Webinar On "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.

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.

The following individuals should attend this audio seminar:

• Senior management
• Quality Assurance and Quality Control management
• Operations management
• line personnel in Quality and Operations

John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where he has managed Analytical Research, Quality Control and Quality Assurance functions.

In 1994 Dr. Lanese formed his own company, The Lanese Group, and since that time he has been a consultant in the area of quality system and cGMP compliance and has audited and consulted with small and large medical device and pharmaceutical companies, including companies under FDA Consent Decree, API and excipient manufacturers, electronic firms and other manufacturing organizations.