper measurement techniques so that the right control chart is used in the right place at the right time.

By the end of the course, participants will be able to:

• Understand the role of SPC in the quality improvement process
• Identify key process and product characteristics
• Establish key characteristics for process monitoring
• Distinguish between variable and attribute data
• Create a meaningful data collection plan
• Use statistics to separate common and assignable causes of variation b
• Decide when a particular SPC tool is appropriate to use
• Collect data for that tool and convert the data into charts
• Interpret patterns and signals on the charts
• Perform a process capability study
• Use Cause and Effect diagrams and Pareto charts to diagnose process problems
• Use statistical software programs for data analysis and to produce informative statistical graphics

Course Outline:

Day 1

• Why Use SPC?
• Defining the Process
• Measuring the Process
• Using Statistics

Day 2

• Control Charts for Variables
• Control Charts for Attributes
• Identifying Patterns and Trends
• Determining Process Capability
• Diagnosing the Process

Who Should Attend:
Individuals and teams requiring a thorough understanding of the philosophy and tools of Statistical Process Control (SPC) in order to plan and implement successful SPC efforts their workplace.

Prerequisites:
Participants in this training course should have:

• A laptop computer loaded with MS Excel (version 2003 or later). They will also need to add in the Analysis ToolPak, a statistical package that comes with MS Excel.
• An SPC project in mind from their workplace.
• Experience using personal computers, especially using the Windows operating system. Basic math skills and be able to follow the order of operations for basic algebraic functions.

Cost: 2-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
A value stream is all activities required to design, create and deliver a product or service to a customer. A Value Stream Map is a tool that helps you visualize the flow of material and information through a value stream. It is a critical first step in lean transformations, as it shows you where to apply lean tools and methods for maximum effect. It also helps you avoid the common mistake of “cherry-picking” individual lean tools that create “islands” of improvement with limited benefits. Participants in this “hands-on” workshop learn how to create and apply Value Stream Maps for the production flow from raw material through to the customer. They will learn how to see value, differentiate value from waste, and eliminate the sources of waste by creating accurate current-state maps and leaner future-state maps for a product family.

By the end of the course, participants will be able to:

• Explain to others the benefits of Value-Stream Mapping (VSM)
• Understand major Lean concepts and identify value-added and non-value-added activities
• Draw a current-state value-stream map for a product family
• Design and draw a future-state map showing leaner door-to-door material and information flow
• Target kaizen activities for bigger, more sustainable impact
• Develop a direction and plan for implementing the desired future state

Who Should Attend:
This workshop is for operators, engineers, managers, supervisors, technical support personnel, and change agents from any organization at any point in their lean journey.

Prerequisites:
There are no prerequisites for this training course.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
This workshop guarantees to increase project success by improving leadership, planning, estimating, collaboration, and communication competencies. The powerful results from this course are based on the instructor’s direct experience on engineering projects and experience.

Case studies, real-life examples and exercises are used extensively to illustrate how the principles apply on the job. The case studies are drawn from a broad range of product development team environments at small, medium, and large companies serving many industries.

By the end of the course, participants will be able to:

• Effectively lead engineering projects and teams
• Increase the level of buy-in and commitment to project schedules
• Develop key interpersonal and business competencies
• Use matrixed management effectively
• Improve the accuracy of project estimates
• Assess the effectiveness of project lifecycle models used at work
• Improve project-related communication
• Become more influential
• Identify leadership development goals specific to individual needs

Course Outline:

