This webinar will show how you can perform meaningful, results driven 510(k) / change analysis activities and reporting so as to satisfy FDA requirements.
Why Should You Attend:
Control of medical device changes and a current 510(k) are big issues in recent FDA studies. The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities, and may soon mandate more rigorous reporting.
Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Growing high-profile field problems indicate that change control and its effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis . A growing push by the Agency to strengthen the 510(k) process in the U.S. is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised.
For most companies, the fixes are not rocket-science, but require the implementation of formal methods with documented, and defensible rationale; which will also prepare industry for further 510(k) changes in the future. This training will help you achieve this.
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.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities. It will discuss how companies can best document their decision when a new 510(k) filing is warranted.
It will assist in the implementation of formal methods with documented, and defensible rationale; which will also prepare industry for further 510(k) changes in the future. This applies to companies in the Medical Device and combination products fields.
The employees who will benefit include:
- Senior management
- Regulatory affairs
- Quality Assurance
- Production
- R&D and Engineering
- All personnel tasked with product hazard reduction and problem solving
Instructor Profile:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 29 years experience in U.S. FDA-regulated industries, 15 of which as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment incl+D33uding QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.
He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on virtually all CGMP issues. John is a graduate of UCLA.
