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

VIEWS: 27 PAGES: 1

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.

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 Main   Device Changes and the 510(k)
                                                                                                                                           Call: 800-447-9407
 Device Changes and the 510(k)                                                                                                             Fax: 302-288-6884

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                                                                                                  |                    |
                    Instructor : John E Lincoln
                    Product Id : 600318                                                                                                     Webinar Packs

                                                                            Training Options                Duration: 60 Minutes  
                                                                                                                                            Top Selling Medical Devices
                                                                               Wednesday, November 3, 2010                                  Webinars - Pack of Three
                                                                                                                                            Courses
                                                                               10:00 AM PDT | 01:00 PM EDT
                                                                                                                                            Price: $695.00
Overview: The majority of medical devices are cleared for
                                                                            b
                                                                            c
                                                                            d
                                                                            e
                                                                            f
                                                                            g Live live online training only for one participant
marketing in the U.S. by the FDA under the 510(k) process.
                                                                               Price: $245.00                                               Top Selling Webinars by Dr.
                                                                                                                                            Ludwig Huber - Pack of Three
The FDA holds companies responsible for filing new 510(k)s                  e
                                                                            c
                                                                            f
                                                                            g Corporate Live 4 to 10 participants from a single
                                                                            d                                                               Courses
when one change is major enough to impact safety /                             location (For multiple locations contact Customer Care)
effectiveness, or when a series of lesser changes finally reach                Price: $995.00
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
                                                                            e
                                                                            g Recorded Access recorded version only for one
                                                                            d
                                                                            c
                                                                            f                                                               News
changes. What approaches are required for product changes;                     participant; unlimited viewing for 6 months ( Access
for process changes. How is the process risk-based? How to                     information will be emailed 24 hours after the
maximize the process against scarce resources. What are the                                                                                 Recalls and Safety Alerts: Warning on
                                                                               completion of live webinar)
                                                                                                                                            Proton Pump Inhibitors and Fracture
different considerations for CE-marked product?
                                                                               Price: $295.00                                               Risk

Areas Covered in the Session:                                                                                                               Recalls and Safety Alerts: Lifeline and
   U.S. FDA device clearance / approval                                                                                    Refund Policy    ReviveR AED Battery Packs Recalled
   FDA's and EU's emphasis                                                                                                                  Recalls and Safety Alerts: Update on
   Product changes and filing a new 510(k) – who's responsible                                                                              Counterfeit Polypropylene Mesh
   Tracking and evaluating changes – the "tipping point"
                                                                                                                                            Recalls and Safety Alerts: Thrombosis
   Is the process "risk based"?                                                                                                             with Off-Label Promacta Use
   K-97-1 and the FDA's "Decision Tree"
                                                                                                                                            Recalls and Safety Alerts: Severe
   Documenting the process / rationale                                                                                                      Liver Injury with Orlistat (Xenical,
   Resolving a "wrong decision"                                                                                                             Alli)

Who Will Benefit:
   Senior management, project leaders, internal / external consultants
   Regulatory affairs
   Quality systems personnel / QAE
   R&D and engineering staff                                                                                                                         Subscribe Newsletter
   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.


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