When: |
08 Mar through 08 Mar 2017 | |
CFP Deadline: |
08 |
|
Where: |
Online Event | United States | |
Website URL: |
http://www.compliance4all.com/control/w_product/~product_id=501161LIVE?channel=mailer&camp=Webinar&AdGroup=brownwalker_Mar_2017_SEO | |
Sponsoring organization: |
Compliance4All | |
Categories: |
Medicine & Health - Public-Health |
Keywords:
Event description:
Overview:
The FDA and other regulatory agencies have stated that software validation can only be accomplished effectively if "risk-based".How can this be done in the "real world".
Why should you Attend:
Software has become pervasive in medical devices themselves, and in the controlling, running and monitoring of medical product processes, whether they be in the pharmaceutical, medical device, biologics or dietary supplements industries. A quick review of Internet forums will show much confusion about the subject.
Areas Covered in the Session:
Verification or Validation-FDA Expectations
The Project V&V Plan
An FDA-accepted Documentation "Model"
Product and Process/Test Facilities/Equipment Software V&V
Who Will Benefit:
Senior management in Drugs,Devices,Combination Products,Biologics,Dietary Supplements
QA / RA
Software development,Programming,Documentation,Testing teams
R&D
Speaker Profile:
John E. Lincoln is a medical device and regulatory affairs consulta...
Read more
Posting date:
11 January 2017 | 146 views
Placement:
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