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John E. Lincoln
This webinar will define what are the US FDA's expectations for proper laboratory / clinical / manufacturing practices, systems, equipment usage, and documentation / record-keeping. It will evaluate the requirements for how basic Quality Management System (QMS) expectations/requirements are addressed in this environment. The webinar with evaluate pharma GMPs and 21 CFR 58 and associated regulations to see how the GLPs can be implemented in the real world to achieve FDA requirements and ensure the accuracy and repeatability/reproducibility of lab results.
There will be a detailed analysis of the applicable regulations for the industry. Subject areas considered are:
Areas Covered:-
Background:-
This webinar is intended to provide guidance regarding Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) for use in pharmaceutical manufacturing and clinical trials, and for use by contract laboratories that support the regulated medical products industries.
Why Should You attend:-
The Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products. The Good Clinical Practices regulations pertain to studies utilizing human subjects or clinical studies. While the GLPs do not specifically pertain to basic exploratory studies carried out to determine whether a test article has any potential utility or, for FDA studies only, to determine the physical or chemical characteristics of a test article, adherence to their principles will further ensure the accuracy of any results achieved. And the GMPs pertain to the manufacture of products to be used in trials and then in release to the field/public.
Who Should Attend:-
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
