Since the release of the Quality System Regulation for medical devices, the FDA has been trying to transition the pharmaceutical industry to a Quality System approach to compliance. The issuance of the Guidance for the Industry: Quality System Approach to Pharmaceutical CGMPS and ICH Q10. Pharmaceutical Quality System has brought new focus to Quality Systems in the pharmaceutical industry. This seminar will discuss the transition in the FDA oversight from a strict audit against the regulations as defined in the GMPs to a review of the high level quality system and the involvement of senior management in compliance to the GMPs.
The discussion will begin with the establishment of ICH and its original purpose to facilitate registrations throughout the world and discuss the impact of Quality systems such as ISO 9000 and the medical device GMPs. It will continue with the effort of the agency to change the way it regulates and the impact of the international focus on Quality Systems and how ICH broadened its scope and responded to the international move to a quality systems approach.
This seminar will discuss the evolution and interpretation of the pharmaceutical GMPs as a quality control regulation to the Quality Assurance emphasis of the Pharmaceutical Quality System as defined in ICH Q10, Pharmaceutical Quality System and the FDA Guidance, Quality System Approach to Pharmaceutical CGMPs with a focus on the involvement of senior management in the accomplishment of the quality objectives of the pharmaceutical firm. This session will help the participants understand the Pharmaceutical Quality System and how it might be implemented.