Overview
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.
Why you should Attend:
This seminar 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 seminar 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:
- Lab / Clinical / Manufacturing Control / Systems
- Facilities and Equipment
- Documentation and Records
- Materials Management
- Personnel / Assignments
- Validation
- The Lab GLPs, IRBs/GCPs, and company CGMPs
Agenda:
- Key Regulatory Expectations
- GLP/ GCP / GMP specifics
- Systems, Personnel, Facilities
- Required documentation/records
- Control of equipment/test material/samples
- Laboratory Controls in the CGMPs
- Clinical documents
- CGMP requirements
- Validations
Who Will Benefit:
- Senior management in Devices, Pharma, and 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
Faculty John E. Lincoln
Principal of J. E. Lincoln and Associates LLC
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.
4.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 4.0 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
