Process Validation with Qualification In-house Training

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.

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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:

Day 1
Day 2

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.

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