Presented by
Management Forum

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.

14-15 Mar 2022 + 2 more dates

Enrol now

  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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

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The Process Validation with Qualification course will cover:

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

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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), 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.

More details

Book Process Validation with Qualification Live online/Classroom training

14-15 Mar 2022

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
05:30-13:00 New York (UTC-04)
Course code 11586

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 07 Feb

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20-21 Jun 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11371

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 16 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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26-27 Sep 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11691

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 22 Aug

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Reviews of IPI's Process Validation with Qualification training course


Very engaged and competent speaker.

Sep 21 2021

Alis van der Aa Kühle
Delegated QP, Fujifilm Diosynth Biotechnologies

Mar 3 2020

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 3 2020

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

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

Mar 3 2020

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 6 2019

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 6 2019

A very good course, well presented and worthwhile attending.

Mark Hanford
Validation Specialist, PCI Pharma Services

Mar 6 2018

Bruce was very engaging and good at conveying information.

Ming Tong
Principal Protein Scientist, Piramal Pharma Solutions

Mar 6 2018

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

Ian Lafferty
VP Technical Services, Upperton Pharma Solutions

Mar 6 2018

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 6 2018

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

Oct 16 2017

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

Lorraine Wallace
QA Associate Manager, Fujifilm Diosynth Biotechnologies

Oct 16 2017

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

Andrew Betts
Site Quality Leader, Purolite Ltd

Oct 3 2016

Appropriate content and excellent speakers.

Marta Lopez Garcia
Senior Technical Manager, Bayer Consumer Care AG

UK

  • Allergan Biologics
  • Associates of Cape Cod International Inc
  • AstraZeneca
  • AstraZeneca UK Ltd
  • Catalent Pharma Solutions
  • Crescent Pharma Ltd
  • Cyton Biosciences
  • DCA Design International
  • ECO Animal Health Group
  • Evotec
  • Fujifilm Diosynth Biotechnologies
  • GW Pharmaceuticals
  • GW Pharmaceuticals PLC
  • Juniper Pharma Services Ltd
  • LabMinds Ltd
  • MHRA
  • PCI Pharma services
  • Penn Pharmaceutical Services Limited
  • Piramal Pharma Solutions
  • Porton Biopharma LTD
  • Purolite Ltd
  • Reckitt Benckiser
  • STD Pharmaceutical Products Ltd
  • Upperton Pharma Solutions
  • Wesley Coe (Cambridge) Limited

Switzerland

  • Actelion Pharmaceuticals Ltd
  • Bayer Consumer Care AG
  • F. Hoffmann-La Roche Ltd
  • Idorsia Pharmaceuticals Ltd.
  • Imtool Sarl
  • Janssen Cilag Farmaceutica
  • ObsEva SA
  • Sintetica SA

Germany

  • CSL Behring GmbH
  • Intendis GmbH
  • Merck Healthcare KGaA
  • Sanofi-Aventis Deutschland GmbH

Denmark

  • Alk-Abelló A/S
  • Alk-Abelló A/S
  • Fujifilm Diosynth Biotechnologies

Ireland

  • Cilatus BioPharma Consulting
  • Cilatus Regulatory Services Ltd
  • Regeneron Pharmaceuticals

Netherlands

  • Kinesis Pharma
  • Merus NV
  • SPP

United States of America

  • Alkermes
  • Proveris Scientific Corporation
  • Renaissance Lakewood LLC

Israel

  • Medimop
  • Perrigo API

Austria

  • Sandoz GmbH

Belgium

  • Dentsply Implants NV

Finland

  • INION OY

France

  • Guerbet

Italy

  • CHIESI FARMACEUTICI S P A

Sweden

  • Cepheid

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy