Mastering Regulatory Audits : Strategies for Success

Navigate, Communicate, and Excel in Every Regulatory Audits

What you’ll learn
Mastering Regulatory Audits : Strategies for Success is for all pharmaceutical professionals who wants to get success into Audits.
Golden Circle of Regulatory Audit
How to Master Regulatory Audits
How to Face Auditors
Framework for Pre Audit : 6 P’s
Framework for During Audit : SMART
Framework for Post Audit : CARE
Do’s and Don’ts during Audit
Case Study of Audit – Real time case study
Role Play of Audit
Question & Answer

Requirements
No prior skills required.

Description
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.
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
Who this course is for
This course is designed for professionals in the pharmaceutical and biopharmaceutical industries who are responsible for ensuring regulatory compliance. It is tailored for individuals seeking to enhance their knowledge and skills in managing regulatory audits effectively. The intended learners for this course include
Quality Assurance (QA) Professionals: Seeking to deepen their understanding of audit processes and improve compliance strategies.
Regulatory Affairs Specialists: Looking to stay updated on best practices for audit preparation and execution.
Manufacturing Supervisors and Managers: Interested in ensuring that their operations meet regulatory standards.
Compliance Officers: Responsible for maintaining and enforcing regulatory compliance within their organizations.
Project Managers in Pharma/Biopharma: Needing to integrate audit readiness into their project planning and execution.
Engineering Professionals in Pharma: Focused on aligning technical operations with regulatory requirements.
Consultants: Offering services to pharmaceutical companies and needing a thorough understanding of the audit process.
New Entrants in Pharma/Biopharma: Wishing to gain foundational knowledge in regulatory audits to build a strong career.
Training and Development Managers: Tasked with upskilling their teams in regulatory compliance and audit preparedness.