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Reduce the cost of validation and time-to-market of innovative products while ensuring product quality and patient safety by using risk-based approaches to validation. Review risk-based approaches as defined by the industry and regulatory organizations, their use and application, as well as ensuring a successful, safe, and compliant outcome.
This 2 day, 16 hour course, covers the following topics:
- Validation review and terminology
- DQ, IQ, OQ, PQ, PV (PPQ)
- Quality Risk Management; ICH Q9
- Risk-Based approaches
- Failure Modes Effects Analysis (FMEA)
- Application of Risk based Validation
- Developing validation strategies
- Types of validation: Equipment, Cleaning, Computer, Sterilization and Process validation
- Risk based approach for validation of a new facilities
- Validation considerations for equipment and processes
Upon successful completion, participants will be able to:
- Understand the definition of Risk-based approaches and the industry/regulatory background for their use
- Apply risk-based approaches to equipment commissioning and qualification, sterilization, cleaning, and process validation in a compliant manner.
- Gain an understanding of how to use an FMEA to evaluate risks within a manufacturing process
This course is designed for individuals seeking an understanding of industry and regulatory agency drivers for risk-based validation including bioprocess engineers, technicians and operators, Quality Assurance, Quality Control, compliance and regulatory personnel who have validation responsibilities.