Mastering Regulatory Audits : Strategies for Success

What Will You Learn?

• Mastering Regulatory Audits : Strategies for Success is for all pharmaceutical professionals who wants to get success into Audits.
• 1. Comprehensive Understanding of Regulatory Audits - Gain an in-depth knowledge of the regulatory audit process, including pre-audit preparations, effective audit management, and post-audit follow-up. This course covers every stage, equipping you with the skills to confidently navigate any audit.
• 2. Proven Frameworks for Audit Success - Learn and apply industry-tested frameworks like the 6 P's for pre-audit, SMART for during the audit, and CARE for post-audit phases. These frameworks provide a structured approach to ensure compliance and success in audits.
• 3. Practical Insights from Real Case Studies - Benefit from real-time case studies that illustrate common challenges and solutions during regulatory audits. These practical insights will prepare you to handle similar situations in your own audits effectively.
• 4. Effective Communication Strategies with Auditors - Understand how to effectively face and communicate with auditors. The course teaches key strategies to build rapport, handle difficult questions, and maintain a professional demeanor during audits.
• 5. Interactive Learning through Role Plays and Q&A - Engage in interactive role plays and Q&A sessions that simulate real audit scenarios. This hands-on approach helps reinforce learning and provides practical experience in a controlled environment.
• Topics Covered :-
• 1. Golden Circle of Regulatory Audit
• 2. How to Master Regulatory Audits
• 3. How to Face Auditors
• 4. Framework for Pre Audit : 6 P's
• 5. Framework for During Audit : SMART
• 6. Framework for Post Audit : CARE
• 7. Do's and Don'ts during Audit
• 8. Case Study of Audit - Real time case study
• 9. Role Play of Audit
• 10. Question & Answer