Day 1

• Overview of Essential Skills
  • Balancing technical and non-technical skill development. The importance of “soft” skills
• Developing Interpersonal Competencies
  • Conversation tips
  • Deciding which technology to use for communication
  • The art of listening
  • Teamwork
  • Building rapport with business associates, helping others to see your view
  • Integrating your ideas with surrounding influences and business objectives
• Presentations Tips
  • Presenting to groups, both small and large
  • Length and detail of presentations
  • Tips for using PowerPoint or other visual aids
• Customer Service
  • Satisfying the needs of both internal and external customers
  • Commitment: the ultimate customer service tool
• Managing Many Priorities
  • The challenges inherent in several top priorities
  • Separating real priorities from everyday fire drills
  • Organizing skills: Eliminating your time-wasters
• Project Planning Overview
  • Project planning competencies and tasks
  • Integrating a high level of commitment into plans
• Project Planning Details
  • Project lifecycle, pros and cons of standard lifecycle models
  • Examples of good planning and poor planning
  • Dealing with ambiguity and uncertain resource availability

Day 2

• Project Leadership and Project Management
  • Overview of necessary leadership competencies
  • Opportunities to distribute project leadership and management responsibilities
  • Case study: Sharing of Project Leadership and Management Responsibilities
• Project Estimating
  • Estimation challenges, prerequisites for estimation
  • Comparison of estimation methods
  • Estimation steps
• Scheduling Practices
  • Work Breakdown Structure (WBS)
    • Scheduling tools, Gantt and PERT charts
    • Commitment based scheduling, cost of delay
• Detailed Design Plans
  • Planning steps, defining roles and responsibilities
  • “Success” criteria
  • Balancing planning with prototyping
• Design Review Practices
  • Critical design reviews and milestones
  • Formal and informal design reviews
  • Preparation for reviews and accountability
  • Making tough decisions related to design review findings
  • Engaging experts from outside the team
• What is Leadership?
  • What leadership is, and what leadership is not
  • Why leadership skills are important for engineers and technical professionals

Who Should Attend:
Electronics and Electrical Engineers, Software Engineers and Developers, Mechanical Engineers, Structural Engineers, Project Leaders, Engineering Supervisors

Prerequisites:
No prerequisites.

Cost: 2-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
This two-day intensive workshop is specially developed to provide a solid foundation in financial analysis and decision-making, both from the perspective of the company and specific projects.

Financial Skills for Non-Finance People is an interactive workshop format including exercise, case studies, and real world projects to improve participants understanding and application of:

• Financial analysis tools and how to apply them to value new products and programs
• Basic and advanced techniques to make tradeoff and a portfolio decisions for product investments
• Financial techniques to communicate and sell advanced R&D, platform and architecture programs

By the end of the course, participants will have gained:

• An understating of how development programs impact key numbers valued by executives
• Key financial skills to justify product or technology programs
• A firm grasp of the three major financial reports: Income statement, balance sheet and statement of cash flows
• How to determine the ROI of platform and advanced R&D projects
• A working knowledge of risk and overall value of your product portfolio

Who Should Attend:
Product managers and marketers, engineering managers and leads.

Prerequisites:
Each student is required to bring a laptop loaded with MS Excel software.

Cost: 2-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
The ability to perform effectively in teams has become a basic expectation for members of high performance organizations. This workshop provides participants with an understanding of when to use a team, what constitutes an effective team and what their role should be as a member. Participants will learn and practice the interpersonal communication and team process skills that foster the highest creativity and most productive behaviors.

By the end of the course, participants will be able to:

• Determine whether a team is needed.
• Identify the three broad goals a team may pursue, and recognize the dominant features and member selection criteria for each goal type.
• Define the difference between a group and a team.
• Identify characteristics of successful teams.
• Recognize the stages of team development and their importance to team performance.
• Recognize and work through common issues that hinder team performance.
• Define and know how to reach a consensus decision.
• Apply five methods for getting teams “unstuck.”
• Define team member roles and responsibilities.
• Improve communication through effective listening skills and feedback.
• Evaluate team performance/progress using a simple survey.

Who Should Attend:
This workshop is for people working in teams

Prerequisites:
(Recommended) Business Communication Fundamentals

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Effective team leadership is a prerequisite for success in today’s high performance organizations. In this workshop, participants will learn how to successfully launch and lead teams. A strong emphasis is placed on learning and practicing the skills necessary to facilitate team development and manage change to achieve optimal performance and more creative solutions.

