Risk Based Approaches to Validation

Risk Based Approaches to Validation

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 course may be taught at any location.

Level: Advanced
Lecture Hours: 16.00
Lab Hours: 0.00
Total Contact Hours: 16.00

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Topics Include

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

Learning Objectives

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.