Process Validation with Qualification

Gain a comprehensive understanding of the EU and FDA Process Validation Guidance, how to establish a Process Validation Programme, understand the link between quality by design and process validation, apply relevant tools for process validation including risk assessment

16-17 Oct 2018

& 6-7 Mar 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course Overview

The two-day process validation in the US and EU, balancing science and risk during the product lifecycle meeting will help you gain an understanding of the EU and FDA process validation guidance, learn how to establish a process validation programme, under the link between Quality by Design and process validation as well as how to apply relevant tools for process validation including risk assessment.

Benefits in attending

Benefits in attending:

  • Know the scope of the FDA and EU validation guidelines
  • Establish a three stage, science-and-risk-based, lifecycle process validation programme
  • Clarify similarities and differences between EU and US expectations, with consideration of differing company requirements eg innovative to generic manufacturers
  • Understand how Quality by Design supports process validation
  • Link product requirements, to equipment verification to commercial scale process validation
  • Gain knowledge in qualification including Good Engineering Practice (GEP)
  • Apply tools such as Quality Risk Management, Design of Experiments and Statistics
  • Unscramble the real meaning of ‘buzz words’ such as qualification, verification, commissioning, calidation etc.
  • Realise significant business benefits from taking a science and risk-based approach

Who should attend

This seminar will be of particular interest to all those from the Pharmaceutical Industry working in:

  • Development
  • Manufacturing
  • Engineering
  • Quality

Personnel from the pharmaceutical and biopharmaceutical industry with the following background:

  • 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

Programme - Day one

09.00 Registration and coffee

09.30 Welcome and Introduction

10.00 The Science and Risk-Based Approach to Process Validation

10.30 ICH Q8/9/10/11

11.20 Introduction to the FDA Process Validation Guidance

11.50 Introduction to the EU Process Validation Guideline and Draft Annex 15

12.20 Discussion

12.30 Lunch

13.30 Exercise 1: Guidelines

13.50 Process Design: FDA Stage 1/EU Pharmaceutical Development

14.20 Exercise 2: Process Design

14.50 Equipment & Utility Qualification: FDA Stage 2.1/EU Annex 15

15.20 Refreshments

15.35 Exercise 3: Equipment Qualification

16.10 Feedback and Discussion

16.25 Process Performance Qualification/Process Validation: FDA Stage 2.2/EU approaches

17.00 End of Day One

Programme - Day two

09.00 Introduction to Day Two

09.15 Quality Risk Management

09.45 Exercise 4: Process Validation

10.45 Refreshments

11.05 Continued Process Validation/Ongoing Process Verification: FDA Stage 3/EU Annex 15

11.35 Exercise 5: Ongoing Process Verification

12.05 Continual Improvement and Process Optimisation

12.30 Lunch

13.30 Exercise 6: Continual Improvement

14.30 Feedback and Discussion

15.00 Case Study: Process Improvement

15.30 Refreshments

15.45 Discussion: Implementation Challenges

16.00 Case Study: Continued/Ongoing Process Verification

16.30 Feedback and Discussion

16.45 End of Seminar


Bruce Davis

Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Quality Risk Management, GMP for Engineers and other related topics. He has run many training events for companies both in the UK and internationally and is often invited to speak at international conferences. He is past Chair of ISPE International Board of Directors and led their case study for practical implementation of QbD. He co-chaired the team updating their Technology Transfer (TT) Guide and carries out training for them and other organisations. He is a professional engineer and has many years’ experience in the pharmaceutical industry and a wide international knowledge, and understanding of current regulatory approaches in the above topics for both US and EU. He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, facilitating QbD and leading changes to qualification practices. He played a leadership role to set up De Montfort University’s MSc distance learning course in QbD. He is an Associate to NSF Healthsciences, and for them has carried out consultancy and training in the above topic areas, and also for driving down human error.

Book now

16-17 Oct 2018
16-17 Oct 2018 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
6-7 Mar 2019
6-7 Mar 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Actelion Pharmaceuticals Ltd
  • Alk-Abelló A/S
  • Alkermes
  • Allergan Biologics
  • Associates of Cape Cod International Inc.
  • AstraZeneca
  • AstraZeneca UK Ltd
  • Bayer Consumer Care AG
  • Catalent
  • Chiesi Farmaceutici S.p.a.
  • Crescent Pharma Ltd
  • CSL Behring GmbH
  • DCA Design International
  • ECO Animal Health Group
  • Guerbet
  • GW Pharmaceuticals
  • Imtool Sarl
  • Juniper Pharma Services Ltd
  • Kinesis Pharma
  • LabMinds Ltd
  • Medimop
  • Merus NV
  • ObsEva SA
  • Perrigo API
  • Piramal Pharma Solutions
  • Proveris Scientific Corporation
  • Purolite Ltd
  • Sandoz GmbH
  • Wesley Coe (Cambridge) Limited

Excellent, will recommend other attend or arrange In-house course

Ian Lafferty, VP Technical Services, Juniper Pharma Services

Very good

Adele Millar, Product Support Officer, Porton Biopharma LTD

It is a really interesting course with a lot of valuable information and the speaker has a very good way of presenting the info in effective way

Nancy Almashni, ,

Very informative and engaging. Also valuable the additional inputs with regards to regulatory expectations which may not be apparent just from reading guidances.

Ming Tong, Principal Protein Scientist, Piramal Pharma Solutions

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

Andrew Betts, Site Quality Leader, Purolite Ltd

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

Lorraine Wallace, QA Associate Manager, Fujifilm Diosynth Biotechnologies

Content appropriated and excellent speakers

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

The course had aspects that were useful - but the overall content was not really applicable to my role. This was obvious within the first five minutes of the Day 1 when we reviewed objectives. As stated above, maybe this was a misinterpretation of course content

Anna Owens, Quality Assurance Manager, Associates of Cape Cod International Inc