By the end of the course, participants will be able to:

• Identify the elements necessary for a team to be successful.
• Distinguish the stages in a team’s life cycle and address the associated task, leadership and group issues.
• Use the diversity of members to improve team performance.
• Employ strategies for resolving conflicts and getting teams “unstuck.”
• Identify the leadership characteristics that enable appropriate use of power and influence to motivate teams.
• Recognize the role of change in organizations.
• Apply strategies to cope with change.
• Apply tools for planning and managing change efforts.
• Help both the organization and individuals work through roadblocks to solutions

Who Should Attend:
This workshop is for people responsible for launching and leading teams

Prerequisites:
High Performance Teamwork (bring your workbook from this course)

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration

Overview:
Few leaders have the luxury of focusing on a single project. Instead, they must balance multiple simultaneous projects, constantly making imperfect trade-offs between conflicting needs. This class looks at the personal skills you need to manage multiple projects. However, there is only so much you can do on your own. Therefore, this class also looks at the supporting organizational framework that enables a project-based organization to do many projects. It also includes a short introduction to portfolio management, which is a technique for deciding which projects to invest in.

By the end of the course, participants will be able to:

• Explain how portfolios, programs, and collections of loosely related projects are different.
• Understand the crucial impacts that organizational considerations such as governance, stage gates, and matrix responsibilities have on managing multiple projects.
• Plan projects in a multiple project environment, including setting priorities, sharing resources, and coordinating dependencies across projects.
• Use a dashboard to track and steer the execution of a collection of projects
• Escalate and resolve cross-project issues.
• Select appropriate techniques to conquer the size and complexity of programs containing multiple projects.
• Explain how to construct an integrated portfolio of projects that is aligned with strategy, is balanced, and is feasible.
• Create an action plan to apply the class materials to their unique work situation.

Course Outline:

• Personal Productivity Techniques
• Good Organizational Support
  • Working Across a Matrix
  • Power and Influence
  • Organizational Maturity
  • Standard Methodologies
  • Project Governance
  • Management Support
• Being Effective on Every Project
  • Good Project Hygiene
  • Consistency and Repeatability
  • Firefighting
• Inter-Project Dependencies
• Planning Resources Across Projects
• Executing Multiple Projects
  • Tracking
  • Escalation, Prioritizing, and Issue Resolution
  • Multitasking
  • Leveraging Lessons Learned
• Introduction to Programs and Portfolios
• Action Planning

Who Should Attend:
All previous Project Management: Foundations and Best Practices attendees. This class is designed for experienced product, project, and line managers who want to improve personal and organizational capabilities for managing multiple simultaneous projects. This is not a class on personal “juggling” skills.

Prerequisites:
Attendees should have prior experience applying project management techniques and methodologies on stand-alone projects.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
This course introduces students to the foundations of successful project management, especially in a technology environment. Students will learn key project management concepts, then immediately apply them in a hands-on team simulation. This course approaches project management from the standpoint of managing a single, stand-alone project that is small to medium in size. It takes students through the project life cycle in the same sequence they would face when managing a real project in the workplace.

By the end of this class, you will understand how to manage a project from beginning to successful completion.

By the end of the course, participants will be able to:

• Explain the role and value of project management.
• Recognize common causes of project success and failure.
• Balance competing priorities.
• Identify individual and team skills that affect the success of a project.
• Initiate a project using chartering and a project kickoff.
• Set stakeholder expectations early.
• Identify deliverables and requirements, and create plans for managing them.
• Perform the activities needed for a successful project planning phase.
• Break down deliverables into tasks and activities using a Work Breakdown Structure (WBS).
• Identify dependencies between tasks and estimate the effort required to complete the tasks.
• Develop a schedule, resource plan, and budget that fit the project.
• Identify and manage risks.
• Plan for communication, quality, scope changes and procurement.
• Monitor project progress, steer a project during execution, and take corrective action.
• Increase team motivation and performance.
• Close out a project with requirements verification, acceptance and handoff.
• Complete a lessons learned review.

