Integrating GMPs and the Pharmaceutical Quality System


The objective of this course is to make the attendee aware of how the drug GMPs, 21CFR211, have become outdated and how the FDA is using guidance documents to update the interpretation of 21CFR211 so that it is consistent with contemporary quality systems. The session will also discuss how current FDA expectations that go beyond the requirements found in 21CFR211.

This webinar should be attended by personnel in supervisory, middle management and senior management positions in the pharmaceutical industry.

Jerry Lanese is an independent consultant to FDA regulated industries. He received BA and MS degrees from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and served in the Chemical Corps of the U.S. Army. He taught Chemistry in a well-known college and then moved into the pharmaceutical industry where he held management positions in Quality Control and Quality Assurance. 

In 1994, Dr. Lanese formed his own consulting organization. He has consulted on projects in large and small pharmaceutical, medical device and electronic firms. Some of these have been under FDA Consent Decree. Jerry has written many articles for journals, including a continuing column in the Journal of GXP Compliance, “GXP Talk”. 

Dr. Lanese focuses on Quality Systems, the elements of a Quality System, Laboratory Controls and Analytical Method Validation


The FDA  (and ICH) published ICH Q10, The Pharmaceutical Quality System. In 2008 and the interest and regulatory focus on this guidance has grown over the past ten years . In this 60 minute session we will discuss how the systems identified in ICH Q10 integrate with the requirements defined in 21CFR211, the Drug GMPs. We will discuss how ICH Q10 provides clarity and broadens the GMP requirements and how it adds contemporary expectations beyond what is spelled out in the antiquated GMPS.

The current regulation for the production and control of drug products, 21CFR211 was released in 1978. The drug industry has grown well beyond what it was in 1978 in production technology and product type and the regulations have not kept up. FDA has released a series of guidance documents that enhance and expand upon 21CFR 211. The current pharmaceutical professional must understand what in the guidance provides contemporary clarification to the regulatory requirements and what identifies contemporary expectations that support the GMPs.

  • $195.00