The 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. The speaker will show how the regular use of a 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 three types of 510(k)s.
- 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.
- 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.
