ExpiredProcess Validation & Statistics – Masterclass

Take full advantage of your time at the 2017 Engineering, GMP & Validation forum by continuing your learning and attending a Masterclass.

This course will be facilitated by Jacob MacDonald and Bernie Prendergast and held across 2 days:

Day 1 – Process Validation Training Course is designed to provide an overview of the latest concepts and guidance documents for Process Validation as issued by the EU and PIC/S PE 009 Annex 15 in October 2015, as well as the US FDA in 2011. The course will provide practical insights into how “modern process validation” is carried out and how to avoid common and costly mistakes.

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

Upon completion of this Process Validation Training you will;

  • Understand how to set a risk-based process validation strategy and build into your documentation validation efficiency
  • Clearly understand the expectations and how to comply with the US FDA three stage approach to Process Validation
  • Clearly understand the expectations and how to comply with the PIC/S and EU approach to Process Validation, i.e. Annex 15 Qualification and Validation
  • Understand the concepts of Continued Process Verification and Continuous Process Validation
  • Understand how to establish and implement control strategies to maintain the validated state.

Day 2 – Statistic are a fundamental part of GMP and all stages of process validation, as “understanding variation is the key to success in quality and business” (W. Edwards Deming).

We have developed an interactive course that will keep you engaged throughout the day as you develop a practical understanding through workshops and discussion of statistics in process validation including: understanding variability, statistical inference, Design of Experiments (DoE), control charts and more.

By the end of this course you will have a practical understanding of:

  • Flowcharts and process mapping
  • Basic statistical tools
  • Design of Experiments (DoE)
  • Statistical process Control
  • Problem-solving
  • Recording data so that it becomes valuable information.

Book for one day, or take advantage of the full course and come along for both.

  • Process Validation and Statistics - Masterclass (MEL-26/27-07-17)
    26 July 2017 - 27 July 2017
    9:00 am - 5:00 pm



Venue Phone: (+61) 3 9667 5800

Venue Website:

270 Collins Street, Melbourne, Victoria, 3000, Australia