Who Should Attend:
Engineers, scientists, clinicians, researchers, administrators, continuous improvement specialists, quality assurance personnel, or other technical professionals who are responsible for product, process, or test development, improvement who must organize and manage small to medium-sized projects.

Prerequisites:
Previous experience in a project environment is helpful, but not required.

Cost: 2-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Managing risk is essential to project success. The occurrence of rework, errors, and injury can be reduced or eliminated when risk is identified, controlled, and responded to on a project. Risk assessment and management is a proactive way to improve the delivery of cost, schedule, and performance on your projects. In fact, studies conducted by the Project Management Institute (PMI) quote a 90% decrease in project problems when risk management is used. Through risk management, the project manager gains control of the project, rather than having the project control the project manager. Through exercises and class discussions, this workshop allows participants to practice key roles in the risk management process for projects. The focus of this seminar is to provide simple, practical approaches and techniques for managing risk – taking the complex and making it simple.

By the end of the course, participants will be able to:

• Use templates and techniques for identifying and evaluating risk
• Determine people’s profile for risk in your company or department
• Manage risk in project phases
• Assess impact and probability of risk
• Identify ways to avoid, mitigate, transfer, or accept risk
• Create contingency plans
• Determine responses to identified risks

Course Outline:

• Introduction
• Context/Framework
  • Risk Definitions
  • Obstacle Identification
  • Risk Management Cycle
  • Risk in Project Phases
• Planning Kick-Off
  • Kick-Off Meeting
  • Project Plan – Scope
  • Work Breakdown Structure
• Risk Planning
  • Risk Management Scalability
  • Gathering Documents
  • Risk Tolerances
  • Assessing Risk Tolerances
  • Risk Management Plan
• Risk Identification
  • Risk Factors
  • Authority
  • Risk Identification Tools and Techniques
  • Risk Identification Outputs
  • Categories of Risk
  • Project Warning Signs
  • Managing Risk with Assumptions
  • Assumptions Schedule – Example
• Risk Response Planning
  • Risk Avoidance
  • Risk Transference
  • Risk Mitigation
  • Risk Acceptance
  • Contingency Plan
  • Assumptions
  • Risk Response Planning
  • Scheduling Tips
  • Contingency Plans
  • Building a Risk Management Plan
  • Risk Table
  • Rating Impact and Probability
  • Risk Scoring
• Risk Monitoring and Control
  • Risk Reviews
  • Results of Risk Monitoring and Control
  • Managing Risk with Assumptions
  • Assumptions Schedule – Example
• Seminar Close
  • Next Steps for Managing Risk
  • Administration
  • Learning Objectives
  • Appendix: Stakeholder Analysis Form
  • Appendix: Risk Assessment Template
  • Appendix: Risk Table – Full Form
  • Appendix: Bibliography/Suggested Reading

Who Should Attend:
All former Project Management Training participants, Project Managers, Program Managers, Senior Team Members, Engineers, Scientist, Technical Leaders, and Functional Managers.

Prerequisites:
Previous formal project management from any institution (private or public), and/or experience in a project environment.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
While your technical skills (hard skills) may get your foot in the door, it’s your soft skills that are crucial for success and longevity with the organization. Whether communicating with your co-workers, your boss, or upper level management; get your message heard in a clear, concise and compelling manner. In this interactive business communication course, you will sharpen your verbal, non-verbal and written tools to help you communicate more effectively, and promote a respectful working environment.

