Page 1

Phone: 800-447-9407

RAPS Approved Webinar on

The DHF, DMR, DHR, and the Technical File-Design Dossier - USFDA and EU MDD Requirements Date: Wednesday, November 14, 2012 Course "The DHF, DMR, DHR, and the Technical FileDesign Dossier - USFDA and EU MDD Requirements" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

Time: 10:00 AM PDT | 01:00 PM EDT Duration: 90 Minutes Instructor: John E Lincoln Location: Online Price : $245.00 (for one participant)

John E Lincoln Consultant, Medical device and Regulatory affairs,

Register Now

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. ...more

Overview: This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; selfdeclaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Areas Covered in the Session: l l

l l l l l l l

The U.S. FDA's DHF The EU's MDD and the Technical File / Design Dossier Device Classification -- U.S. FDA vs. EU MDD Design Control vs. a Product 'Snapshot in Time' DHF "Typical" Contents The DMR and DHR / Lot / Batch Record TF / DD Expected Contents Parallel Approaches to Documentation -- Teams FDA and NB Audit Focus

Who Will Benefit: l

l l l l l l l

Senior Management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Marketing

Suggest a Topic More Webinars

Click here to register for this webinar

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

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

The DHF, DMR, DHR, and the Technical File-Design Dossier - Webinar By GlobalCompliancePanel  

This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR and DH...