Presented by
Management Forum
Process Validation with Qualification Training Course
A focused course on modern, lifecycle-based process validation and qualification. Learn how to design, qualify, and maintain manufacturing processes in a state of control using science- and risk-based approaches aligned with FDA, EU GMP Annex 15, MHRA, and WHO expectations - supporting compliant, efficient, right-first-time validation.
★★★★★ "Webinar was excellent, very enjoyable and learned a lot of statistics."
3-4 June 2026
+ 1-2 December 2026 »
from £1299
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
Ensure your manufacturing processes are validated from end to end using modern, science-based practices that meet today’s global regulatory standards. In an era where regulators treat validation as a lifecycle activity rather than a one-time exercise, this course provides comprehensive training on how to design, qualify, and maintain processes in a state of control.
Over two days, participants will learn to integrate process validation and equipment/facility qualification into a unified strategy, aligned with FDA’s 2011 Process Validation Guidance, EU GMP Annex 15, UK MHRA expectations, and WHO guidelines. The programme walks through each stage - from initial process design and scale-up (Stage 1), through Installation/Operational/Performance Qualification (IQ/OQ/PQ) and Process Performance Qualification (PPQ) (Stage 2), into ongoing Continued Process Verification (CPV) programs (Stage 3).
Emphasis is placed on a risk- and science-based approach: leveraging tools like Quality by Design (QbD), Design of Experiments (DOE), and Process Analytical Technology (PAT) to build quality into the process, and using data analytics to monitor performance. Participants will also learn how to handle re-validation when changes or transfers occur, and how to document validation activities to satisfy inspectors. This course ensures you can validate processes efficiently and right-first time, supporting both compliance and operational excellence.
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
By attending this course, you will:
- Implement Annex 15 / FDA lifecycle validation (Stage 1–3) beyond the obsolete “3-batch” model
- Demonstrate sustained state of control using PPQ + CPV + PQR/APR integration
- Align IQ/OQ/PQ with PPQ execution, meeting ISPE and PIC/S inspector expectations
- Apply ICH Q8/Q9 risk-based validation, defending CQAs, CPPs, and acceptance criteria
- Design inspection-ready PPQ protocols with statistical and scientific justification
- Operationalise CPV and SPC trending, a growing FDA/MHRA inspection focus
- Eliminate data integrity risk using ALCOA+ across validation records and systems
- Validate digital tools correctly (spreadsheets, PAT, MES) per GAMP 5 and Annex 11
- Adapt validation for modern manufacturing, including PAT, RTRT, and continuous processes
- Control change without revalidation overkill, aligning Annex 15 with ICH Q12 principles
Who should attend
This course is ideal for professionals involved in pharmaceutical and biopharmaceutical development, manufacturing, engineering and quality who need to design, execute or assess process validation and qualification activities, including:
- Validation Engineers and Specialists Scientists and development scientists
- Pharmacists involved in product and process development
- Quality Assurance professionals and quality managers
- Quality control managers and senior analysts
- Validation and Qualification Specialists/ Engineers
- Technology transfer and scale-up managers
- Risk management specialists
- Lean and operational excellence specialists
- Operations managers and production engineers
- Late-stage product and process development staff
- Regulatory Affairs Personnel (CMC)
This course will cover:
Validation fundamentals and execution
Module 1: Regulatory overview of validation
- EU GMP Annex 15 validation principles
- FDA Process Validation lifecycle (Stage 1/2/3)
- WHO TRS validation expectations (lifecycle approach)
- ICH Q8, Q9, Q10, Q11, Q12 – Overview and Implications
- FDA Vs Annex 15
Module 2: Stage 1 - Process design & risk assessment (practical application)
- QbD linkage: CQAs ↔ CPPs ↔ Control Strategy
- ICH Q9 risk tools: FMEA / risk ranking / worst case
- DOE-based parameter understanding (design space thinking)
Module 3: Stage 2.1 - qualification (IQ/OQ)
- URS → DQ → IQ/OQ traceability
- ISPE baseline approach (risk-based qualification philosophy)
- HVAC & Utilities qualification fundamentals (critical systems)
Exercise 1: Building an equipment qualification strategy
Module 4: Stage 2.2 - PPQ / PQ execution
- PPQ protocol essentials: acceptance criteria + rationale
- Sampling plan: locations, frequency, worst case challenge
- Statistical confidence: variability, capability, trending readiness
Module 5: Stage 3 - OPV / ongoing process verification
- OPV plan: critical metrics, alert/action limits
- SPC trending: control charts, shifts, drifts, signals
- APR/PQR integration: trend to governance escalation
Exercise 2: SWOT analysis of validation strategy
Advanced Topics and Maintaining Control
Module 6: Validation documentation & data integrity (ALCOA+)
- Validation Master Plan (VMP): Protocol writing: testable requirements + objective evidence
- Part 11 / Annex 11 considerations (e-records / audit trails)
- GAMP 5 alignment for validation systems support
Exercise 3: Designing an OPV system
Module 7: Advanced validation techniques
- Continuous manufacturing validation concepts
- PAT / RTRT readiness (sensor qualification + model validation)
- Cleaning validation: MACO, worst case, residue strategy
Module 8: Maintaining the validated state & change control
- Requalification vs revalidation triggers (risk-based decision)
- Tech transfer interfaces: gap analysis + comparability evidence
- Controlled change implementation
Module 9: Workshop - Validation Plan Build
- Define CQAs/CPPs + control strategy map
- PPQ design: batches, sampling, acceptance criteria
- CPV dashboard: KPIs, alert/action limits, escalation path
Exercise 4 : Change scenario: assess revalidation requirements
Module 10: Inspection readiness & lessons learned
- Inspector hot-spots: rationale, traceability, execution discipline
- Common findings: weak acceptance criteria, poor deviation handling
- Data integrity failure modes: gaps, backdating, missing raw data
Case Study: Building a sustainable ongoing verification programme
Paul Palmer
Paul R Palmer Ltd
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
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
3-4 June 2026
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 16897
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 29 Apr
- 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
1-2 December 2026
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 16898
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 27 Oct
- 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; and apply only when booking multiple delegates on the same date.
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 Live online 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:
