Live event The 510(k): Its Purpose, Compilation, and Submission

Website https://compliance2go.com/product/?pid=CP2014-396 | Edit Freely

Category Biotechnology ;Medical Device ;Pharmaceutical

Deadline: February 05, 2015 | Date: February 06, 2015

Venue/Country: Online, U.S.A

Updated: 2015-01-23 17:36:29 (GMT+9)

Call For Papers - CFP

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". 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:

FDA device clearance / approval

FDA's and EUâ?™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"?

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.

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Certificate of Attendance