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