Thursday August 16th 2018
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
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.
Dr. Lanese focuses on training. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers. Jerry is a member of the Editorial Board of the Journal of GXP Compliance.
Organizer: Compliance Training Panel
Each booking includes Event Protect
This event is covered by Event Protect. If the event is cancelled, you can apply for a refund directly from Event Protect provided the cancellation is covered by their insurance policy. Learn more about Event Protect
Thursday, August 16th 2018
Ends: Thursday, August 16th 2018 at 2:30pm
Bookings close: August 16th 2018