ONLINE TRAINING 2016 - Device Changes and the 510(k) - By AtoZ Compliance
View: 330
Website http://bit.ly/1XfFAj1 |
Edit Freely
Category 510(k) training, fda 510 k, 510 k clearance, fda medical device approval , 510(k) submissions
Deadline: March 15, 2016 | Date: March 15, 2016
Venue/Country: New Hyde Park, U.S.A
Updated: 2016-02-10 13:56:37 (GMT+9)
Call For Papers - CFP
Key Take AwayUnderstand the approaches required for Medical Device product changes; if it’s a risk-based process and how to maximize the process against scarce resources giving different considerations for CE-marked products.OverviewThe FDA holds companies responsible for filing new 510(k) training 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?Why Should You AttendThe majority of medical devices are cleared for marketing in the U.S. by the FDA 510(k) process.Areas Covered In This WebinarWhat 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?Learning ObjectivesU.S. FDA device clearance / approvalFDA's and EU's emphasisProduct changes and filing a new 510(k) clearance ? who's responsibleTracking and evaluating changes ? the "tipping point"Is the process "risk based"?K-97-1 and the FDA's medical device approvalDocumenting the process / rationaleResolving wrong 510(k) submissionsWho Will BenefitSenior Management, Project Leaders, Internal / External ConsultantsRegulatory Affairs Personnel Quality Systems Personnel R&D and Engineering StaffPersonnel involved in Lean and Six Sigma InitiativesCAPA PersonnelSpeakers ProfileJohn E. LincolnJohn E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. 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 including 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 CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.For more detail please click on this below link:http://bit.ly/1XfFAj1Email: referralsatozcompliance.comToll Free: +1- 844-414-1400Tel: +1-516-900-5509
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.