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The GCPs/GLPs/GMPs: Comparison and Understanding of the FDA’s 3 Major Regulations
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 the lab environment. The webinar with evaluate pharma GMPs / CFRs and associated regulations to see how these GXP's can be implemented in the real world to achieve FDA requirements and ensure the accuracy and repeatability / reproducibility of lab / clinical / manufacturing results. There will be a detailed analysis of the applicable regulations for industry. Subject areas considered are:
- Lab / Clinical / Manufacturing Controls / Documentation / Systems
- Drug CGMPs
- ICH Q7, Drug API’s GMPs
- The Drug compliant lab
- Facilities and Equipment
- Documentation and Records
- Materials Management
- Personnel / Assignments
- Validation.
Overview of the webinar
This webinar provides guidance regarding Good Laboratory Practice, Good Clinical Practice and God Manufacturing Practices for use in pharmaceutical manufacturing and clinical trials, and for use by contract laboratories that support the regulated medical products industries.
Who should attend?
- Senior management in Devices, Pharma, Combination Products
- QA / RA
- Medical products development and testing teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants; others tasked with medical product development, manufacturing, logistics and V&V responsibilities
Why should you attend?
These GXP regulations describe the minimal standards for conducting nonclinical laboratory studies, basic clinical trial practices and Good Manufacturing Practices for devices / pharmaceuticals 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 and reproducibility of any results achieved.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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 including 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 ptublished 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.