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Process Validation with Qualification

Gain a comprehensive understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, understand the link between QbD and process validation, apply relevant tools for process validation including risk assessment.

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Course overview

Attending this invaluable two-day event will give you the tools to fully understand and comply with current EU and FDA process validation guidelines and meet implementation challenges.

Taking a practical and analytical approach to process design, equipment and utility qualification, the programme will link product requirements to equipment verification and commercial-scale process validation.

Good engineering practice (GEP) and a range of techniques, including quality risk management and design of experiments
and statistics, will be examined to optimise continual improvement in process qualification, verification, commissioning and validation.

Benefits of attending:

  • Know the scope of FDA, EU and other international validation guidelines
  • Establish a three-stage, science and risk-based, life cycle process validation programme that can be applied to all products internationally, from generic products to novel medicines to ATMPs
  • Clarify similarities and differences between EU and US regulatory expectations
  • Understand the importance of a science and risk-based approach to support process validation and qualification
  • Realise significant business benefits by clarifying the key purposes of validation
  • Reduce validation documentation by concentrating on product drivers supported by clear qualification steps
  • Unscramble the real meaning of buzzwords such as qualification, verification and validation
  • Learn tools and techniques for you to subsequently apply to your products

Who should attend?

This seminar will be of particular interest to all those from the pharmaceutical industry working in::

  • Development
  • Manufacturing
  • Engineering
  • Quality

It will also benefit the following personnel working in the pharmaceutical and biopharmaceutical industry:

  • Process engineers
  • Pharmacists
  • Scientists
  • Quality assurance professionals
  • Quality control managers
  • Late-stage product and process development engineers, scientists, pharmacists
  • Technology scale-up and transfer managers
  • Validation and qualification managers
  • Validation and qualification specialists
  • Risk management specialists
  • Lean management specialists
  • Operations managers and engineers


The science and risk-based approach to process validation

ICH Q8/9/10/11/12

Exercise 1 – Key points

Introduction to the FDA process validation guidance

Introduction to the EU Process Validation Guidelines and Annex 15

Exercise 2: Guidances

Process design: FDA PV Stage 1

Exercise 3 : Process Design

Quality risk management

Exercise 4: Equipment Qualification

Equipment and utility qualification: FDA PV Stage 2.1

Tools for Process Validation – part 1

Tools for Process Validation – part 2

Exercise 5: What techniques/ tools to use at which PV Stage

Process Performance Qualification / Process Validation – FDA PV Stage 2.2

Exercise 6: Process Validation - number of batches

Continued Process Verification / Ongoing Process Verification – FDA PV Stage 3

Exercise 7: Ongoing Process Verification

Case Study: Process improvement

Exercise 8: Continual Improvement

Exercise 9: SWOT


Bruce Davis (More...)

Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Technology Transfer (TT), Quality Risk Management and other related topics. He has run many training events for companies both in the UK and internationally. He is past Chair of ISPE International Board of Directors. He led, co-lead or contributed to a number of their guidances for PV, QbD & TT and most recently has co-written one chapter on TT for ATMPs (i.e personalised medicines) . He is a professional engineer with many years’ experience in the pharmaceutical industry and a wide international knowledge. He previously worked at AstraZeneca, where his responsibilities included managing international engineering and leading changes to qualification practices. He is an established trainer and likes to engage with participants, to try to ensure the training experience is related to their particular requirements, and to bring in the importance of science and risk based thinking.


Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 14-15 Mar 2022
  • 20-21 Jun 2022
  • 26-27 Sep 2022

Book now

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Previous customers include...

  • FUJIFILM Diosynth Biotechnologies UK Limited
  • Alk-Abelló A/S
  • Allergan Biologics
  • Associates of Cape Cod International Inc.
  • AstraZeneca
  • AstraZeneca UK Ltd
  • Chiesi Farmaceutici S.p.a.
  • Cilatus BioPharma Consulting
  • Cilatus Regulatory Services Ltd
  • Crescent Pharma Ltd
  • DCA Design International
  • Fujifilm Diosynth Biotechnologies
  • Guerbet
  • GW Pharmaceuticals
  • Imtool Sarl
  • Intendis GmbH
  • Janssen Cilag Farmaceutica
  • Juniper Pharma Services Ltd
  • Kinesis Pharma
  • LabMinds Ltd
  • Medimop
  • MHRA
  • ObsEva SA
  • Perrigo API
  • Piramal Pharma Solutions
  • Proveris Scientific Corporation
  • Regeneron Pharmaceuticals
  • Sandoz GmbH
  • Sintetica SA

Very engaged and competent speaker.

Alis van der Aa Kühle, Delegated QP, Fujifilm Diosynth Biotechnologies, Sep 21

Very good! Great speaker, well prepared, huge knowledge.

Simone Tortoioli, Technical Project Leader Drug Substance, Idorsia Pharmaceuticals Ltd., Mar 20

Bruce was very engaging, he tailored the course to individual needs and allowed time for questioning to make the course content very relevant to our experience.

Emma Lennon, Senior Manager, Research & Development, GW Pharmaceuticals, Mar 20

Excellent speaker and allowed enough time to make the course personal to each requirement. Highly recommended

Jitinder Wilkhu, Product Development Lead, GW Pharmaceuticals PLC, Mar 20

A very good course, well presented and worthwhile attending.

Mark Hanford, Validation Specialist, PCI Pharma Services, Mar 19

Bruce was very knowledgeable regarding validation and had many real-life experiences that I really liked. It was also nice that the group was small which gave room for some good discussions. I enjoyed the two days' training – a lot of information was shared but Bruce managed to keep it on an interesting level.

Helena Sedlenieks, QA Manager Equipment Validation, Cepheid, Mar 19

I wanted to achieve an understanding of PV and I have gained more than I could have hoped.

Adele Millar, Product Support Officer, Porton Biopharma LTD, Mar 18

Excellent, will recommend that others attend or arrange an In-house course.

Ian Lafferty, VP Technical Services, Upperton Pharma Solutions, Mar 18

Bruce was very engaging and good at conveying information.

Ming Tong, Principal Protein Scientist, Piramal Pharma Solutions, Mar 18

It is a really interesting course with a lot of valuable information and the speaker presents the info in an effective way.

Nancy Almashni, Mar 18

Well-defined and appropriate discussions governed by industry experts. Great presentation and supporting documents.

Andrew Betts, Site Quality Leader, Purolite Ltd, Oct 17

Content very good with lots of examples and exercises to test understanding.

Lorraine Wallace, QA Associate Manager, Fujifilm Diosynth Biotechnologies, Oct 17

Appropriate content and excellent speakers.

Marta Lopez Garcia, Senior Technical Manager, Bayer Consumer Care AG, Oct 16