Presented by
Management Forum
Process Validation with Qualification Training Course
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.
★★★★★ "Very pleased with the course, it was thorough and there was plenty of time for discussion and questi... more"
27-28 September 2023
from £1099
- Format: Live online
- 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
This course is part of our GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
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 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: Risk assessment
- Equipment and utility qualification: FDA PV Stage 2.1
- Exercise 5: Equipment Qualification
- Tools for Process Validation – part 1
- Tools for Process Validation – part 2
- Exercise 6: What techniques/ tools to use at which PV Stage
- Process Performance Qualification / Process Validation – FDA PV Stage 2.2
- Exercise 7: Process Validation - number of batches
- Continued Process Verification / Ongoing Process Verification – FDA PV Stage 3
- Exercise 8: Ongoing Process Verification
- Case Study: Process improvement
- Exercise 9: Continual Improvement
- Exercise 10: SWOT
Bruce Davis
Bruce Davis Ltd
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.
Book Process Validation with Qualification Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
27-28 September 2023
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 12338
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 23 Aug
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Reviews of IPI's Process Validation with Qualification training course
Very pleased with the course, it was thorough and there was plenty of time for discussion and questions.
Coming from a medical device background there was a lot of cross over which was helpful
Sep 26 2022
Rebecca Irving 
Engineer, Design Quality, CooperVision
Mar 14 2022
Very engaging with lots of examples to ease understanding.
Kirsty Brown
Scientist II, Thermo Fisher Scientific
Sep 26 2022
This course was extremely valuable for those initially dealing with Process validation and those who may have been performing validation and needed a broader understanding. The course covered all practical elements and approach
Jason Smit
Senior Production and Engineering Manager , CooperVision
Sep 26 2022
This course was extremely valuable for those initially dealing with Process validation and those who may have been performing validation and needed a broader understanding. The course covered all practical elements and approach
Jason Smit
Senior Production and Engineering Manager , CooperVision
Mar 14 2022
I learned a lot about Risk Qualification and Validation. It helps me understand my role in Facilities Qualification.
Morady Som 
Facilities Qualification , Cepheid
Sep 26 2022
Engaging and knowledgeable speaker.
John Cook
Quality Director, Theramex
Sep 21 2021
Very engaged and competent speaker.
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
Technical Director , 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
United Kingdom
- Allergan Biologics
- Associates of Cape Cod International Inc
- AstraZeneca
- AstraZeneca UK Ltd
- Catalent Pharma Solutions
- CooperVision
- Crescent Pharma Ltd
- Cyton Biosciences
- DCA Design International
- ECO Animal Health Group
- Evotec
- Fujifilm Diosynth Biotechnologies
- Gerard's Quality Solutions
- GW Pharmaceuticals
- GW Pharmaceuticals PLC
- Juniper Pharma Services Ltd
- LabMinds Ltd
- Life Technologies Ltd
- MHRA
- PCI Pharma services
- Penn Pharmaceutical Services Limited
- Piramal Pharma Solutions
- Porton Biopharma LTD
- Purolite Ltd
- Reckitt Benckiser
- STD Pharmaceutical Products Ltd
- Surgical Innovations
- Theramex
- Thermo Fisher Scientific
- Upperton Pharma Solutions
- Wesley Coe (Cambridge) Limited
Switzerland
- Actelion Pharmaceuticals Ltd
- Arcondis
- 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
United States of America
- Alkermes
- Cepheid
- Proveris Scientific Corporation
- Renaissance Lakewood LLC
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
Israel
- Medimop
- Perrigo API
Italy
- CHIESI FARMACEUTICI S P A
- Chiesi Farmaceutici S.p.a.
Austria
- Sandoz GmbH
Belgium
- Dentsply Implants NV
Finland
- INION OY
France
- Guerbet
Sweden
- Cepheid
Run Process Validation with Qualification Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
