Module 1: Introduction to Pharmaceutical Quality Systems and Global Regulations

• Overview of quality assurance and regulatory compliance in pharmaceuticals

• International regulatory frameworks: FDA, EMA, WHO, PIC/S

• Quality culture and management responsibility in pharmaceutical operations

• Hands-on Exercise: Mapping global regulatory standards and compliance requirements

Module 2: Good Manufacturing Practice (GMP) Principles and Applications

• Core GMP concepts and documentation control

• Personnel hygiene, training, and contamination prevention

• Qualification and validation in manufacturing processes

• Hands-on Exercise: GMP inspection of a mock manufacturing facility

Module 3: Good Laboratory Practice (GLP) and Quality Control Systems

• GLP principles and laboratory accreditation requirements

• Equipment calibration, validation, and maintenance programs

• Analytical method validation and data integrity

• Hands-on Exercise: Conducting a GLP compliance audit of a QC laboratory

Module 4: Quality Management System (QMS) Design and Implementation

• ISO 9001 and ICH Q10 frameworks for quality management

• Document control, deviation management, and change control systems

• Risk-based quality management and process improvement

• Hands-on Exercise: Developing a QMS workflow for pharmaceutical production

Module 5: Pharmaceutical Validation and Qualification Processes

• Process validation, cleaning validation, and equipment qualification

• Validation Master Plan (VMP) and documentation requirements

• Performance qualification (PQ) and revalidation protocols

• Hands-on Exercise: Preparing a sample VMP and validation protocol

Module 6: Supplier and Contract Manufacturing Compliance

• Supplier qualification and auditing processes

• Quality agreements and third-party risk management

• Handling deviations, complaints, and non-conformances

• Hands-on Exercise: Conducting a mock supplier quality audit

Module 7: Regulatory Inspections and Audit Management

• Inspection readiness and conduct of regulatory audits

• Common findings and inspection deficiencies

• Post-inspection responses, CAPA development, and continuous improvement

• Hands-on Exercise: Simulating an FDA or EMA audit scenario

Module 8: Documentation and Record Management in Quality Systems

• Documentation best practices and data integrity (ALCOA+ principles)

• Electronic records and signatures (21 CFR Part 11 compliance)

• Retention, archiving, and traceability requirements

• Hands-on Exercise: Reviewing and correcting mock GMP documentation errors

Module 9: Pharmacovigilance and Post-Marketing Quality Surveillance

• Quality control beyond production: pharmacovigilance and product recall management

• Stability studies and adverse event reporting systems

• Post-approval change management and lifecycle monitoring

• Hands-on Exercise: Drafting a post-marketing quality surveillance plan

Module 10: Case Study – Integrated Quality and Regulatory Compliance System

• Building a harmonized quality and regulatory compliance framework

• Analyzing real-world compliance failure cases and lessons learned

• Developing CAPA and continuous improvement strategies

• Hands-on Exercise: Group project to design an integrated QA and compliance roadmap