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Process Validation with Qualification Training Course: face to face & live webinar

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.

22-23 Sep 2020

& 2-3 Mar 2021 , 21-22 Sep 2021

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 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

Programme - day 1

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 ONE: Guidelines

Process design: FDA Stage 1/EU Pharmaceutical development

EXERCISE TWO: Process design

Equipment and utility qualification: FDA Stage 2.1/EU Annex 15

EXERCISE THREE: Equipment qualification

Process performance qualification/process validation: FDA Stage 2.2/EU approaches

Programme - day 2

Quality risk management

EXERCISE FOUR: Process validation

Continued process verification/ ongoing process verification: FDA Stage 3/EU Annex 15

EXERCISE FIVE: Ongoing process verification

Continual improvement and process optimisation

EXERCISE SIX: Continual improvement

CASE STUDY: Process improvement

DISCUSSION: Implementation challenges

CASE STUDY: Continued/ongoing process verification

Presenter

Bruce Davis (More...)

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

  attend Face to face attend Live webinar
22-23 Sep 2020, Rembrandt Hotel, London
22-23 Sep 2020 Rembrandt Hotel, London GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 11 Aug*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 11 Aug*
Enrol now
to attend
Live webinar
2-3 Mar 2021, Venue not yet confirmed
2-3 Mar 2021 Venue not yet confirmed GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 19 Jan 21*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 19 Jan 21*
Enrol now
to attend
Live webinar
21-22 Sep 2021, Venue not yet confirmed
21-22 Sep 2021 Venue not yet confirmed GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 10 Aug 21*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 10 Aug 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Actelion Pharmaceuticals Ltd
  • Allergan Biologics
  • Ares Trading
  • Associates of Cape Cod International Inc.
  • AstraZeneca
  • AstraZeneca UK Ltd
  • Bayer AG
  • Bayer Consumer Care AG
  • Cepheid
  • Chiesi Farmaceutici S.p.a.
  • Cilatus BioPharma Consulting
  • Crescent Pharma Ltd
  • Cyton Biosciences
  • DCA Design International
  • Dentsply Implants NV
  • ECO Animal Health Group
  • F. Hoffmann-La Roche Ltd
  • GW Pharmaceuticals
  • Imtool Sarl
  • Intendis GmbH
  • Juniper Pharma Services
  • LabMinds Ltd
  • MHRA
  • Piramal Pharma Solutions
  • Proveris Scientific Corporation
  • Regeneron Pharmaceuticals
  • S T D PHARMACEUTICAL PRODUCTS LTD
  • Sandoz GmbH
  • SPP
  • Wesley Coe (Cambridge) Limited

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

A very good course, well presented and worthwhile attending.

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

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

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

Ian Lafferty, VP Technical Services, Juniper Pharma Services, Mar 18

Bruce was very engaging and good at conveying information.

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

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

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