Seminars and Lectures on 21 CFR Parts 820 and 11

#1
Dear coves

I work for a class III Medical Device Manufacturer as a Quality Engineer. Can you all please advise what kind of seminars, learning materials, tutorials can be attended to keep my self educated of the knowledge and updates currently in the industry.

- QE.
 
Elsmar Forum Sponsor

Michael Malis

Quite Involved in Discussions
#4
You can:

1. Attand FDA and industry meetings – next one is scheduled for mid –January.

2. Check with Advamed and Small Manufacturers Association.
 
B

Bunny

#6
FDA's website has a learning portal called CDRH Learn. On it you'll find webinars and power point presentations covering FDA basics, including Part 820.
 
Likes: QE
Y

yana prus

#9
Medical Device Quality Systems Manual - A Small Entity Compliance Guide will be an excellent start and will provide you with in-depth (and hands-on) understanding of QSR (21 CFR 820) requirements and implementation.
http :// www .fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/default.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Device Advice in CDRH is terrific resource as well:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

for PMA submissions the following link can be helpful:
Premarket Approval (PMA)
 
Last edited by a moderator:

bio_subbu

Super Moderator
#10
Dear coves

I work for a class III Medical Device Manufacturer as a Quality Engineer. Can you all please advise what kind of seminars, learning materials, tutorials can be attended to keep my self educated of the knowledge and updates currently in the industry.

- QE.
Hi QE

I would suggest you to refer ASQ CBA (Certified Biomedical Auditor) body of knowledge. You can find references with respect to medical devices industry to collect for a learning material. You can find references not only for FDA QSR regulation also European medical devices regulation, auditing fundamentals, auditing and inspection process, biomedical quality system regulation, technical biomedical knowledge such as risk management, biocompatibility sterility and so on.

Also I request you to refer the existing post#9 Should I invest in ISO standards for the CBA (Certified Biomedical Auditor) exam?

Refer existing thread on USFDA's prerecorded online training modules in CDRH Learn

Presentation, Articles and Webinars:

Refer Pathwise Free downloads, you can find presentation on following topics

FDA QSIT, CAPA, Management Review, Design control, and cGMP for combination products.

Pre Recorded Webinars are available on the following topics:

CAPA for Life Sciences, overview Quality System Regulation (QSR), Problem Solving in the Lean Supply Chain, Risk Management Panel, Six Steps to Better Device Labeling, The Application of Lean Management Systems to Life Sciences.

Article available for following topics:

GHTF Proposed CAPA Guidance for Medical Device Manufacturers, The Commonalities Between Risk, Verification & Validation, Challenges of International Medical Device Labeling, How to Kick Start your CAPA process, Fitting Human Factors in the Product Development Process, Standard Work for Problem Solving

Other Management Articles

The 5 "W"s of Quality Agreements, Designing a Winning CAPA System, The Secrets of Team Facilitation, What's Wrong? Why Do We Have Repeat Investigations?, Risk Management and Assessment of IVD Kits, Qualification and Validation of Middleware and Service-Oriented Architectures

For download the above materials you need to register once.

Regards
S. Subramaniam
 
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