Process Validation Training based on US FDA and EU – PIC/S GMPs

Process Validation Training Course Overview

This one-day Process Validation training course is designed to provide an overview of the latest concepts and guidance documents for Process Validation as issued by the FDA in 2011 and the EU, PIC/S Annex 15 in October 2015 and to provide practical insights into how “modern validation” is carried out and avoid common and costly mistakes.

The US FDA and EMA have different approaches to Process Validation, understanding these approaches will provide your team with the best opportunity to develop and implement your own compliant validation approaches, and of course manufacture or deliver safe products.

Course Duration & Location

One-day, on your site or at an offsite location.

PharmOut’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.


Our 2018 pricing is A$350 per person or A$3500 per day plus GST for up to 15 participants. This does not include travel costs.

*Smart device and WiFi is needed for all attendees.

Contact us for a quote if you need more that 10 trainees to be trained.

What you will learn

Upon completion of this Process Validation training course participants will;

  • Understand how to set a risk based validation strategy and build into your documentation validation efficiency
  • Clearly understand the expectations and how to comply with the US FDA’s three stages of Process Validation
  • Clearly understand the expectations and how to comply with the PIC/S and EU’s approach to Validation, i.e. Annex 15
  • Understand the concepts of continued process verification and continuous process validation
  • 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.


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
  • Operations or Manufacturing personnel
  • Engineering personnel
  • Validation Managers
  • Validation Engineers
  • Validation Specialists

More information

If you would like a quote or would need to ask questions, please contact us.

Public training courses and events

Register for Process Validation Training Course below:

If you need any assistance, would like a quote for personalised group training, or just have a general training question don’t hesitate to contact us.

Event Venue Date
Auckland Process Validation & Statistics for Process Validation Novotel Auckland Airport
  • 23/05/2019 9:00 am
Sold Out
Melbourne Process Validation Training Canterbury International Hotel
  • 12/06/2019 9:00 am
Sydney Process Validation Training Eden Gardens and Garden Centre - Sydney
  • 03/07/2019 9:00 am
Melbourne Process Validation Training Canterbury International Hotel
  • 10/07/2019 9:00 am