Webinar Pack
Pack of TEN: Best Selling Medical Devices Webinars by GlobalCompliancePanel Actual Price:
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Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF).
DHF, DMR, DHR, Technical File and Design Dossier Key Requirements and Future Directions This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR.
Interfacing Design Verification, Process Validation and Design Validation
Instructors: Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. ..more John E Lincoln Consultant, Medical device and Regulatory affairs
There is confusion between the requirements for Design Verification, Process Validation and Design Validation.
Device Changes and the 510(k) The majority of medical devices are cleared for marketing in the U.S.
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures. ..more
by the FDA under the 510(k) process.
FDA's New Enforcement of 21 CFR Part 11 FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations.
The 510(k) Submission: Requirements, Contents, and Options This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly.
The New FDA-Product Approval, Inspection, and Enforcement The US Food and Drug Administration has recently released information about its new strategies as a result of the new administration.
Product Risk Management - ISO 14971:2007 This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.
Design History Files: Their Content and Control After attending this presentation the attendee should come away with a good knowledge of what the requirements for Design History Files are from both a domestic and international perspective, how to minimize DHF content so that the requirements are still.
Complaint Handling in Compliance with FDA and ISO Regulations
Edwin L Bills Principal Consultant, Bilanx Consulting LLC During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. ..more Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. ..more Albert Cefalo Regulatory Affairs Specialist, Analogic Corporation Albert Cefalo, Regulatory Affairs Specialist, Analogic Corporation. Chuck has a BS degree from Franklin Pierce College and a Graduate certificate in RA from Northeastern University...more
Your Necessity is our Priority
This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications.
Click here to buy the webinar pack It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe