FDA Guide to Inspections of Pharmaceutical Quality Control Laboratories Key Requirements, Defense Strategies for Regulatory Audits, and Understanding Quality Assurance vs. Quality Control Inspections

The Food and Drug Administration (FDA) conducts inspections and assessment of the Quality Control (QC) laboratories to determine if the organization comply with applicable law and regulations such as Good Manufacturing Practices (GMPs). The QC laboratory serves one of the most important pharmaceutical manufacturing and control functions because it provides analytical data and results of product release and stability studies according to the product registration to monitor product quality in the market. At the minimum, the QC laboratory should receive a comprehensive GMP evaluation every two years to maintain their obligation.

This live, instructor-led session with Kim Huynh-Ba provides a detailed examination of the FDA Guide to Inspection of Pharmaceutical Quality Control Laboratories, covering the essential functions of the quality control professional and the critical compliance areas that laboratory and quality personnel must understand to ensure regulatory compliance and effectively defend their positions during a regulatory inspection. The session discusses different types of audits and inspections, and examines the key areas of the FDA Guide that serve as an independent mechanism to verify that GMP requirements are in place within both internal and external laboratory operations. Topics include the distinction between Quality Assurance and Quality Control functions, performance-based quality systems, documentation practices, OOS investigation management, CAPA effectiveness and change control. Given its comprehensive coverage of GMP compliance essentials for QC laboratory operations, this session is well suited as a core component of any GMP training program for quality control laboratories. Attendees will leave with a clear understanding of regulatory expectations and practical knowledge applicable to both internal quality programs and external regulatory audits.

Learning Benefits

• Compare Quality Assurance vs. Quality Control.
• Explain job functions and quality roles.
• Discuss different types of quality inspections.
• Understand expectations from the FDA Guide to Inspection of QC Lab.
• Perform effective quality auditing techniques.
• Understand performance-based quality systems.
• Improving documentation practices on the validation.
• Managing non-conformances, deviations, and complaints.
• System to track OOS investigations and CAPA effectiveness.
• Provide support to change management.

Who should attend:

The following individuals or disciplines will benefit from attending this Webinar:

• Quality Assurance Personnel
• Quality Control Personnel
• Research and Development
• Regulatory Affairs Professionals
• Auditors
• Validation