GMPs in the 21st Century - How the interpretation and enforcement of the GMPs is evolving
The existing GMPs were finalized in 1979 and the industry has changed considerably since that time. In 2001 the FDA announced to the pharmaceutical industry that it would regulate the industry based on good science and risk. Since that time the Agency has partnered with ICH in the release of ICH Q8, Pharmaceutical Development, ICH Q9, Risk Management and ICH Q10, The Pharmaceutical Quality System. FDA has also issued guidances on Process Validation, Quality Metrics and Data Integrity. All of these provide contemporary interpretation for a quality system approach to the enforcement of the existing regulation, the drug GMPs, 21CFR211.
The objective of this webinar is to inform personnel involved with GMP operations in a pharmaceutical firm how the FDA is transitioning the interpretation from the regulation as written in 1978 to a more modern, quality system based interpretation.
Areas Covered in the Session :
In this webinar we will discuss guidances issued by the FDA since the turn of the century and how these bring a contemporary interpretation to the drug GMPs.
• Guidance documents discussed will include:
• ICH Q8; Pharmaceutical Development
• ICH Q9; Quality Risk Management
• ICH Q10; The Pharmaceutical Quality System
• Guidance for the Industry, Process Validation
• Guidance for the Industry; Quality Metrics (Draft)
• Guidance for the Industry; Data Integrity (Draft)
The discussion will be enforced by recent observations which will be used to clarify the regulatory emphasis on science and risk and its current interpretation of the GMPS.
Who Will Benefit:
• The following individuals should attend this audio seminar:
• Senior management
• Quality Assurance and Quality Control management
• Operations management
• line personnel in Quality and Operations
Speaker Name: Jerry Lanese
Price : $ 239
Tuesday August 16, 2018
Duration : 90 Minutes
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|Target State: Maryland|
Target City : All Cities
Last Update : Aug 02, 2018
Number of Views: 42
|Item Owner : Compliance Training Panel|
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