The Center for Professional Innovation & Education, Malvern, PA
August 10-12, 2009
Who Should Attend This three-day course is designed for those who work in a current Good Manufacturing Practices (cGMP) environment and whose roles and responsibilities require they understand and apply cGMP Quality principles. The course helps the cGMP beginner by presenting important concepts in a logical, predictable, and natural sequence so they can readily begin to understand the concepts and begin applying them. The course 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 the FDA's 2006 guidance publication, “Quality Systems Approach to Pharmaceutical cGMP Regulations; & ICH Q10, Pharmaceutical Quality System” will benefit from this course as it provides practical ways to achieve the quality state in this shifting paradigm. Attendees working with combination products, will also gain insight on how to better structure the quality system in order to more effectively manage compliance for multiple products.
Learning Objectives This course is designed for personnel with all levels of cGMP experience. It will provide cGMP knowledge so they may advance 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
- 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 make improvements
- Understand and begin implementation of the FDA's 2006 guidance, The Quality Systems Approach To Pharmaceutical cGMP Regulations as well as Q10, Pharmaceutical Quality System
- Know the similarities and differences between the FDA's GMP Quality Systems for Active Pharmaceutical Ingredients (Q7A), Drug Product (Part 210/211), Biologicals (Part 600-680) and Medical Devices (Part 820 & ISO 13485)
- Learn the relationships of all the CGMPs to other FDA regulations and to the medical products life cycles
- Have working knowledge of international cGMP in regulations
- 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
Course Description
This course is intended to give participants a thorough understanding of cGMP principles, as well as, tools that may be used in developing and managing current Good Manufacturing Practices. Pictures, flow diagrams, examples of actual procedures and warning letters are included in the presentation to demonstrate basic cGMP concepts. Participant interaction is desired and encouraged.
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