This course is intended for all levels of experience in GMPs and focuses on beginner to intermediate level professionals. It will provide participants with an insight to the current GMPs as outlined in 21 CFR 210/211. The course covers the foundations of the regulations and how they are applied in the bio/pharmaceutical and device market today and near future.
Topics included are:
- Impact of facility and equipment design on GMP compliance
- Risk management approach to compliance
- Vendor qualification
- Commissioning, Qualification and Validation – Which one to use
- Problem resolution
- Part 11 in production and the laboratory
- Quality Systems
Examples will be taken from the three industries (e.g., 21 CFR 210/211, 600, and 820 as well as ICH guidelines and EU regulations). Current “hot” topics and examples of recent warning letters will also be discussed and evaluated.
Who Should Attend
This three-day course is designed for those who work in a current Good Manufacturing Practices (cGMP) environment (beginners to advanced professionals). It is also designed for those whose roles and responsibilities require that they understand and apply cGMP quality principles to their job.
The course helps the cGMP beginner by presenting an overview of the important concepts in a logical and natural sequence so they can begin to understand GMP regulations and begin applying them. The course is also designed to help both the “cGMP Intermediate” and the “cGMP Professional” by providing valuable insights and examples that will assist them in their quality decision-making, as well as, demonstrating ways to make their present systems more effective.
This course concentrates on 21 CFR 211 which is for finished pharmaceutical GMPs, however, these regulations apply equally to the biotech and device industries. The issues and examples presented are taken from all three regulated industries. The implications of ICH guidance publications (e.g., “The Quality Systems Approach to Pharmaceutical cGMP Regulations”, Q9) and EU regulations will also be discussed. As this course addresses cGMP regulations, attendees working with finished pharmaceuticals, combination products, biologicals, APIs or devices will gain insight on how to better structure their respective quality systems in order to more effectively manage compliance for multiple products.
This course is designed for personnel with all levels of cGMP experience. It will provide participants with cGMP knowledge so they may advance their careers and be prepared for additional responsibilities. Upon completion of this course, attendees will:
- Be able to understand and apply GMP concepts to decision making in a managerial role
- Understand facility and equipment design implications on the final product
- Know and understand the difference between commissioning, qualification and validation and how and where they are applied
- Understand and begin implementation of the FDA guidance documents such as “The Quality Systems Approach To Pharmaceutical cGMP Regulations”, and other important FDA and ICH guidelines
- Become knowledgeable of the GMP Risk Management approach for the 21st Century and how it applies to international harmonization
- 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 interpret, assess, and make decisions concerning GMP issues