GMP for Medical Devices and FDA 21 CFR PART 820

4.5/5
32
FDA 21 CFR 820 training

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course :ย 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

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

 

Curriculum:

 

Introduction

 

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

 

Glossary

 

Evaluation

Author:

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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.

Reviews:

4.5/5
32
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