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Practitioner training · Good practice (GxP)
FDA Process Validation Training: Validate Processes and Qualify Equipment
If you have a new line to bring into commercial use for the US market, a PPQ protocol to write, or a Form FDA 483 that says your process was never properly validated, FDA process validation training shows you what FDA expects at each stage. The common sticking points: how many PPQ batches are enough, what qualification of a new tablet press must prove, how to sample a coating step, and what continued process verification looks like once the protocol is signed.
This training course takes you through 21 CFR Part 211 and FDA's January 2011 process validation guidance: the three-stage life cycle, process design and control strategy, qualification of facilities, utilities, equipment and automated systems, process performance qualification protocols and reports, continued process verification with statistical trending, and change control. You follow one built project, a new metformin tablet line at JKL Pharma's Mumbai site supplying the US, from design to annual review.
FDA process validation training teaches how to validate drug manufacturing processes to US requirements: the CGMP rules in 21 CFR Part 211 and FDA's 2011 guidance with its three stages of process design, process qualification and continued process verification, plus the qualification of facilities, utilities and equipment, PPQ protocols and reports, and change control.
Training a validation team? Get a quote for your organisation
Part of: Pharmaceutical GMP and GDP Training
Part of: GMP & Medical Devices
Secure payment by Stripe · for yourself or for your team
What you get
- 12 video modules
About 3 hours, with captions. Watch at your own pace on any device.
- Practice after every module
Short questions check your understanding before you move on.
- Final exam
Multiple choice, with immediate retakes if you need them.
- Built by experts
Industry experts, domain specialist trainers and globally renowned auditors with 30+ years in ISO and GRC.
A certificate you can prove, and share
Verifiable certificate with a QR code anyone can scan, plus a digital badge to add to your LinkedIn profile.
See how verification works →Standard and edition21 CFR Parts 210 and 211; FDA Process Validation guidance (2011)
Last updated31 October 2026
Why FDA process validation training matters now
FDA keeps finding processes that were never shown to work. In December 2025 FDA wrote to an over-the-counter manufacturer in New York State whose process validation was inadequate for products including those for infants and children; validation records lacked predefined critical steps, and the findings repeated a 2019 letter. The same month, a Florida OTC manufacturer was cited because its 2017 validation excluded filling and packaging, its batch size had changed, and its water system was not validated.
In June 2026 FDA's animal drug centre wrote to a Kentucky manufacturer whose equipment was not qualified and whose process was not validated before commercial lots were released. FDA stated plainly that merely purchasing measurement instruments does not constitute equipment qualification, and that testing finished product is not process validation. Validation is evidence gathered across the life of a process, not a one-off set of batches.
Who this FDA process validation training course is for
The course is for people who design, qualify, validate or approve manufacturing processes for drug products supplied to the US. Take it when you start in a validation role, when a new line or product is coming, before an FDA pre-approval or routine inspection, after a finding on validation or qualification, or when a technology transfer lands on your desk.
- Validation, quality assurance and quality control staff
- Production and engineering managers
- Technical services and technology transfer teams
- Consultants working with drug products made for the US market
What you will learn on this training course
The outcomes follow the three stages of the life cycle, with equipment qualification in the middle where FDA's guidance places it.
- Explain the CGMP requirements for process validation and FDA's three-stage life cycle
- Turn development knowledge into a documented process design and control strategy
- Plan and carry out the qualification of facilities, utilities and equipment
- Write a process performance qualification protocol and report with a sound sampling plan
- Set up continued process verification with statistical trending and annual review
- Assess changes and keep processes and equipment in a validated state
Course outline: 12 modules
- Module 1, Why process validation matters: three recent FDA warning letters, what validation means, and the built company.
- Module 2, The CGMP basis in Part 211: the statute, the Part 211 sections behind validation, the quality unit and FDA guidance.
- Module 3, The life cycle and variation: FDA's definition, the three stages, variation, criticality, the team and legacy products.
- Module 4, Stage 1, process design: building process knowledge, experiments and models, and the control strategy.
- Module 5, Facility and equipment requirements: Part 211 equipment rules, FDA's qualification activities, terms and the plan.
- Module 6, Qualifying equipment: verifying the build, calibration, operation under load, failures and the report.
- Module 7, Utilities, automation and methods: water and air, other utilities, automated systems under 211.68 and validated methods.
- Module 8, Process performance qualification: what PPQ is, how many batches, the protocol, sampling and heightened monitoring.
