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