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