Advanced Diploma in Quality & Compliance Management

Weekly Breakdown

Module 1: DMS & Documentation Strategy (Weeks 1–6)

Module 2: QMS Frameworks (Weeks 7–12)

Module 3: Deviation, RCA & CAPA (Weeks 13–18)

Module 4: Audit & Risk Management (Weeks 19–24)

Term and Credit Structure

Learning Outcomes & Assessment

Program Details

🕰️ Duration:
6 Months (24 Weeks)
📚 Terms Info:
2 Terms | 4 Intensive Modules
🧩 Structure:

4 Intensive Modules + 1 Mock Audit Capstone
🧠 Delivery:

QMS Software Simulations, RCA Workshops, Documentation Labs
🎯 Focus On:

Quality Management & Compliance Training

🎓 Applicable Audience

B.Pharm M.Pharm D.Pharm BPT BHMS BAMS BDS MBBS Nursing B.Sc BA BCOM MCOM BTECH MTECH MA

Detailed Syllabus & Weekly Breakdown

Module 1: DMS & Documentation Strategy (Weeks 1–6)

Drafting SOPs, Work Instructions, and Forms
ALCOA+ principles and Good Documentation Practices (GDP)
Version control and document lifecycle management

Module 2: QMS Frameworks (Weeks 7–12)

Deep dive into ISO 9001 and ISO 13485
Understanding Quality Manual and Quality Policy
Change Control management and Vendor Qualification

Module 3: Deviation, RCA & CAPA (Weeks 13–18)

Investigating Deviations; Root Cause Analysis (Fishbone, 5-Whys)
Designing CAPA plans; Issue Logs and Tracking
Impact assessment and trending of quality events

Module 4: Audit & Risk Management (Weeks 19–24)

Internal vs External Audits (FDA, EMA, CDSCO)
Handling non-conformances; Risk Management (FMEA)
Capstone: Conducting Mock Audit and Audit Report

Term and Credit Structure

Term	Module	Weeks	Core Focus	Credits
Term 1	Module 1: Document Management (DMS)	1–6	SOPs, Forms & Record Integrity	4
Term 1	Module 2: QMS Frameworks & Standards	7–12	ISO, GxP & Quality Policy	4
Term 2	Module 3: Deviation, RCA & CAPA	13–18	Issue Management & Resolution	4
Term 2	Module 4: Audit Readiness & Leadership	19–24	Mock Audits & Risk Strategy	4

Learning Outcomes & Assessment

Outcomes: Design a compliant QMS, lead RCA investigations, maintain audit-ready documentation
Assessment: SOP Drafting (25%), RCA Case Study (25%), Mock Audit Performance (50%)