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

3-4 Mar 2020

& 22-23 Sep 2020

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

Book now

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 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
  • Understand how Quality by Design supports process validation
  • Realise significant business benefits from taking a science and risk-based approach
  • Unscramble the real meaning of buzzwords such as qualification, verification and validation

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

Programme - Day one

The Science and Risk-Based Approach to Process Validation

ICH Q8/9/10/11

Introduction to the FDA Process Validation Guidance

Introduction to the EU Process Validation Guideline and Draft Annex 15


Exercise 1: Guidelines

Process Design: FDA Stage 1/EU Pharmaceutical Development

Exercise 2: Process Design

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

Exercise 3: Equipment Qualification

Feedback and Discussion

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

Programme - Day two

Introduction to Day Two

Quality Risk Management

Exercise 4: Process Validation

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

Exercise 5: Ongoing Process Verification

Continual Improvement and Process Optimisation

Exercise 6: Continual Improvement

Feedback and Discussion

Case Study: Process Improvement

Discussion: Implementation Challenges

Case Study: Continued/Ongoing Process Verification

Feedback and Discussion


Bruce Davis

Bruce Davis, Senior Consultant, Engineering, QbD and Qualification, Bruce Davis Global Consulting. Bruce is a professional engineer with 20 years’international experience of projects for drug substance and drug product manufacturing facilities. When he was with AstraZeneca, he led major changes to qualification processes globally as well as leading Quality by Design (QbD)cross-functional workshops for newproducts. He is ISPE’s former Chairman and Secretary to ASTM E55.03. For ISPE, he led the QbD case study, now published.

Book now

3-4 Mar 2020
3-4 Mar 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
22-23 Sep 2020
22-23 Sep 2020 Venue not yet confirmed GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Alk-Abelló A/S
  • AstraZeneca
  • Bayer AG
  • Cepheid
  • Chiesi Farmaceutici S.p.a.
  • Cilatus BioPharma Consulting
  • Cilatus Regulatory Services Ltd
  • Crescent Pharma Ltd
  • Cyton Biosciences
  • DCA Design International
  • Dentsply Implants NV
  • ECO Animal Health Group
  • F. Hoffmann-La Roche Ltd
  • Guerbet
  • GW Pharmaceuticals
  • Idorsia Pharmaceuticals Ltd.
  • Intendis GmbH
  • Juniper Pharma Services
  • Juniper Pharma Services Ltd
  • Kinesis Pharma
  • Medimop
  • MHRA
  • ObsEva SA
  • Perrigo API
  • Piramal Pharma Solutions
  • Porton Biopharma LTD
  • Reckitt Benckiser
  • Wesley Coe (Cambridge) Limited

Overall opinion is a very good course following the title, well presented and worthwhile attending.

Mark Hanford, Validation Specialist, PCI Pharma Services

Bruce was very knowledgeable regarding validation and had many real-Life experiences- really liked that. 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

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

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 good

Adele Millar, Product Support Officer, Porton Biopharma LTD

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

Ian Lafferty, VP Technical Services, Juniper Pharma Services

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

Lorraine Wallace, QA Associate Manager, Fujifilm Diosynth Biotechnologies

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

Andrew Betts, Site Quality Leader, Purolite Ltd

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

Content appropriated and excellent speakers

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