The FDAs New Draft Guidance on Medical Device Change(s) and the 510(k) (Medical DeviceTraini)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Oct 04, 2011 End Date/Time: Oct 04, 2011
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This webinar will provide valuable guidance to regulated companies in development and implementation of Product Risk Management Planning. It will expand this tool into training, marketing, validation, root cause analysis, CAPA / failure investigations, GMP auditing, and liability reduction. Regular use of these few simple but powerful tools in a Product Risk Management File and Report template can contribute greatly to reduction of product liability, company-wide cost reduction efforts, less chance of recalls, and an improved bottom line.

Areas Covered in the Seminar:

- Key requirements of the new Draft Guidance on Changes and the 510(k).
- Fully capture your device change control process.
- Expected sources of information for evaluation and inclusion.
- Two approaches to the use of FDA's K97-1 Memo.
- Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes.
- Change reporting "tipping point" -- with one change or cumulative.
- Which of the three major 510(k) formats should be used.
- How to complete, document and control as a 'living' document


Online Event
2600 E. Bayshore Road
Palo Alto
United States