Course Description
The Medical Device and Pharmaceutical industries share the common goal of bringing safe and effective products to market as quickly and efficiently as possible. Process Validation is a formal methodology that allows companies to manufacture products on approved and qualified equipment, with a defined process leading to products that consistently meet predetermined specifications and quality requirements. This course provides an understanding of the regulatory requirements for process validation and their relationship to the Medical Device QSR and the Pharmaceutical cGMPs, and prepares participants to plan and operate a compliant validation program.
Who Should Attend
This course is designed for individuals responsible for planning and operating a compliant validation program, including:
- 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.
Learning Objectives
Through training, participants will:
- 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 Outline
Day One
- 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
- Process Design
- Writing Validation & Qualification Protocols
- Writing Documented Procedures for the Validation Program
- Writing an Installation Qualification Protocol
- Writing an Operation Qualification Protocol
- Dealing with Deviations from approved protocols
Day Three
- 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.
Prerequisites
None
Course Format
24 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
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