“Testing lies at the heart of a drug manufacturer’s successful operation.” This is a statement that can be found at the beginning of the famous 1993 court decision, the Wolin decision, also known in the pharmaceutical industry as the Barr decision. Judge Wolin also expressed the opinion that the mechanics of test-taking are left undefined by the regulations. The Wolin Decision and the FDA concerns over industry practices at the time opened the doors of the pharmaceutical industry Quality Control Laboratories to continual inspection and observation. Inadequate control of laboratory operations has resulted in many 483 and warning letter observations.
It is the FDA view that the GMPs, specifically subparts I and J provide an adequate overview of systems required for compliant laboratory operations and it is the responsibility of the individual pharmaceutical firm to implement specific policies, procedures and practices that define compliant quality control laboratory operations specific to its business and products.
The policies and procedures are generally referred to as Laboratory Controls, consistent with 221CFR211 Subpart I, Laboratory Controls. In this audio seminar we will discuss Laboratory Controls that are required in our current economic and regulatory environment.
In this webinar, our expert speaker Jerry Lanese will begin with a discussion of contemporary regulatory guidance and its impact on Laboratory operations. Specific guidances will include: ICH Q10, The Pharmaceutical Quality System, ICH Q8, Pharmaceutical Development and ICH Q9, Risk Management.
Jerry will then discuss the statements found in 21CFR 211, specifically subparts I and J and apply them to the current pharmaceutical industry environment. At the end, you will walking out with a better understanding of contemporary expectations for laboratory operations.
The following areas will be covered in this audio seminar:
Who Should Attend
The following individuals will benefit
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Dr. David Lim
Dr. 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...
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