GMP for Medical Devices and FDA 21 CFR PART 820

FDA 21 CFR 820 training

Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through ourย certificate online checker. They can also be shared on Linkedin.


All common medical procedures require medical devices and they are used by laypersons at home and by healthcare professionals in medical facilities. From palliative care to diagnosis, prevention, and screening, medical devices can do it all. It is therefore vital that they comply with the highest standards of quality.

GMP or Good Manufacturing Practice for medical devices refers to a set of guidelines and regulations which ensure that medical devices are consistently produced with high quality standards. Compliance with GMP for medical devices is important as it ensures the quality, safety, strength, and purity of the final product.

This online training also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services






Lesson 1: Design Controls of Medical Devices

  • What does design control refer to ?
  • What is the process for applying design controls to medical devices ?


Lesson 2: Document Controls of Medical Devices

  • Document approval and distribution


Lesson 3: Purchasing Controls of Medical Devices

  • Evaluation of Suppliers, Contractors, and Consultants
  • Extent of control
  • Purchasing Data


Lesson 4: Identification and Traceability


Lesson 5: Production and Process Controls


Lesson 6: Acceptance Activities


Lesson 7: Requirements for Nonconforming Product


Lesson 8: Corrective and Preventive Action


Lesson 9: Labeling and Packaging Controls of Medical Devices


Lesson 10: Handling, Storage, Distribution, and Installation of Medical Devices


Lesson 11: Records

  • Device History Record (DHR)
  • Device Master Record (DMR)
  • Device History Record (DHR)


Lesson 12: Servicing and Statistical Techniques






Dr. Ciaran McEnister
Senior Pharmaceutical Executive with 25+ years of experience in Medical Device Development, Translational Research, Pharmaceutical development, Pharmacologic/Toxicologic and Preclinical research and Regulatory compliance of small and large molecule drug candidates. Dr. McEnister has an extended experience as senior quality manager at Merckx, BioDevices and IPSEN.


USD: United States (US) dollar ($) ^


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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00 / year

$60.00 / year

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