- Module 9, Running PPQ and the report: readiness checks, departures, the report and its conclusion, and concurrent release.
- Module 10, Continued process verification: data to collect, statistical trending, signals and annual review.
- Module 11, Change, maintenance and requalification: planned changes, regulatory questions, suppliers and investigations.
- Module 12, Putting it together at JKL Pharma: the full case, a road map and checklist, and key takeaways.
The FDA process validation requirements explained
The legal requirements sit in 21 CFR Part 211, for example 211.100 on written procedures for production and process controls, 211.110 on in-process controls, 211.63 to 211.68 on equipment and automated systems, and 211.180 on annual review. FDA's guidance Process Validation: General Principles and Practices (January 2011, Revision 1) explains how to meet them through a life cycle of three stages: Stage 1, process design; Stage 2, process qualification, including qualification of the facility, utilities and equipment and process performance qualification; and Stage 3, continued process verification.
The course is clear about what is law and what is recommendation: regulations are taught as requirements, and the guidance and FDA's questions and answers as FDA's recommendations. FDA's Q&A states there is no fixed minimum number of PPQ batches. The terms IQ, OQ and PQ are industry terms; the guidance describes the qualification activities without them, and the course maps one to the other.
How the online course works
The course is delivered as 12 on-demand video modules with about 3 hours of video in total. Each module ends with short practice questions so you can check your understanding before moving on; they do not count toward your result. Four practice exercises with model answers apply each stage: a qualification test plan for a fluid-bed dryer, a PPQ sampling plan for a coating step and finished tablets, a continued process verification plan, and a change assessment for a second supplier of the active ingredient.
The course closes with a multiple-choice final exam drawn from the course's question bank. A score of 60% or more meets the criteria for the certificate. If the first attempt does not meet the criteria, one retake is included. You receive a Sterling Academy Certificate of Competence when the exam criteria are met.
- Study online, on demand, on any device: laptop, tablet or phone
- Learn at your own pace and replay any module
- Practice questions after every module
- Final multiple-choice exam with one retake
- Certificate of Competence when the exam criteria are met
What you can do after the course
You will be able to plan and defend validation work on your own products.
- Write a validation master plan that covers all three stages
- Plan the qualification of a new press, dryer or utility extension
- Justify the number of PPQ batches and the sampling plan in the protocol
- Write a PPQ report with a clear conclusion on the state of control
- Set up statistical trending for continued process verification and annual review
- Assess a change and decide what requalification or revalidation it needs
- Explain to colleagues why finished-product testing alone is not validation
FDA process validation training for teams and organisations
Sterling Academy offers company plans so a whole team can take this course together. A client administrator in your organisation adds people, assigns this course and related ones, and follows progress from one place, so validation, QA, QC, production and engineering staff can all work from the same method.
Progress reports show who has started, who has completed and who holds a certificate, which is useful evidence of training when an auditor or inspector asks for it. Your organisation receives one invoice for the plan instead of individual receipts. Company prices are set per organisation: get a quote for your organisation and we will reply with a plan that fits the number of learners and courses you need.
Why learn with Sterling Academy
Sterling Academy courses are built by industry experts, domain specialist trainers and globally renowned auditors with 30+ years of experience in ISO and GRC. The Academy is the training arm of Sterling International Consulting, with 8,100+ client engagements in 60+ countries over 20+ years, so the course content reflects what auditors, inspectors and clients actually ask for in practice.
Every course is kept to the current text of the regulations and guidance it teaches; this one uses the eCFR text of Part 211, FDA's 2011 guidance and FDA questions and answers current as of May 2026.
Preview this course
Experience the learning
before you enrol.
Watch a sample from Process Validation and Equipment Qualification (US FDA) before you enrol.
Process Validation and Equipment Qualification (US FDA)Sample
Inside the course
A clear path through the essentials.
12 modules, 12 practice checkpoints, 4 practice exercises and a final exam. Video runtimes are approximate; allow additional time for the practice questions and the final exam. Modules marked optional can be skipped; the others are studied in any order.
Part 1Part A: Why process validation matters and the Part 211 basisApprox. 28 min
- Why process validation matters12 min
Why FDA process validation and equipment qualification matter, shown through three recent FDA warning letters, and how the course follows one tablet line.
