Pharmaceutical formulation and validation are core pillars of modern drug development and manufacturing. This course builds a solid foundation in dosage-form design alongside the validation of processes, cleaning methods, and packaging systems. You’ll learn current regulatory expectations, practical protocols, and real-world cases so you can contribute confidently to GMP environments.

Module 1: Introduction to Validation

• Principles and objectives of validation
• Why validation matters for safety, efficacy, and quality
• Regulatory expectations (FDA, EMA, Health Canada)

Module 2: Process & Cleaning Validation

Process Validation (Updated 2023)

• Stages: Process design, qualification, continued verification
• Protocol development and acceptance criteria
• Ongoing monitoring and data trending

Cleaning Validation (Updated 2023)

• Cross-contamination risks & residue limits (MACO)
• Sampling & analytical methods (swab/rinse, method validation)
• Documentation, change control, and audit readiness

Module 3: Advanced Validation Applications

Advanced Process Validation

• Risk-based approaches: QbD, PAT, critical quality attributes/parameters
• Lifecycle management and data integrity
• Digital validation systems and electronic records

Advanced Filling & Packaging Validation (Updated 2023)

• Validation of sterile/non-sterile filling lines
• Container-closure integrity testing (CCI)
• Environmental monitoring & packaging performance

Module 4: Pharmaceutical Formulation Technology

Dosage Forms, Manufacturing & Packaging (Updated 2023)

• Overview: solid, liquid, semi-solid, and injectable products
• Unit operations and GMP controls
• Packaging design, labeling, and compliance

Solid Dosage Formulation (Certificate Series)

• Preformulation, excipient selection, and compatibility
• Tablet & capsule technologies; granulation strategies
• Scale-up, tech transfer, and troubleshooting

Module 5: Case Studies & Applied Learning

• Inspection findings & regulatory warning letters—what went wrong
• Common pitfalls in formulation and validation
• Best practices and corrective/preventive actions (CAPA)

Module 6: Wrap-Up & Assessment

• Key takeaways and final review
• Quiz or mini-project (protocol/design exercise)
• Certificate of completion