We will examine:

• Foundation of communication
• How to write effective and persuasive emails
• Active listening skills
• Techniques to work through stress
• Your nonverbal tool kit

How You Will Benefit:

• Improve personal credibility
• Create interest and action for your ideas
• Hone your ability to successfully do your job, while working harmoniously with others

Course Outline:

• Modes of communication
  • Verbal
  • Nonverbal
  • Written
• Phone etiquette
• Email best practices
• Listening skills
• Communicating when upset
• Stress management techniques

Who Should Attend:
Anyone in an organizational environment that must communicate ideas, processes or products.

Prerequisites:
No prerequisites.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Every organization, team and individual experiences conflict in business. If not addressed properly, conflict can turn into personal dislike and team breakdown, often creating an unproductive and uncongenial work environment. However, if conflict is addressed properly, the outcome can be advantageous for all parties involved by expanding self-awareness, sparking creativity, encouraging team cohesiveness, and increasing productivity.

We will examine:

• Causes of conflict in business
• Communication perspectives
• Styles of conflict management
• 5 step process for conflict resolution

How you will benefit:

• Promote a respectful work environment by practicing preventative communication
• Leverage conflict behavioral styles for a quicker consensus and decision making
• Managing individual conflict styles will result in team cohesiveness and increased productivity

Course Outline:

• Identification and causes of conflict
  • Work environment
  • Personality
  • Activity
• Response to Conflict
  • Conflict behavioral styles-individuals’ approach to conflict
• Consequences of Response to Conflict
  • Stress
  • Managing Stress
• Building Trust
  • Activity
• Introduction to 5 Step Conflict Resolution Process

Who Should Attend:
Individuals and work teams that strive for a respectful and productive work environment

Prerequisites:
Highly recommended: Business Communication Fundamentals

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Data Presentation Design is a half-day seminar and workshop that will improve your ability to create powerful data-focused presentations. Effective data presentations have tremendous power to influence the opinions and decisions of your audience. Whether you are creating presentations for internal team meetings or for large professional or public audiences, this course will teach you how to apply effective data visualization design and provides hands-on training with tools that will help you create engaging and persuasive data presentations.

By the end of the course, participants will be able to:

• Prepare engaging introductions for data-focused presentations
• Create quick and effective data presentation drafts
• Use Excel and PowerPoint to create powerful data visualizations
• Design data presentations that enhance audience attention and comprehension

Who Should Attend:
Engineers, scientists, clinicians, researchers, administrators, continuous improvement specialists, quality assurance personnel, technical professionals, management and anyone who presents data.

Prerequisites:
Participants should bring a laptop computer that has Microsoft Office to this training class. No prerequisites are necessary for this course.

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
If you believe you are a naturally great negotiator… you’ve made the first fatal error in negotiations. The people who get the worst deals on products and services are the ones who go in with the bold idea that they can out-negotiate anyone with their natural skills. This is a hands-on course that will improve your negotiation skills from 20% to 100% with internal and external customers, people in your personal life and in your career. Whether you feel youʼre a great negotiator or have room for improvement, this seminar will help you gain a keen understanding of the best way to negotiate in every situation.

By the end of the course, participants will learn to:

• Negotiate effectively with someone who only plays win/lose.
• Know when to negotiate and when to walk away.
• Get what you what, even when you are forced to make concessions.
• Move from negotiating from positions to negotiating needs.
• Negotiate effectively with people who are determined to make you lose.

Course Outline:

• Establish a base level of negotiation skills
• Gain assertiveness and confidence in your dealings with internal and external customers.
• Use power more, and negotiate less
• Become skilled at negotiating on all levels:
  • countering win/lose tactics
  • creating balanced agreements
  • creating win/win alternatives

Who Should Attend:
Professionals who need to work effectively with others inside or outside of their organizations.

Prerequisites:
No prerequisites.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
“There is a difference between being convinced with logic and believing with personal conviction.” – Nancy Duarte

You can deliver a presentation, loaded with facts and data, and while your audience may agree with the logic, they may not respond to the call. In other words, you haven’t connected with your audience and you’ve taken up valuable air space and time.

