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GMP for Medical Devices and FDA 21 CFR PART 820

 4.5/5

32

Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

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 our certificate online checker. They can also be shared on Linkedin.

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:

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

Great combination of the course and material was very well updated. Good demonstration of the hypothetical questions. Very well explained and brief illustrations of the GMP regulations for medical devices and FDA.

$60

Buy now

This course includes:

One-year access

Updated content every month

Certificate of completion

GxP-Training Benefits

Experts : We work with the world's top experts in GMP, GLP, GCP, GDP, regulatory affairs, QA and pharmacovigilance.
Validated : All our courses are CPD/CEU accredited and we deliver a unique, traceable and authentic certificate to each learner.
Self-paced : access 24/7 to the course during 12 months at your own rhythm.
Smooth Experience : Each course starts with a video and ends with an exam and a valid certificate.
Up-to-date : each course is updated on an annual basis to remain valid along the Regulatory Body recommendations.
Instant Purchase : one click to buy and immediate access. Get certified today.
LinkedIn compatible : get a valid certificate at the end of each training program and publish it on LinkedIn with a Unique and Secure Link to your registered certificate.
HR management : all course programs are available either individually or as a batch to HR managers in order to pilot employees Training, follow their progress and send reminders.
Procurement optimized : instant Purchase Order, Online payment and PDF Invoice.
LMS compliant : each course is a SCORM object that you can distribute through your corporate Learning Management System.