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Site language : English - Français
Ref : 28700
Event :Device Changes, FDA Changes, and the 510(k)-2019

Date :Wednesday March 20th, 2019

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

Overview:
Learn what approaches are required for product changes, for process changes, and Tracking and evaluating changes - the "tipping point" , and how is the process risk-based?
 
Areas Covered in the Session:
Is the process "risk based"?
K-97-1 and the FDA's "Decision Tree"
Documenting the process / rationale
Resolving a "wrong decision"
 
Who Will Benefit:
Senior Management, Project Leaders, Internal / External Consultants
Regulatory Affairs
Quality Systems Personnel / QAE
R&D and Engineering Staff
 
Speaker Profile:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
 
Event Fee: One Dial-in One Attendee Price: US$150.00
 
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: compliance4all14@gmail.com
https://www.compliance4all.com/control/w_product/~product_id=502271LIVE?channel=doctorama_Mar_2019_SEO

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Details

Device Changes, FDA Changes, and the 510(k)-2019 Pharmacy - Medicine - Bio-Technologies - Public Health
education training, compliance training online, training in san diego
Everyone, New product development, Regulatory Submissions, Driving company-wide quality initiatives, Under a risk-justified approach
50 1 --
English

Other

For more information on Device Changes, FDA Changes, and the 510(k)-2019, plsase contactr Compliance4All

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