In this class you will learn how elite speakers connect and engage their audience by delivering effective presentations that combine logic, contextual understanding and needs of the audience.

By the end of the course, participants will examine:

• How to build on principles and structures from Impromptu Presenting
• Audience needs and expectations
• Tools to craft an audience centered presentation
• The art of storytelling

By the end of the course, participants will be able to:

• Deliver a message that engages your audience
• Create interest and incite action
• Establish trust by building a connection with your audience

Course outline:

• Review: Rhetorical Triangle
• Audience needs & expectations
• Creating the framework
• Methods for structure and organization
• Graphics for visual impact
• Telling the story
• Call to action / close

Who Should Attend:
Professionals who need to deliver a presentation that engages and resonates with the audience.

Prerequisites:
Recommended: Business Communication Fundamentals
Required: Impromptu Presenting

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
As the Project Manager, you’ve been asked to deliver the project status to senior management with less than 20 minutes to prepare. Part of your update includes delivering the bad news that manufacturing is having quality issues and won’t make the deadlines. What information do you need to pull together? What is your desired (presentation) outcome? How do you deliver bad news and maintain your composure? It’s imperative that your delivery is clear, logical, and addresses the needs of your audience. Your team is counting on you, and your reputation is at stake.

We will examine:

• What is your presentation goal?
• Who is your audience?
• How do you decide what information to present?
• How do you maintain composure and credibility while delivering bad news?
• How do you prepare for, and handle Q&A?

How you will benefit:

Learning how to effectively speak under pressure, in an impromptu situation, will build your reputation and impress leaders in your organization.

Course Outline:

• Know your audience
• Quick framework for presentation success
• Preparing mentally and physically
• How to engage and READ the audience
• Learn the difference between presenting to peers/management and the C-suite
• Deliver bad news with respect and composure
• How to handle Q & A

Who Should Attend:
Anyone who is asked to deliver a last-minute presentation to peers, senior management, internal and external customers

Prerequisites:
Highly recommended: Business Communication Fundamentals

Cost: Half-day class

Location: Location and driving directions will be emailed separately upon registration.

Overview:
Despite good intentions, teamwork and leadership are often hindered by different assumptions, expectations and interpersonal styles, which zap productivity and reduce trust between co-workers.  Research reveals that teamwork is strongly shaped by individual cultural values and expectations. Today’s workforce is diverse with differing ethnic, cultural and language backgrounds, causing conflicting approaches in giving information and feedback, making decisions, disagreeing and persuading, as well as differing beliefs about how to lead, be led and who to trust.

This active workshop walks participants through nine steps that align teams to improve efficiency and reduce misunderstandings.  With information from the Harvard Business School’s 10 Must Reads, The Cultural Map by Erin Meyer, That’s Not What I Meant by Deborah Tannen, and the instructor’s international experience, this course provides tools and techniques that can be used immediately to create a cohesive team culture.

By the end of the course, participants will develop strategies to help bridge silos, clarify conflict, and solve problems more effectively.

Participants will be able to:

• Explain why cultural complexity is important in communication.
• See and understand unconscious influences on communication and their impact on project team success.
• Identify the connection between cultural imprinting and conflict.
• Resolve conflict and strengthen teams by assessing values, conversation styles, and approaches to communication, work and leadership.
• Create a strategy for managing communication more effectively by understanding how people talk, listen and approach their work.
• Facilitate team activities that help inter- and cross-cultural teams to get work done efficiently and successfully.
• Develop personal communication skills that affect the success of culturally complex teams.
• Increase motivation and set performance expectations for yourself and your teams.
• Complete a lessons learned review to understand how to implement techniques immediately.

Who Should Attend:
Anyone interested in improving their communication skills to address conflict and problem solving, particularly those who work with cross-cultural and inter-departmental teams.

Prerequisites:
No previous experience is required.  Willingness to share and participate is encouraged, but voluntary.

Cost: One-day class

Location: Location and driving directions will be emailed separately upon registration.