Process Validation in Practice: From Protocol to Contiued Verification
This course simplifies process validation into logical, actionable phases aligned with EU GMP Annex 15 and FDA process validation guidance. It prepares QA, manufacturing, and technical staff to manage validation from protocol drafting through to ongoing verification and inspection defence.
Process validation is a cornerstone of GMP compliance — and a frequent cause of inspection findings when done poorly. Whether you’re releasing a new product, transferring a process, or verifying an existing one, regulators now expect a lifecycle approach to validation — not just three batches and done.
This 4-hour masterclass helps QA, validation leads, QPs and manufacturing teams design, execute and defend a process validation strategy from protocol through to continued process verification (CPV).
Course Details
Instructor
Paul Palmer
Level
Beginner
Duration
4 Hours
Type
Instructor led
Course Content
Why is this course essential?
Regulators no longer accept protocol templates with vague language, unjustified sample sizes, or post-hoc rationales. They expect validation to demonstrate process understanding, risk control, and ongoing review — all tied into your QMS.
What does the course cover?
- The three stages of validation: process design, qualification, and continued verification
- Drafting robust, audit-ready protocols with clear success criteria
- How to justify sampling plans and define acceptance limits based on risk and statistics
- Deviation management during validation: when to stop, when to investigate
- How to write a validation summary report (VSR) that supports batch release
- Building a CPV plan that’s realistic, data-driven, and inspection-resilient
- Tools for trending CQAs, critical parameters, and deviation recurrence
- Triggers for revalidation and lifecycle management updates
- Case studies from solid dosage, sterile, and biotech environments
- Templates for protocol authorship, VSR structure, CPV plans, and revalidation criteria
Ideal for?
- Manufacturing and packaging operators
- Warehouse and logistics staff
- Line leaders and team supervisors
- Junior QA and compliance professionals
- New hires or contractors in regulated environments
Benefits:
- Aligns fully with EU GMP Annex 15, FDA Process Validation guidance, and WHO lifecycle model
- Includes real-world tools and templates for protocol writing, CPV, and deviation capture
- Reduces rework, failed validations, and audit exposure
- Enhances team capability in defending validation strategy to inspectors and QPs
Keywords: GMP validation training, process validation course, EU Annex 15 training, CPV pharma training, validation summary report, QP validation training, FDA process validation lifecycle, sampling plan justification, revalidation triggers, audit-ready validation documents
What's Included
4hrs of instructor led learning
Usable documents and templates
Real work examples and exercises
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