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

Have questions? Contact us

DEKRA Audits

8990 Springbrook Dr. NW

Suite 210

Minneapolis , MN 55443

+1 800.633.2588
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