What this module covers
Starts with a question: how do you know tomorrow's batch will be as good as today's? After a self-rating, three recent FDA warning letters follow, including one in June 2026 to an animal drug maker in Kentucky, with validation records that did not predefine critical steps and batch records missing component lots and equipment identification. You then learn what process validation means: building quality in and showing with data that the process is consistent, since a few samples cannot show what happened to every tablet. You meet JKL Pharma's oral solid dose site in Mumbai, installing a new metformin tablet line with a granulator, dryer, press and coater, plus a biologics maker in Boston and a contract manufacturer in Dublin. It ends with the course structure and a recap.
What you will be able to do
- Explain what process validation means under FDA expectations
- Recognise the validation failures behind three recent FDA letters
- Describe the roles of validation teams and the quality unit
Why it matters
Seeing how weak validation led to warning letters shows why quality must be built in and shown with data, not hoped for.
Practice: Practice: Why process validation matters · 3 questions
- The CGMP basis in Part 21115 min
Covers the US CGMP legal basis for process validation: FD&C Act section 501, 21 CFR 211.100, 211.110, 211.160, 211.165 and 211.180, and the quality unit.
What this module covers
Opens with two quality managers reading the same FDA guidance: one at an over-the-counter medicines maker in New York treats ongoing monitoring as optional because of the word should, the other at a biologics maker in Boston does not. You then learn that under section 501 of the Act a drug made without CGMP controls is adulterated, even if it tests well, as all three Module 1 letters concluded. The module walks the Part 211 sections that require validation, written procedures for production and process control, in-process specifications from process averages and variability, and equipment requirements. It explains the quality unit's approval role and how to read FDA guidance. A generic injectables maker in Toronto and JKL's own duty and record map show the practice. It ends with a recap.
What you will be able to do
- Explain why process validation is a legal requirement in the US
- Identify the Part 211 sections that require validation
- Map each requirement to an owner and a record
Why it matters
Knowing that the regulation, not the guidance, is the requirement stops sites treating ongoing monitoring as optional.
Practice: Practice: The CGMP basis in Part 211 · 3 questions
Part 2Part B: The life cycle, qualification, PPQ, verification and changeApprox. 180 min
- The life cycle and variation15 min
Explains FDA's 2011 process validation guidance definition, the three-stage life cycle and how to understand, detect and control variation.
What this module covers
Starts with two batches of metformin tablets from JKL Pharma's older line: one released 92% at 30 minutes in dissolution, the other 81%, dried on a humid monsoon afternoon, and both met specification. You then learn FDA's definition of process validation from its 2011 guidance: data collected and evaluated from design through commercial production. The module explains the three stages, process design, process qualification and continued process verification, and the four things FDA expects about variation: understand its sources, detect it, understand its impact and control it in proportion to risk. It covers critical and non-critical terms, risk-based decisions with reasons recorded, and a contract manufacturer in Dublin. It ends with the common mistake of treating validation as a project with an end date, and a recap.
What you will be able to do
- Explain FDA's definition of process validation
- Describe the three stages of the validation life cycle
- Apply the four expectations for managing process variation
Why it matters
Understanding where variation comes from lets you catch drift before a batch fails, not just confirm three good days.
Practice: Practice: The life cycle and variation · 3 questions
- Stage 1: process design15 min
Covers FDA process validation Stage 1 process design: process knowledge, design of experiments, the control strategy and the draft master record.
What this module covers
Opens with JKL Pharma's development team moving the metformin granulation to a bigger mixer, where six minutes that worked on a 5 kilogram laboratory batch did not work on a trial at scale. You then learn FDA's definition of process design and the inputs product development supplies: the dosage form, quality attributes and a manufacturing pathway. The module explains building process knowledge through studies, risk-based screening and designed experiments, with models whose limits you understand, and a biologics maker in Boston that lives with variability every day. You see JKL's draft control strategy after the Stage 1 studies, using material examination and equipment monitoring. It ends with the Stage 1 outputs, the rationale, process flow diagram and draft master production and control record, and a recap.
What you will be able to do
- Plan Stage 1 studies that build real process knowledge
- Write a control strategy that reduces or adjusts for variation
- Prepare the Stage 1 outputs that carry forward to Stage 2
Why it matters
Designing for the line you will actually run avoids qualifying a process that only worked in the laboratory.
Practice: Practice: Stage 1: process design · 3 questions
- Facility and equipment requirements15 min
Explains Part 211 facility and equipment requirements for process validation, and how FDA guidance turns them into an equipment qualification plan.
