Overview:     
Quality Systems (QS) are sometimes viewed as a necessary evil or as belonging only to production and QA personnel. However, an 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 a QS that matches 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!

How You Will Benefit:
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 a QS;
• Methods for adapting your QS to be most effective

Course Outline:

• Introduction to FDA and ISO
• Lifecycle of a Quality System (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 QS. Recommended for those in customer service, purchasing, manufacturing, engineering, quality assurance, or related disciplines. Prerequisites: There are no prerequisites.

Cost:
Half-day class
Cost: $125 (includes class, all class materials, and snacks)

Instructor Bio:  Linda J. Bovard, RAC
Linda J. Bovard is President of Bovard Consulting LLC. She provides regulatory consulting services to FDA-regulated companies, primarily in the medical device arena. Her services include strategic planning, pre-market submissions, labeling, training, and development, improvement, and auditing of Quality Systems. She has provided services to medical device companies for over 25 years, more than 15 years as a consultant. She has worked with entrepreneurs, virtual companies, start-ups, established small companies, and large conglomerates. Products range from sophisticated electronic devices with software to IVDs to personal use devices. Linda has a BA in Biology from Swarthmore College. She is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society and is a Certified Hazardous Materials Manager (CHMM) from the Institute of Hazardous Materials Management. She is committed to continuing education to keep up-to-date in this constantly changing field. She also passionately believes that understanding FDA is crucial for the success of regulated companies.