This training explores how to prepare for an FDA inspection of a combination product or device. Combination products are defined along with a brief explanation of the Primary Mode of Action. The QSR and GMP regulations are discussed in reference to combination products. Inspection agendas and examples are given. What is emphasized during the inspection vs. what is in the application is discussed. How to avoid common pitfalls with combination products and strategies for a successful approval inspection are discussed. Know key behaviors for a successful combination product or device inspection.
Objectives of the Presentation:
- How to prepare for an FDA inspection
- What to expect when FDA shows up
- Inspectional Strategy
- QSR and GMPs
- Demonstrating Compliance
- How to respond to an FDA 483
Why Should You Attend?
Good Manufacturing Practice (CGMP) requirements for combination products that FDA issued on January 22, 2013 (final rule) (21 Code of Federal Regulations (CFR) part 4). Prior to issuance of the final rule, although CGMP regulations were in place to establish requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), there were no regulations to clarify and explain the application of these CGMP requirements to combination products.
The final rule did not establish any new requirements; it was intended to clarify which CGMP requirements apply when drugs, devices and biological products are combined to create combination products, and to set forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with applicable CGMP requirements.
- Consideration for CGMP Compliance
- CGMP Requirements Specified 21 CFR 4.4(b)
- QSR and CGMP
- How to respond to an FDA 483
The final rule did not establish any new requirements; it was intended to clarify which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products, and to set forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with applicable CGMP requirements.
Kenneth F. Miles,
Miles Technologies Group
Dr. Kenneth F. Miles is a seasoned professional in Quality, Regulatory and Clinical affairs and development strategy for drugs, biologics, medical devices and combination products. He has worked in senior quality and regulatory roles in the medical products industry for more than 20 years. Dr. Miles has worked for a number of large and small pharmaceutical, biotech and medical device companies. He also interfaced with FDA at Local, District and Centre levels and has dealt with several foreign ministries to bring companies into compliance. He has set up regulatory and quality systems for countries around the world, including the Pacific Rim, Europe and South America. He is the senior member of the American Society for Quality, (Certified Quality Engineer) and member and Fellow of Regulatory Affairs Professional Society (Certified Regulatory Affairs). Dr. Kenneth F. Miles is the recipient of the GMP Institute Hall of Fame Award.