Risk-Based Approach to Manufacturing: ICH Q8, ICH Q9/ISO 14971 – EUGENE

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 ISO 14971 (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 ISO 14971, 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 ISO 14971 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
• ISO 14971
  • Pharmaceutical quality system principles
  • Relationship to GMPs
  • Continual improvement of product quality and quality system
• How ICH Q8, Q9, and ISO 14971 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.