Presented by
Management Forum
Process Validation with Qualification In-house Training
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.
★★★★★ "Webinar was excellent, very enjoyable and learned a lot of statistics."
- Format: Bespoke training
- CPD: 12 hours for your records (depending on your requirements)
- 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.
In today's pharmaceutical and biopharmaceutical industries, ensuring the reliability and efficiency of manufacturing processes is paramount. The need for rigorous process design, equipment qualification, and validation extends beyond mere compliance; it directly impacts product quality, patient safety, and regulatory adherence.
This comprehensive programme addresses these critical needs by taking a practical and analytical approach to process design, equipment, and utility qualification. It bridges the gap between product specifications and the meticulous verification required for equipment and processes at commercial scale.
Participants will delve into the foundational principles of Good Engineering Practice (GEP), essential for maintaining consistency and reliability throughout the manufacturing lifecycle. The course explores a range of advanced techniques, including Quality Risk Management (QRM), Design of Experiments (DoE), and statistical analysis. These methodologies are pivotal in optimising process qualification, verification, commissioning, and validation to achieve continual improvement and regulatory compliance.
Through expert guidance, attendees will learn how to apply these principles effectively, ensuring robust process design and validation strategies aligned with industry standards and best practices.
Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.
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
Professionals working in development, manufacturing, engineering and quality within the pharmaceutical and biopharmaceutical industry, including:
- 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
Reviews of IPI's Process Validation with Qualification training course
I really enjoyed this webinar. I will be recommending it to colleagues as a great source of information and introduction to process validation. The material was engaging, and [speakers'] knowledge/experience was communicated very well. I greatly enjoyed the content and presentation style. Topics were split up and presented in a logical order and the exercises were very helpful to reiterate the information that was presented.
May 20 2025
Brianna Boehm 
Process Validation Technical Writer, Aldevron
May 20 2025
The webinar is well constructed and the speaker is a very polite and prepared person. I managed to get the initial information needed to start studying and understanding the process validation program, the exercises [were] very helpful.
Alessandra Fanzini 
CDMO, REITHERA SRL
May 21 2024
Webinar was excellent, very enjoyable and learned a lot of statistics.
Siobhan Crowe 
Operation Manager, Univet Ltd
Jan 16 2024
The course was very informative and the speaker explained the content very well. I've also liked that all relevant guidelines have been included in the slides.
Laura Sukacz 
Quality Operations Officer, Kent Pharma UK Ltd
Jan 16 2024
The course was very informative and the speaker explained the content very well.
Laura Sukacz
Quality Operations Officer, Kent Pharma UK Ltd
Sep 26 2022
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
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
- Kent Pharma UK 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
United States of America
- Aldevron
- Alkermes
- Amway (UK) Ltd
- Cepheid
- Proveris Scientific Corporation
- Renaissance Lakewood LLC
Netherlands
- Biosynth B.V.
- Kinesis Pharma
- Merus NV
- SPP
- uniQure
Denmark
- Alk-Abelló A/S
- Alk-Abelló A/S
- Emendo Research & Development
- Fujifilm Diosynth Biotechnologies
Germany
- CSL Behring GmbH
- Intendis GmbH
- Merck Healthcare KGaA
- Sanofi-Aventis Deutschland GmbH
Ireland
- Cilatus BioPharma Consulting
- Cilatus Regulatory Services Ltd
- Regeneron Pharmaceuticals
- Univet Ltd
Italy
- CHIESI FARMACEUTICI S P A
- Chiesi Farmaceutici S.p.a.
- REITHERA SRL
Israel
- Medimop
- Perrigo API
Austria
- Sandoz GmbH
Belgium
- Dentsply Implants NV
Finland
- INION OY
France
- Guerbet
Sweden
- Cepheid
Run Process Validation with Qualification Bespoke training for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- 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:
