13-14 October: 21 CFR Part 820 / Quality Management System Regulation

21 CFR Part 820 / Quality Management System Regulation

DATE: 13-14 October 2025

TIME: 9.00am – 5.15pm

VENUE: Iconic Marjorie Hotel, Penang

DURATION: 2 full-day course

COURSE OBJECTIVES
After participating in the training, you will be able to:

• Identify key requirements and components of the US FDA 21 CFR Part 820 Quality System Regulation (QSR).
• Interpret regulatory expectations for compliance.
• Implement best practices for maintaining quality and regulatory compliance.
• Prepare for FDA Inspection.
• Understand key highlights of the new Quality Management System Regulation (QMSR).

COURSE OUTLINE

1. Introduction to US Food and Drug Administration (FDA), Federal Food, Drug, and Cosmetic
   Act (FD&C Act), Code of Federal Regulations (CFR), and QSR
2. QSR: Section by section requirements deep dive
3. US FDA 21 CFR Part 820 mandatory documentation
4. FDA Inspection
5. QMSR: Key changes
6. QSR vs QMSR section comparison
7. QMSR: Section by section requirements interpretation

CONTACT
For enquiries, please email to Medsociate Sdn Bhd
Authorised training provider of AMMI
Email: learning@ammi.com.my / admin@medsociate.com
Tel: +6012 539 4194