Process Validation

This course is designed to provide an overview of the latest concepts and guidance documents for Process Validation.

The US FDA and EMA have different approaches to Process Validation and understanding these approaches will provide your people with the best opportunity to develop and implement your own compliant validation approaches.

Course Duration & Location

3-5 days, on your site or at one of our training centers.

CiPharma’s training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You’ll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.

What you will learn

  • Understand a risk based validation strategy
  • Understand the US FDA’s three stages of Process Validation
  • Know the EMA’s approach to Process Validation
  • Understand the concepts of continued process verification
  • Understand how to establish and implement control strategies to maintain the validated state
  • Course materials

    Participants will receive a copy of the presentation(s), relevant notes and workshop materials.

    A certificate of completion will be issued to participants who successfully complete the assessment.

    Assessment

    A written assessment is conducted at the end of the course.

    Course Format

    The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

    Who should attend?

  • Quality Control personnel
  • Validation Managers
  • Validation Specialist
  • Operations or Manufacturing personnel
  • Engineering personnel