This 4 hr webinar on ICH Q-10 Quality System and the FDA's Quality Systems Approach (QSA) to the Pharmaceutical cGMPs will discuss and analyze in detail the purpose, scope, objectives, and content of these guidances.
Why Should You Attend:
The QSA to Pharmaceutical cGMPs and ICH-Q10 are guidance documents that stress the importance of management's responsibilities to meet customer needs by encompassing quality improvement through quality by design QbD), risk management, process control, and user feedback and experience.
This 4 hour course will provide the attendees with the knowledge and insight required to understand and apply the principles and concepts of ICH –Q10 and the Quality Systems Approach. This new paradigm forces industry leaders to rethink their roles in meeting corporate objectives and strategies.
It challenges the FDA to focus on the importance of user requirements and assessing results with less importance on compliance to inflexible rules and regulations. The key message is Senior Management must be actively involved in quality operations because it is they who have the authority and responsibility to control and demand that corrective action be taken to ensure quality issues are addressed openly and effectively.
This course will discuss and analyze the purpose, scope, objectives, and content of this guidance. Similarities and differences will be shown. Graphics and personal experience cases are widely used to explain principles and concepts. Its present enforcement status will be provided. Questions and answers will be highly encouraged.
4 hours instruction, 15 min break
Agenda: Eastern (Pacific)
- 1:00-1:50pm (10:00-10:50am Pacific) Module 1: The current quality and regulatory paradigm
- 1:50-1:40pm (9:50-10:40am Pacific) Module 2: Dissecting and Analyzing the FDA's Quality Systems Approach (FQSA) and ICH-Q10
- 1:40-2:20pm(10:40-11:20am Pacific)Module 3: Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulation
- 2:20-2:35pm (11:20-11:35am Pacific) Break
- 2:35-3:15pm (11:35am-12:15pm Pacific) Module 4: ICH-Q10-Pharmaceutical Quality Systems - Objectives
- 3:15-3:30pm (12:15-12:30pm Pacific) Module 5: ICH-Q10- Management Responsibility
- 3:30-4:00pm (12:30-1:00pm Pacific) Module 6: Continual improvement of process performance, product quality and the Pharmaceutical Quality System
- 4:00-4:15pm (1:00-1:15pm Pacific) Q&A (0:15)
Note: Use this promocode(117660) for 10% discount.