Overview
This webinar is intended to provide guidance regarding Good Laboratory Practices (GMP) for use in pharmaceutical manufacturing and non-clinical tests, and for use by contract laboratories that support the regulated medical products industries .
This webinar will define what are the US FDA's expectation for proper laboratory 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 the lab environment. The webinar with evaluate pharma GMPs and 21 CFR 58 and associated regulations to see how the GLP's 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 industry. Subject areas considered are:
- Lab Control / Systems
- Facilities and Equipment
- Documentation and Records
- Materials Management
- Personnel / Assignments
- Validation
- The Lab GLPs and company CGMPs
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 regulations do not pertain to studies utilizing human subjects or clinical studies for which the current Good Clinical Practice (cGCP) standards would apply, although they support the GCPs. 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 physical or chemical characteristics of a test article, adherence to their principles will further ensure the accuracy of any results achieved.
Webinar Takeaway
- Key Regulatory Espectations
- GLP specifics
- Systems, Personell, Facilities Required documentation / records
- Control of equipment / test material / samples
- Laboratory Controls in the CGMPs
- Validations
Who Will Benefit
- Senior management in Devices, Pharma, Combination Products
- QA / RA
- Medical products development and testing testing teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants; others tasked with medical product development, manufacturing and testing/V&V responsibilities
Faculty John E Lincoln
Principal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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 including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of