What this module covers
Starts with an over-the-counter tablet maker in Sydney that bought a used tablet press at half price to launch quickly, then found worn tooling, unknown product-contact seals and other questions. You then learn what Part 211 requires: suitable design and size, safe contact materials, cleaning and maintenance, calibration under a written programme with records, and equipment identification. The module explains FDA's description of qualification: selecting equipment, verifying its build and verifying its operation in all ranges under load. You see the plan for JKL's Press 4, which directly shapes tablet weight, hardness and dose, with tests taken from Stage 1, including running under load with placebo granules and stops and restarts. It ends with plan contents, quality unit approval and a recap.
What you will be able to do
- Explain what Part 211 requires of buildings and equipment
- Write an equipment qualification plan with tests and criteria
- Take qualification tests from what Stage 1 learned
Why it matters
Showing suitability for your own product and use catches problems a supplier's brand name will never reveal.
Practice: Practice: Facility and equipment requirements · 3 questions
- Qualifying equipment14 min
Covers equipment qualification in practice: installation verification, calibration under 21 CFR 211.160, operation under load and the qualification report.
What this module covers
Returns to the Kentucky case, where the firm offered newly bought instruments as qualification and FDA replied that purchasing measurement instruments does not constitute qualification. You then learn to verify the build: materials, capacity, functions, connections and instruments calibrated under a written programme, with section 211.160 detail for laboratory instruments. The module explains verifying operation across all anticipated ranges, under load, with stops, restarts and interventions, shown at a packaging site in Hong Kong packing blisters for US customers. It covers handling unexpected observations and nonconformances, the qualification report signed against the approved plan, executed checklists with raw data, and JKL's green status label on Press 4. It ends with keeping the qualified state through maintenance, calibration and periodic review, and a recap.
What you will be able to do
- Verify equipment installation and calibration against the plan
- Test equipment operation across all ranges under load
- Write a qualification report that discusses every nonconformance
Why it matters
Qualifying a machine the way production will use it shows it really works, instead of filing paperwork FDA will reject.
Practice: Practice: Qualifying equipment · 3 questions
- Practice exercise: Qualification test plan for JKL's fluid-bed dryerabout 12 min
- Utilities, automation and methods14 min
Explains qualifying utilities such as purified water and air, 21 CFR 211.68 controls for automated systems, and validated analytical methods (ICH Q2(R2)).
What this module covers
Opens with the Florida case from Module 1, where a firm had not validated its water system, was not testing for a group of bacteria FDA named, and used a microbial limit that did not match its certificates. You then learn that utilities such as water and air are qualified like equipment, each with its own plan, tests and report, and run under normal conditions during process performance qualification. The module explains section 211.68 for automated systems: authorised changes, checked input and output, secure backups with tested restores, and checks on automated steps. It covers validated and verified release methods, ICH Q2(R2) issued as FDA guidance in March 2024, and a contract testing laboratory in London. It ends with the records, monitoring data and a recap.
What you will be able to do
- Plan qualification and monitoring for water and air utilities
- Explain the section 211.68 controls for automated systems
- Check that every release method is validated or verified
Why it matters
Qualifying everything that touches the product closes gaps that equipment qualification alone leaves open.
Practice: Practice: Utilities, automation and methods · 3 questions
- Process performance qualification14 min
Covers FDA process performance qualification (PPQ): what PPQ is, how many batches, the PPQ protocol and statistical sampling plans.
What this module covers
Starts with the New York case from Module 1, where validation records did not predefine critical steps such as handling a bulk suspension during filling, and batch records lacked component lots. You then learn what process performance qualification combines: the qualified facility, utilities and equipment, trained people and the commercial process, and that it must succeed before distribution. The module explains why FDA sets no minimum number of batches, and you see JKL Pharma build a science-based rationale for its metformin tablets, while a biologics maker in Boston decides differently. It covers the protocol's conditions, tests and criteria, sampling with statistical confidence within and between batches, why the uniformity chapter is not a sampling plan, and handling an out-of-specification result. It ends with a practice exercise and a recap.
What you will be able to do
- Explain what process performance qualification must show
- Justify the number of PPQ batches with a science-based rationale
- Write a PPQ protocol with a statistically sound sampling plan
Why it matters
A sound rationale and sampling plan replace the habit of three batches with evidence an investigator will accept.
Practice: Practice: Process performance qualification · 3 questions
- Practice exercise: PPQ sampling plan for JKL's coating step and finished tabletsabout 15 min
- Running PPQ and the report14 min
Explains running PPQ batches under normal conditions, handling departures, writing the PPQ report and when concurrent release is justified.
