6-Hour Virtual Seminar on GCP/GLP/GMP : Comparison and Understanding of the FDA's 3 Major Regulations
Product Id : 11261
Price Details
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 specificall 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 articl, adherence to their principles will further ensure the accuracy of any results achieved. And the GMPs pertain to the manufacture of product to be used in trials and then in release to the field / public.
Why you should attend
This webinar will define what are the US FDA's expectation 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 these 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 repeatibility / reproducibility of lab results. There will be a detailed analysis of the applicalbe regulations for 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
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, Logistics and V&V Responsibilities
- Key Regulatory Espectations
- GLP/ GCP / GMP specifics
- Systems, Personell, Facilities
- Required documentation / records
- Control of equipment / test material / samples
- Laboratory Controls in the CGMPs
- Clinical documents
- CGMP requirements
- Validations