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GMP for Medical Devices CFR 820 Course & Certification
Intermediate
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GMP for Medical Devices CFR 820
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About
The GMP for Medical Devices – 21 CFR 820 Course & Certification is designed to provide a practical understanding of the U.S. FDA Quality System Regulation (QSR) for medical device manufacturing. The course focuses on ensuring product quality, safety, and regulatory compliance throughout the device lifecycle.
This course covers 21 CFR Part 820 requirements, including design controls, document control, production and process controls, corrective and preventive action (CAPA), complaint handling, supplier management, and device traceability. It also emphasizes quality system implementation, audit readiness, and FDA inspection expectations. Upon successful completion, learners receive a certification demonstrating competency in GMP for medical devices under 21 CFR 820.
Who Should Enrol?
- Medical Device Manufacturing Professionals
- Quality Assurance and Quality Control Teams
- Regulatory Affairs Professionals
- Validation and Engineering Teams
- Production and Operations Staff
- Medical Device Industry Employees
- Life Science, Pharmacy, Engineering, and Healthcare Graduates
What you will learn
Understand the fundamentals of GMP for medical devices under 21 CFR 820, including regulatory expectations and quality system requirements.
Learn key quality system elements such as design controls, document control, purchasing controls, and production and process controls.
Gain knowledge of essential operational practices including traceability, acceptance activities, nonconforming product management, CAPA, labeling, and distribution controls.
Develop an understanding of device quality records (DMR, DHR, QSR), servicing requirements, statistical techniques, and overall compliance to ensure product safety and regulatory readiness.
Course Syllabus
- What does design control refer to?
- Design is where most recalls are born
- Applicability under § 820.30(a)
- Ten elements of § 820.30
- Design & development planning
- Design input — the requirements
- Design output — the specifications
- Design review — formal gates
- Verification vs. Validation
- Design transfer and changes
- Design History File (DHF)
- A QMS is only as good as its documents
- What Part 820 requires
- Which documents must be controlled?
- Approval and issue
- Getting the right doc to the right place
- Document change control
- Revision, effective date, obsolescence
- Document control cited on Form 483
- Electronic document control + Part 11
- Doc control you can audit yourself
- Your supplier's mistake is your device's defect
- Three elements of Purchasing Controls
- Evaluating suppliers, contractors & consultants
- The Approved Suppliers List (ASL)
- Extent of control — risk-proportional
- Purchasing data — what's on the PO
- Quality agreements that prevent surprises
- Monitoring suppliers after approval
- Inadequate purchasing controls
- Purchasing-control self-audit
- Identification vs. Traceability
- Identification at every stage
- The purpose: prevent mix-ups
- Which devices require traceability?
- Data captured per traced device
- Unique Device Identification (21 CFR 830)
- Acceptance status labels in action
- Cannot trace the batch
- The mock-recall exercise
- ID & traceability self-audit
- Production is where design meets reality
- Process validation — when and how
- Processes typically requiring validation
- Environmental controls
- Personnel and contamination control
- Equipment and manufacturing materials
- Automated processes — validate the software
- Production records — what to capture
- Failure to validate
- Process changes — controlled, not casual
- Three points where acceptance happens
- Receiving acceptance
- In-process acceptance
- Finished device acceptance
- Acceptance records — what to capture
- Acceptance status must be visible
- Skip-lot and reduced inspection
- Released before acceptance
- Sampling rationale — required by § 820.80
- Acceptance-activity self-audit
- What is nonconforming product?
- Four things the rule requires
- What the NC record captures
- Evaluation — who decides what to do
- Four disposition options
- Rework — not a free pass
- Physical and system segregation
- Concessions — accept with justification
- Use-as-is as policy
- NC-product self-audit
- Corrective vs. Preventive Action
- Data sources that feed CAPA
- The CAPA process
- Investigation and root cause
- Effectiveness — proving the fix works
- Communication to management review
- CAPA records — document everything
- CAPA — the #1 FDA 483 category
- NC vs. CAPA — don't conflate them
- CAPA self-audit
- A labeling error is a recall in waiting
- Labeling — six concrete controls
- Packaging — what it must achieve
- What the label must contain
- Label inspection — the mix-up gate
- Control number — the traceability key
- Labelling = most common recall cause
- Prove the pack protects the device
- Label and packaging changes
- Labeling & packaging self-audit
- Four clauses, one continuous journey
- Handling — prevent mix-up and damage
- Storage — controlled areas, correct conditions
- Distribution — release only what's ready
- Installation — part of the device
- Cold chain, ESD, fragile — transport considerations
- Typical storage requirements
- Cannot identify first consignee
- Reverse logistics — the return journey
- Handling / Storage / Distribution / Installation self-audit
- DMR · DHR · QSR — what each captures
- Device Master Record — the recipe
- Device History Record — the build evidence
- Quality System Record — the QMS documentation
- General record requirements
- Complaint files — records of another kind
- Electronic records + Part 11
- Records not retrievable
- DMR · DHR · QSR — at a glance
- Records self-audit
- Servicing — a regulated activity
- Service report → complaint file
- Mandatory content per record
- Statistical techniques — the quiet giant
- Valid sampling plans and rationale
- Process capability — speaking quantitatively
- Monitoring in real time
- Sampling plan has no basis
- Service + statistical data → trending
- Servicing + statistics self-audit
- 📘 Bonus: GMP for Medical Devices – 21 CFR 820 eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
Fully compliant
This course follows the guidance of Annex 13 of the European Commission's GMP guidelines
Certified
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
Affordable
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Time-saving
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.
Reliable and trustworthy
This course was written by McCarthy Consultant Services Inc (Canadian specialists in regulatory work to support the global pharmaceutical, biotechnology, medical device, food, natural health products and cosmetic industries). You will also stay up to date with any legislative changes in GMP relating to IMPs as our training courses are constantly monitored, reviewed and updated.
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