
21 CFR Part 820 / Quality Management System Regulation
DATE: 10-11 September 2025
TIME: 9.00am – 5.15pm
ONLINE VIA ZOOM
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
DURATION
Two (2) full days
MODE OF TRAINING
Online Training
COURSE FEES (8% SST included)
Early Bird Price (until 20 August 2025)
Member: RM 1,652.40
Public: RM 1,868.40
Normal Price (from 21 August 2025 onwards)
Member: RM 1,868.40
Public: RM 2,084.40
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