ICH Q10; moving from GMPs to a Pharmaceutical Quality System

Why should you Attend:

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.

Areas Covered in the Seminar:

• ICH - original scope of activities.
• Systems based inspections and other quality systems.
• The new role of ICH - ICH Q7, ICH Q8, ICH Q9.
• Quality System Approach to Pharmaceutical CGMPs.
• ICH Q10, Pharmaceutical Quality System.
• Other, non-industry quality standards.
• Transitioning to the Pharmaceutical Quality System.

John G. (Jerry) Lanese, PH.D. CMC is the President of The Lanese Group, Inc, an independent consulting service provider that specializes in Quality Systems and Laboratory Controls. Jerry has taught at the college level and worked in various Quality Control and Quality Assurance roles in small and large pharmaceutical firms. For the last 15 years he has consulted in a wide range of projects from consent decree remedial actions with large pharmaceutical firms to systems development for a small component manufacturer