This webinar will define what is the US FDA's expectations 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 GLPs can be implemented in the real world to achieve FDA requirements and ensure the accuracy and repeatability/reproducibility of lab results. It will further consider the USP 1058 requirements for lab equipment and analytic methods validations. There will be a detailed analysis of the applicable regulations for the 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

Areas Covered:-

• Key Regulatory Expectations
• GLP and USP Specifics 
• Systems, personnel, Facilities 
• Required documentation/records
• Control of equipment/test material/samples 
• Laboratory Controls in the CGMPs
• Validations

Background:-

This webinar is intended to provide guidance regarding Good Laboratory Practices (GMP) and lab equipment and analytical methods validation 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 regulations do not pertain to studies utilizing human subjects or clinical studies for which the current Good Clinical Practice (GCP) 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 the physical or chemical characteristics of a test article, adherence to their principles will further ensure the accuracy of any results achieved. The related USP 1058 provides recommended practices for the validation of lab equipment and analytical methods.

Who Should Attend:-

• 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.