Process Validation and Qualification, Including Validation Methods

Process Validation and Qualification, Including Validation Methods is a course that provides practical training on process validation, equipment qualification, and analytical method validation in alignment with international regulatory guidelines from the FDA, EMA, and ICH.

Key Topics

• International regulatory requirements in the US, EU, and globally
• Validation life cycle stages
• Quality risk management and control strategy
• Equipment and utilities qualification
• Process validation and monitoring
• Analytical method validation
• Science- and risk-based approaches
• Determination of validation batches
• Product and manufacturing process requirements
• Maintaining product control over its life cycle

Who should Attend

• Scientists and engineers
• Process validation and qualification professionals
• Quality and manufacturing specialists
• Pharmaceutical development experts
• Engineering and validation team members
• Professionals from innovative, generic, and contract manufacturing companies