Course Content
Day 1: Advanced GMP Fundamentals
0/4
Lesson 1: Pharmaceutical /quality System
Lesson 2: Quality risk management integration
Lesson 3: International Regulatory framework
Case Study Common GMP Compliance Failures
Day 2: Production operations
0/6
Lesson 1: Personnel
Lesson 2: Materials
Lesson 3: Equipment
Lesson 4: Production
Lesson 5: Contract Analysis and Contract Manufacturing
Workshop: Contamination Control
Day 3: Quality Control, Documentation, Data Integrity
0/6
Lesson 1: Good Documentation Practices (GDP)
Lesson 2: Document Control
Lesson 3: Data Integrity and ALCOA+ Principles
Lesson 4: Quality Control
Lesson 5: Self-inspection
Case Study: Documentation Errors During Inspection
Day 4: GMP Audits & Inspection Readiness
0/6
Lesson 1: Internal GMP Audits
Lesson 2: Preparing for Regulatory Inspections
Lesson 3: Inspection Behavior
Lesson 4: Common Inspection Findings
Lesson 5: Responding to Regulatory Observations
Workshop: Mock GMP Inspection
Additional Module: Validation and Qualification
0/5
Lesson 1: Introduction to Validation and Qualification Validation Master Plan
Lesson 2 Equipment Qualification
Lesson 3: Process Validation
Lesson 4: Cleaning Validation
Workshop: Validation Case Study
Advanced Good Manufacturing Practice (GMP) for the Pharmaceutical Industry
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