What this module covers
Returns to the Kentucky letter, where testing already released lots was offered as validation and FDA called it scientifically flawed and unacceptable. You then learn that PPQ starts only after protocol approval, with batches made the routine way by routine personnel, and departures approved or investigated. The module explains the report: analysing all the data, discussing every deviation, describing corrective actions and changes to procedures, and stating a clear, justified conclusion approved by the quality unit. You see JKL release its three batches only after the report is approved and each batch passes normal review under section 211.192. A generic injectables maker in Toronto shows concurrent release, rare, justified in the protocol and backed by close oversight. It ends with a recap.
What you will be able to do
- Run PPQ batches under routine conditions and procedures
- Write a PPQ report with a justified conclusion
- Explain when concurrent release is justified
Why it matters
Reporting what happened before deciding gives a validation conclusion that stands up to inspection.
Practice: Practice: Running PPQ and the report · 3 questions
- Continued process verification14 min
Covers FDA Stage 3 continued process verification (CPV): data collection, statistical trending, signals, and the annual product review under 211.180.
What this module covers
Opens with JKL Pharma's older tablet line, where every batch met in-process hardness limits for six months while a batch-by-batch chart showed hardness falling as punches wore. You then learn that Stage 3 gives continual assurance through an ongoing programme required by section 211.180, with records used to evaluate each product at least annually. The module explains what data to collect on inputs, process and outputs, trending within and between batches with rules designed by someone trained in statistics, and using complaints and adverse event reports. A liquid medicines maker in New York shows how to start. You see JKL's first annual product review for the metformin tablets, with weight and hardness reviewed weekly. It ends with how signals trigger investigation and action, and a recap.
What you will be able to do
- Plan continued process verification data on inputs and outputs
- Trend data statistically within and between batches
- Use the annual product review to decide on process changes
Why it matters
Trending as you go gives an early warning of drift long before a complaint or the annual review.
Practice: Practice: Continued process verification · 3 questions
- Practice exercise: Continued process verification plan for JKL's coating stepabout 12 min
- Change, maintenance, requalification14 min
Explains change control for a validated process, supplier and material changes, and maintenance, calibration and requalification of equipment.
What this module covers
Returns to the Florida case, where process validation from 2017 no longer described a process whose batch size had changed, and filling and packaging had never been covered. You then learn that section 211.100 requires changes to be drafted, reviewed and approved, and that every change needs a description, a rationale, an implementation plan and quality unit approval before it is made. The module shows changes that cannot affect the tablet, such as a new carton font, and a generic tablet maker in Frankfurt with a change that looked small, closed with a comparison attached. It covers a new supplier needing identity testing and evidence the material behaves the same, then maintaining qualification through monitoring, maintenance, calibration, periodic review and requalification. It ends with a recap.
What you will be able to do
- Assess the impact of a change on a validated process in writing
- Qualify a new material supplier for use in a validated process
- Keep equipment qualified through monitoring and periodic review
Why it matters
Approving before you change and checking after keeps old validation data true for the process you run today.
Practice: Practice: Change, maintenance, requalification · 3 questions
- Practice exercise: Change assessment for a second metformin supplierabout 12 min
Part 3Part C: Putting it together at JKL PharmaApprox. 13 min
- Putting it together at JKL Pharma13 min
Puts FDA process validation together at JKL Pharma, from design to continued verification, with a road map, checklist and the final exam.
What this module covers
Starts with a test: if an FDA investigator walked onto JKL's new line tomorrow, could the team show one connected story from design to today? You then follow JKL's metformin line step by step, each drawn from a course module: scale-up studies showing impeller power, not time, controls granulation; the control strategy in the master record; qualified press, dryer, coater and water; PPQ with the dryer deviation discussed in full and approved before release; trending; and change control. You see JKL's answers written into its validation procedure and the Module 1 cases revisited. The module gives a road map, map, gap, fix, trend and extend, one product at a time, with ten questions as a checklist. It ends with the scenario-based final exam and its 60% mark.
What you will be able to do
- Trace one product's validation from design to continued verification
- Use the road map and checklist to review your own site
- Explain the evidence an investigator expects to see connected
Why it matters
Telling one connected story with evidence is what lets your team answer an investigator on the line tomorrow.
Practice: Practice: Putting it together at JKL Pharma · 3 questions
Frequently asked questions
Your questions,
answered.
About Process Validation and Equipment Qualification (US FDA), its certificate and enrolment.
Ask SterlingIs Sterling Academy a good choice for US FDA cGMP training?
