Manufacturing Process Validation · Self-paced

Process Validations that identify the validated state, then maintain it.

Decide what to validate, set risk-based sample sizes, apply DoE, capability studies and Gage R&R, and run IQ, OQ and PQ that align with FDA and ISO 13485, practiced step-by-step on a CNC mill example.

Enroll for $1,500Try Chapter 1 free

Training a team or paying by purchase order? Email us

5 chapters · about 16–20 hours · IQ, OQ, PQ, DoE, Gage R&R

Top Medical Device Consulting 2026 award badge from MedTech Business ReviewTop Medical Device Consulting 2026 MEDTECH Business ReviewWorked example: CNC mill IQ, OQ and PQ plus a complete set of PV templates
One OQ protocol line, CNC-milled componentIllustrative example
Typical entry
Parameter
Spindle speed
Setting
Nominal
Samples
3 runs
Evidence
Sample size ?No link to risk
After this course
Parameter
Spindle speed, challenged at both ends of the operating window
CQA
Critical bore diameter, measured with a qualified gage
Samples
Set by the risk of the CQA, with stated confidence and reliability
Evidence
Risk-based sample sizeGage R&R passedCapability shown
Chapter 5 works through IQ, OQ and PQ on a CNC mill.
Sound familiar?

The validation exists. It just doesn't prove the process.

  • Validations are done because the auditor expects them, not to understand the process.
  • Sample sizes are "3 lots" or "30 parts," with no link to risk.
  • The measurement system was never qualified, so nobody can trust the data.
  • Once the PQ is signed, nobody checks whether the process stays in a validated state.

That isn't a lack of effort. It's the lack of a method that connects risk, statistics and qualification. This course teaches that method.

Check your process validation

How does your process validation hold up?

Answer for the most recent process your team validated. Your answers stay on this page and aren't sent anywhere.

  1. Does your Validation Master Plan say which processes are validated and which are verified, and why?
  2. Are your Critical Quality Attributes linked to Risk Management?
  3. Is each sample size set by risk, with stated confidence and reliability?
  4. Was the measurement system qualified with Gage R&R or MSA before the data was collected?
  5. After the PQ, do control plans and charts show the process stays in a validated state?
Course reviewer, on the DQS Process FMEA course
"Great material. Best I've ever seen in the industry."
Mike Z.Senior Management Consultant
What changes

After the course, your team will be able to

Regulations · VMP · validate or verify

Decide what to validate, and why

Apply FDA, ISO and GHTF expectations, choose between validation and verification, and build a Validation Master Plan that covers retrospective validation and re-validation.

Risk · CQAs · sample size

Plan validations from risk

Link Critical Quality Attributes to Risk Management, set defensible sample sizes with a rubric, and write protocols and reports that hold up.

DoE · ANOVA · capability · Gage R&R

Use the right statistical tools

Apply Design of Experiments, ANOVA, capability studies, Gage R&R and Measurement Systems Analysis where they matter in PV.

IQ · OQ · PQ · control plans

Qualify the process and keep it validated

Run IQ, OQ and PQ with a worst-case, product family approach, then maintain the validated state with control plans and charts.

Is this right for you?

Built for the people who validate, run and defend manufacturing processes

See who it's for, and who it isn't

This course is for you if

  • You are a manufacturing, process or quality engineer who writes or executes validations.
  • You are moving a device from development into production.
  • You own the Validation Master Plan or approve protocols and reports.
  • You are responding to audit findings on process validation.
  • You work at a contract manufacturer or supplier making medical device components.

It is probably not for you if

  • You want a one-hour overview of IQ, OQ and PQ vocabulary.
  • You want to fill in templates without learning the reasoning behind them.
How the course is built

Four stages, from regulations to a qualified process

Explanatory videos, handouts, a CNC mill worked example and a complete set of PV templates, with quizzes to confirm you have it before moving on.

Stage 1

Regulations and expectations

What regulators expect from process validation, key terminology, and US, ISO and GHTF requirements.

Chapter 1
Stage 2

Validation elements

Process inputs, validation vs. verification, IQ, OQ and PQ basics, retrospective validation, re-validation and the Validation Master Plan.

Chapter 2
Stage 3

Validation design

Planning, Risk Management and Critical Quality Attributes, sample size, protocol development and reports.

Chapter 3
Stage 4

Tools and qualification

DoE, ANOVA, capability, Gage R&R, MSA, worst case and control plans, then IQ, OQ and PQ on a CNC mill.

Chapters 4–5
  • 16–20 hrs of learning in 180 lessons
  • Quizzes throughout, plus a final exam
  • PV templates for IQ, OQ and PQ
  • Live discussion with a DQS expert

Not sure yet? Start Chapter 1 free. You get access inside the course as a student, including the Chapter 1 quizzes, before you decide.

Chapters marked "Your gap" match the answers you gave in the validation check.

  1. Introduction to Process ValidationYour gap
  2. Process Validation ElementsYour gap
  3. Process Validation DesignYour gap
  4. Process Validation ToolsYour gap
  5. Installation, Operational, and Performance QualificationYour gap
For managers and team leads

Validation is a team effort. Train the team on one method.

When manufacturing, engineering and quality share the same method, sample sizes are defensible, protocols read the same across lines, and audits go faster.

  • A shared vocabularyOne way to plan, execute and report IQ, OQ and PQ across every line and site.
  • Pairs with the rest of the libraryProcess FMEA, Design Validation and Safety Risk Management courses build on the same foundation.
  • Impact your business positivelyInvestment in professional development is not a 'nice-to-have'. It has real, tangible benefits.Get the white paper
Dr. John Salvato, founder of Design Quality Services
Your instructor

Dr. John Salvato

Founder and President, Design Quality Services

John has spent more than 30 years in medical device and automotive quality and regulatory work. Since founding DQS in 2017 he has helped device makers move products from development into validated production, and defended that work with agencies and regulatory bodies.

ISO 13485 Lead AuditorISO 14971FDA Design ControlsIEC 62304

"What we offer is capability-focused training. We understand the regulation, but we are also going to teach you how to implement it smartly."

Before you enroll

Questions people ask

Can I try it before I buy?
Yes. Start Chapter 1 free. You get access inside the course as a student and work through the full chapter on process validation expectations and regulations, including its quizzes, before you decide.
How much time does it take?
Plan on about 16 to 20 hours. The course is self-paced across 5 chapters and 180 lessons, with about 1.5 hours of video and the rest in reading, handouts, examples and quizzes. You have 60 days of access, plus a live discussion with a DQS expert to make sure the concepts are clear.
Do I need a statistics background?
No. Chapter 4 is a practitioner's introduction to DoE, ANOVA, capability studies, Gage R&R and MSA, focused on how each tool is used in process validation.
How do I set a defensible sample size?
Chapter 3 connects sample size to Risk Management and gives you a rubric for choosing it, so you can explain the number to an auditor instead of defaulting to "3 lots."
Do I get templates?
Yes. The course includes a complete set of PV templates, with example IQ, OQ and PQ templates and a debrief of each on a CNC mill.

Validate to prove the process, not just to pass the audit.

Learn a process validation method your team can defend in every audit and use on every line.

$1,500 · self-paced · start today

Enroll nowTry Chapter 1 free

Training a team or paying by purchase order? Email us