Good Auditing Practices, Making the Most of Your Internal Review

FDA regularly audits facilities for compliance with GMPs, shouldn’t you?

Regular and formal internal audits provide a clear, unbiased view of your facility operations and uncover challenges that must be addressed. No matter your FDA regulated industry, having a formal, thorough and documented audit plan will streamline your audit processes and ensure replicable efforts that track progress.

Learn the fundamentals of developing an audit program with EAS Consulting Group’s seminar Good Auditing Practices. This eight-hour seminar will detail design and implementation strategies to ensure your audit program meets the high level of detail expected by FDA field auditors.

You’ve designed a robust GMP system for your manufacturing facility. Shouldn’t your audit program have the same level of detail?

Topics Covered

• GMP Overview
• Good Auditing Practices
• The Facility Tour
• Auditing Documents and Records
• Auditing Personnel, Training & Hygiene
• Auditing Physical Plant and Grounds
• Auditing Equipment, Utensils & Instrumentation
• Auditing Quality Control and Quality Assurance
• Auditing Components, Packaging and Labeling
• Auditing Lot Control, Tracking and Traceability
• Auditing Master Manufacturing and Batch Production Records
• Auditing Specifications, Testing and Finished Product Release
• Auditing Laboratory Operations
• Auditing Investigations, Non-Conforming Products and Corrective and Preventative Actions
• Auditing Holding and Distribution
• Auditing Product Complaints
• Auditing Close-Out, Report and Follow-up
• Discussion and Next Steps