Yes. Sterling Academy's US FDA cGMP courses are built by the Sterling consulting group, which has taken organisations to certification across 8,100+ client engagements in 60+ countries over 20+ years. They cover the awareness, implementation and specialist levels, always on the current edition, with practice questions that show the right answer. Each course ends with a final exam and a verifiable certificate that anyone can check online, plus a LinkedIn badge, and client administrators can show an auditor exactly who has been trained. You will be able to apply Process Validation and Equipment Qualification (US FDA) at work and show your competence with confidence. Sterling Academy courses carry the same content as Sterling's classroom training, whose certificates are trusted and accepted by all major certification bodies, as evidence of training at client audits for over 20 years.
Awareness: US FDA GMP Awareness for Pharmaceuticals (21 CFR Parts 210 and 211) · Implementation: US FDA Current Good Manufacturing Practice (cGMP) Implementation for Pharmaceuticals (21 CFR Parts 210 and 211) · Specialist: Aseptic Processing Training (US FDA)
What is FDA process validation training?
It is training on how to validate drug manufacturing processes to US FDA requirements. This course covers 21 CFR Part 211 and FDA's 2011 guidance: the three-stage life cycle, process design, equipment and utility qualification, PPQ protocols and reports, continued process verification and change control, using a built tablet line in Mumbai.
Who needs process validation training?
Anyone who designs, qualifies or approves manufacturing processes needs it: validation, QA and QC staff, production and engineering managers, technical services and technology transfer teams, and consultants working on drug products for the US market. Quality unit staff who approve protocols and reports benefit most.
What are the three stages of process validation?
FDA's 2011 guidance defines three stages. Stage 1 is process design, building knowledge and a control strategy. Stage 2 is process qualification, covering facility, utility and equipment qualification and process performance qualification. Stage 3 is continued process verification, which confirms during routine production that the process stays in control.
How many PPQ batches does FDA require?
FDA does not set a fixed minimum number of PPQ batches. Its questions and answers on production and process controls say the number should be justified by the manufacturer based on process knowledge and risk. Module 8 shows how to justify the number in the protocol.
What is the difference between equipment qualification and process validation?
Equipment qualification shows that facilities, utilities and equipment are suitable and work as intended; process validation shows that the whole process consistently makes product that meets its quality attributes. Qualification is part of Stage 2 in FDA's life cycle, and both are needed before commercial distribution.
How long does the course take?
The course has about 3 hours of video across 12 modules, plus four practice exercises of 12 to 15 minutes each. It is on demand, so you can work through it alongside a live validation project and replay any module.
Do I get a certificate?
Yes, you receive a Sterling Academy Certificate of Competence. The course ends with a scenario-based multiple-choice exam drawn from the question bank; a score of 60% or more meets the criteria, and one retake is included if your first attempt falls short.
How much does FDA process validation training cost?
The course costs US$99 per learner, including all 12 video modules, practice questions, four practice exercises with model answers, the final exam and the certificate. For validation teams, contact us for a quote for your organisation; company plans include a client administrator, progress reports and one invoice.
Does the course cover IQ, OQ and PQ?
Yes. FDA's guidance describes qualification activities without the labels IQ, OQ and PQ, which are industry terms. Modules 5 and 6 explain FDA's activities, map them to the familiar terms, and show how to verify the build, calibration and operation under load of a new tablet press.
Is this course for EU sites too?
It is written for products made for the US market and follows US FDA rules and guidance. Sites supplying the EU follow EU GMP Annex 15, which Sterling Academy covers in its separate Qualification and Validation Training (EU GMP Annex 15) course.
Can my validation team take the course together?
Yes, through a Sterling Academy company plan. A client administrator adds your validation, QA and engineering staff, assigns the course, and follows progress reports showing who holds a certificate, and your organisation receives one invoice. Contact us for a quote for your organisation.
Your certificate
Prove what you learned.
Share it with confidence.
You will be able to apply Process Validation and Equipment Qualification (US FDA) at work and show your competence with confidence. Your certificate can be verified online in seconds, so certification body auditors, employers and clients can confirm your training instantly.
Complete the course and its final exam and you receive a Sterling Academy Certificate of Completion, verifiable online by QR code, with a LinkedIn badge to share.
- Pass mark
- 70%
- Prerequisites
- None
Sterling Academy courses carry the same content as Sterling's classroom training, whose certificates are trusted and accepted by all major certification bodies, as evidence of training at client audits for over 20 years.
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