PRA is a leading consultancy company to provide best practice in the healthcare sector
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Professional Regulatory Affairs
Business village, Block B, Office # 615, Deira, Dubai, UAE
COURSES
Advanced GMP Pharmaceutical Quality Systems (GMP PQS) Auditor/ Lead Auditor Training
Accelerate Your Path to Excellence in Pharmacovigilance Auditing
Overview
This advanced 5-day training equips professionals with the knowledge and auditing skills required to assess pharmaceutical quality systems effectively. It covers internal and external auditing, supplier qualification, and GMP compliance with real-world auditing experience inside a live manufacturing facility.
Whether you’re preparing for regulatory inspections or aiming to lead internal audits, this course offers a powerful foundation for regulatory success, risk minimization, and GMP readiness.
Why Attend This Course?
- Perform real audits in a pharmaceutical manufacturing site
- Build essential auditor soft skills (communication, observation, reporting)
- Master GMP principles & regulatory requirements (ICH, FDA, SFDA, PIC/s)
- Learn to manage department audits, supplier audits, and CMOs
- Categorize audit findings: critical, major, minor
- Gain confidence in conducting self-inspections and preparing audit reports
Who Should Attend?
This course is ideal for professionals in:
- Regulatory Affairs, QA, QC, & Compliance
- Pharmaceutical Manufacturing & Packaging
- Contract Manufacturing (CMOs)
- Internal/External Auditors
- Distributors, Warehousing, & Logistics Managers
- Consultants & Quality Managers
- Third-party audit providers & certification bodies
Whether you’re preparing for MOHAP, SFDA, JFDA, PIC/s or international inspections this course is designed for you.
What You Will Learn
- Fundamentals of GMP PQS & audit processes
- Risk-based approach to auditing
- Preparing audit plans, conducting, and closing audits
- Performing supplier, CMO, site, and internal audits
- Writing audit findings and performing follow-up (CAPAs)
- Common audit trends: US FDA 483s, Warning Letters, MHRA, PIC/s
Course Modules Include
- Audit Principles & Planning
- Auditor Competency & Skills
(incl. communication, resistance handling, note-taking) - Audit Types: Internal, External, Self-inspections
- Audit Execution & Report Writing
- Regulatory Documentation Review (SOPs, SMF, Quality Manual)
- Audit Closure & CAPA Follow-up
- Live GMP Audit at a Local Manufacturing Site
Download Our Brochure
- You can easily download our brochure by clicking the button below. Alternatively, feel free to reach out to us via WhatsApp for assistance.
Obtain a Certificate Upon Completion
Upon successfully completing our course, you will receive a prestigious certificate that:
- Recognizes your achievements and newly acquired skills
- Serves as tangible proof of your expertise
- Accredited with CME Points by Dubai Health Authority
- Prestigious certificate from Dubai Pharmacy College.
Enroll today to Professional Regulatory Affairs GCC Course Certification
Frequently asked questions
Everything you need to know about our top-rated Webflow Masterclass course.
This course is suitable for both beginners and experienced professionals in pharmacovigilance, including PV auditors, quality assurance professionals, regulatory affairs specialists, and clinical research professionals.
A basic understanding of pharmacovigilance concepts is beneficial. A bachelor’s degree in a relevant field (e.g., pharmacy, medicine, life sciences) is recommended.
The course is conducted online via live sessions twice a week, from 10:00 AM to 2:00 PM (UAE Time).
The course covers four main modules: Quality Pharmacovigilance Requirements, QPV Audit Aspects, QPV Audit Concerns, and QPV Report & Findings.
You’ll gain enhanced knowledge in PV auditing, a recognized certification, practical experience through case studies, and increased employability in the pharmaceutical industry.