ICH Q10; moving from GMPs to a Pharmaceutical Quality System

This ICH Q10 training /webinar 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.

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.

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.

Who will Benefit:

• Senior management representing all departments or units
• QA directors who will be responsible for the implementation of a quality system
• Middle management