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About

This training covers FDA 21 CFR Part 820 requirements, focusing on key records such as DMR, DHR, and QSR. It includes documentation control, traceability, complaint handling, CAPA linkage, and distribution requirements. It also highlights labeling, service reports, MDR considerations, and FDA inspection expectations.

The content explains documentation and record control under FDA QSR, including DMR, DHR, complaint handling, and traceability. It covers CAPA integration, service and returned product handling, and basic statistical techniques. FDA inspection processes and compliance requirements are also outlined.

Course Syllabus

  1. What does design control refer to?
  2. Design is where most recalls are born
  3. Applicability under § 820.30(a)
  4. Ten elements of § 820.30
  5. Design & development planning
  6. Design input — the requirements
  7. Design output — the specifications
  8. Design review — formal gates
  9. Verification vs. Validation
  10. Design transfer and changes
  11. Design History File (DHF)

  1. A QMS is only as good as its documents
  2. What Part 820 requires
  3. Which documents must be controlled?
  4. Approval and issue
  5. Getting the right doc to the right place
  6. Document change control
  7. Revision, effective date, obsolescence
  8. Document control cited on Form 483
  9. Electronic document control + Part 11
  10. Doc control you can audit yourself

  1. Your supplier's mistake is your device's defect
  2. Three elements of Purchasing Controls
  3. Evaluating suppliers, contractors & consultants
  4. The Approved Suppliers List (ASL)
  5. Extent of control — risk-proportional
  6. Purchasing data — what's on the PO
  7. Quality agreements that prevent surprises
  8. Monitoring suppliers after approval
  9. Inadequate purchasing controls
  10. Purchasing-control self-audit

  1. Identification vs. Traceability
  2. Identification at every stage
  3. The purpose: prevent mix-ups
  4. Which devices require traceability?
  5. Data captured per traced device
  6. Unique Device Identification (21 CFR 830)
  7. Acceptance status labels in action
  8. Cannot trace the batch
  9. The mock-recall exercise
  10. ID & traceability self-audit

  1. Production is where design meets reality
  2. Process validation — when and how
  3. Processes typically requiring validation
  4. Environmental controls
  5. Personnel and contamination control
  6. Equipment and manufacturing materials
  7. Automated processes — validate the software
  8. Production records — what to capture
  9. Failure to validate
  10. Process changes — controlled, not casual

  1. Three points where acceptance happens
  2. Receiving acceptance
  3. In-process acceptance
  4. Finished device acceptance
  5. Acceptance records — what to capture
  6. Acceptance status must be visible
  7. Skip-lot and reduced inspection
  8. Released before acceptance
  9. Sampling rationale — required by § 820.80
  10. Acceptance-activity self-audit

  1. What is nonconforming product?
  2. Four things the rule requires
  3. What the NC record captures
  4. Evaluation — who decides what to do
  5. Four disposition options
  6. Rework — not a free pass
  7. Physical and system segregation
  8. Concessions — accept with justification
  9. Use-as-is as policy
  10. NC-product self-audit

  1. Corrective vs. Preventive Action
  2. Data sources that feed CAPA
  3. The CAPA process
  4. Investigation and root cause
  5. Effectiveness — proving the fix works
  6. Communication to management review
  7. CAPA records — document everything
  8. CAPA — the #1 FDA 483 category
  9. NC vs. CAPA — don't conflate them
  10. CAPA self-audit

  1. A labeling error is a recall in waiting
  2. Labeling — six concrete controls
  3. Packaging — what it must achieve
  4. What the label must contain
  5. Label inspection — the mix-up gate
  6. Control number — the traceability key
  7. Labelling = most common recall cause
  8. Prove the pack protects the device
  9. Label and packaging changes
  10. Labeling & packaging self-audit

  1. Four clauses, one continuous journey
  2. Handling — prevent mix-up and damage
  3. Storage — controlled areas, correct conditions
  4. Distribution — release only what's ready
  5. Installation — part of the device
  6. Cold chain, ESD, fragile — transport considerations
  7. Typical storage requirements
  8. Cannot identify first consignee
  9. Reverse logistics — the return journey
  10. Handling / Storage / Distribution / Installation self-audit

  1. DMR · DHR · QSR — what each captures
  2. Device Master Record — the recipe
  3. Device History Record — the build evidence
  4. Quality System Record — the QMS documentation
  5. General record requirements
  6. Complaint files — records of another kind
  7. Electronic records + Part 11
  8. Records not retrievable
  9. DMR · DHR · QSR — at a glance
  10. Records self-audit

  1. Servicing — a regulated activity
  2. Service report → complaint file
  3. Mandatory content per record
  4. Statistical techniques — the quiet giant
  5. Valid sampling plans and rationale
  6. Process capability — speaking quantitatively
  7. Monitoring in real time
  8. Sampling plan has no basis
  9. Service + statistical data → trending
  10. Servicing + statistics self-audit

Course Benefits

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Fully compliant

This course follows the guidance of Annex 13 of the European Commission's GMP guidelines

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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.

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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.

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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.

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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.


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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