This course will provide the participant knowledge of current GMPs, how they are applied in the Bio/Pharmaceutical market today, and how they will be enforced in the future.
Topics included are:
- Impact of facility and equipment design on GMP compliance
- Risk management approach to compliance
- Commissioning, Qualification and Validation – Which one to use
- Problem resolution
- Part 11 in production and the laboratory
A comparison between 21 CFR 210/211, 600, and 810 as well as ICH guidelines will be made as they affect combination products, normal Bio/Pharmaceuticals, and Medical Devices. Current "hot" topics and examples of recent warning letters will also be discussed and evaluated.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This three-day course is designed for those who work in a current Good Manufacturing Practices (cGMP) environment (from beginner to advanced professionals) and those whose roles and responsibilities require they understand and apply cGMP quality principles to their job.
The course helps the cGMP beginner by presenting important concepts in a logical and natural sequence so they can begin to understand the concepts and begin applying them. The course also helps the both the "cGMP Intermediate" and the "cGMP Professional" by providing valuable insights that will assist them in quality decision-making, as well as, demonstrating ways to make their present systems more effective.
Those seeking to better understand and implement FDA and ICH guidance publications (e.g., "The Quality Systems Approach to Pharmaceutical cGMP Regulations", Q9), will benefit from this course as it provides practical ways to achieve the quality state in this shifting paradigm. Attendees working with combination products, biological, or APIs will also gain insight on how to better structure the quality system in order to more effectively manage compliance for multiple products.
This course is designed for personnel with all levels of cGMP experience, and will provide all participants with additional knowledge to further their careers. Upon completion of this course, attendees will:
- Be able to understand and apply GMP concepts to decision making in a managerial role
- For the beginner, the course provides guidance on how cGMPs apply to their role and responsibilities and how to apply these principles in their daily activities
- For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, and enhance their continuous improvement programs
- Understand facility and equipment design implications on the final product
- Know and understand the difference between commissioning, qualification and validation and how they are applied
- Understand and begin implementation of FDA guidance documents such as "The Quality Systems Approach To Pharmaceutical cGMP Regulations", and other important FDA and ICH guidelines
- Become knowledgeable in the GMP Risk Management approach for the 21st Century and how it applies to international harmonization
- Understand the similarities and differences between the FDA's GMP for Active Pharmaceutical Ingredients (Q7A), Drug Products (Finished Pharmaceuticals - Part 210/211), Biological (Part 600-680) and Medical Devices (Part 810)
- Know the current compliance "hot spots" that FDA and international authorities look for when inspecting for cGMP compliance
- Know how to better locate regulatory information and to interpret, assess, and make decisions concerning GMP issues