Device Changes and the 510(k) - Webinar By GlobalCompliancePanel

Wilmington, Delaware (PressExposure) April 19, 2012 -- Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?

Areas Covered in the Session:

U.S. FDA device clearance / approval

FDA's and EU's emphasis

Product changes and filing a new 510(k) - who's responsible

Tracking and evaluating changes - the "tipping point"

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

Personnel involved in Lean and Six Sigma Initiatives

New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach

CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems.

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. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Wednesday, May 9, 2012

10:00 AM PDT | 01:00 PM EDT

Price List:

Live : $245.00

Corporate live : $995.00

Recorded : $295.00

Phone: 800-447-9407

Fax: 302-288-6884

GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.

GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management. Apart from providing excellent training to compliance professionals by compliance & consulting experts, GlobalCompliancePanel would also focus on providing:

Information to ensure compliance and enhance quality with regulations for individuals as well as the organizations

Latest updates on industry trends, industry best practices and any modifications in the regulatory affairs

One stop destination for all your queries and to share and discuss issues, ideas and best practices and

A resource on the data sheets, whitepapers, articles, books on industry standards, training kits, software tools, insights, press releases, etc on governance, regulatory, compliances and quality management across different industries.

About GlobalCompliancePanel

GlobalCompliancePanel plays a role of bringing together the regulators or experts on regulation with the community who needs to learn or be aware of those regulations. GlobalCompliancePanel is started with the goal to create an excellent interactive platform for the experts and the user community thereby making costs of training more affordable with increased convenience.

GlobalCompliancePanel strives to understand the changing customer needs and enrich their quality of life by simply providing world-class training to increase their productivity and professional growth. Global Compliance Panel enables the companies in triggering business processes through regulatory notifications and industry alerts.

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Press Release Submitted On: April 19, 2012 at 7:51 am
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