Process Validation for Medical Device, Pharmaceutical, and Combination Product Manufacturing
This course will help you:
- Fully understand the regulatory requirements for process validation and their relationship to the Medical Device QSR and the Pharmaceutical cGMPs
- Gain knowledge to help manage a successful validation project
- Fully understand and successfully interpret the GHTF/SG3/N99-10:2004 Guidance on Process Validation
- Understand how to meet the new ISO-13485:2016 and ISO-9001:2015 validation requirements
- Understand other applicable guidance documents and standards such as ISO-14971:2012, ICH-Q9, and FDA’s Process Validation: General Principles and Practices – 2011
- Learn how to integrate design validation and process validation programs
- Understand how to setup and run a complete validation program and master validation plan
- Learn to write effective validation and qualification protocols
- Learn how to qualify the installation and operation of process equipment
- Learn to employ a risk based approach to process validation
- Understand the connection between validation and the change control system of a quality management system
- Learn how to determine critical process variables
- Learn the requirements for validation reports and process deviations
Course Details