GMP Lead Auditor

Summary

Dive into the World of GMP Auditing Excellence! Explore the regulatory landscape (EU-GMP, CFR, ICH, EMA, FDA, PIC/S) and master the art of smart GMP audit preparation. Uncover the secrets of classifying audit findings, debate the necessity of classifications, and understand regulatory backgrounds and authorities’ expectations. Engage in break-out sessions with real-world examples, discussions, and insights on behavior in specific conflict situations. Explore the FDA’s critical requirements on commercial readiness, from investigations to material handling, with practical examples. Discuss the scope of data integrity, including auditing raw data, ensuring factual and contextual integrity, and securing data. Collaborate in workshops to navigate conflict situations, understand perspectives, manage difficulties, and create effective audit reports. Don’t miss the chance to elevate your GMP audit management skills, share experiences, and gain practical insights.

Learning Objectives

• Regulatory Landscape
• FDA Requirements
• Commercial Manufacturing Readiness
• Data Integrity
• Experience exchange with the other participants on a multicultural platform
• Examples from real audits with workshops and role play
• Audit finding classification systems
• Smart strategies for the planning and execution of audits
• Strategies for problem solving
• Communication strategies
• Trouble shooting
• Knowledge tests
• Workshops
• Break-Out sessions with real audit examples

Key Topics

• Regulatory background (EU-GMP Guideline, CFR, ICH, EMA, FDA guidance and the PIC/S)
• ISO19011
• Practical examples from real audits
• Risk oriented planning
• Audit plans, check lists and reports
• Classification of audit findings
• CAPA-plans
• Management of difficult situations
• Experience exchange
• Cultural differences
• Problem solving strategies
• Communication strategies for audits
• Authority Requirements for Commercial Manufacturing
• Break-out Sessions: Practical Examples and Behaviors
• Check of Conformance to Application
• Check of Data Integrity Compliance

Who should attend?

Everyone who is concerned with GxP audits, for example: GMP Auditors, QA Professionals, CMO and CLO Managers and Representatives, Manufacturing Experts, Quality Control Experts, Regulatory Affairs Managers, Validation Experts, Supply Chain Managers, Sales Representatives, IT Managers in the fields of GxP, EHS Managers.

The course is designed for beginners, advanced expert GMP auditors.

Our online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer
• Q&As, case studies, polls
• Revisit recorded sessions for 7 days
• Training in digital format
• Digital and LinkedIn certificates