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HomepageBusiness ServicesTrainingManagement Systems TrainingISO 13485:2016Process Validation for Medical Device Manufacturing
Process Validation for Medical Device, Pharmaceutical, and Combination Product Manufacturing
Who Should Attend
- Those responsible for planning and operating a compliant validation program.
- Key players such as Process Engineers, Operations, Quality, and Regulatory personnel.
- R&D, Design Engineers and Product Formulators who translate product requirements into manufacturing requirements.
Course Details
• 3 Days
• 2.3 CTUs
• $2295
Course Objectives
- 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
Agenda
- Day One
8:00am to 5:00pm- Validation program barriers
- Terminology and definitions
- Regulatory perspective and requirements
- Basic concepts of process validation
- Elements of a Site Master Validation Plan
- Role of Risk Management in process validation
- Quality system and cGMP requirements
- Day Two
8:00am to 5:00pm- Process design
- Writing validation & qualification protocols
- Writing documented procedures for the validation program
- Writing an installation qualification protocol
- Writing and operation qualifcation protocol
- Dealing with deviations from approved protocols
- Day Three
8:00am to 5:00pm- Process Qualification & Process Performance Qualification
- Writing a Process Qualification Protocol
- Execution of Protocols
- Creating Validation Reports
- Documentation in the Validation Program
- Integration of Validation into the entire Quality Management System
- Tips on auditing a validation program