Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

Overview:It will also 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.
Why should you Attend:One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation.
Areas Covered in the Session:DHF "Typical" Contents and DeliverablesThe DMR and DHR / Lot / Batch RecordTF / DD Required ContentsParallel Approaches to Documentation - TeamsFDA and NB Audit Focus
Who Will Benefit:QARAR&DEngineeringProductionOperationsMarketing
Speaker Profile: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.
Event Fee: One Dial-in One Attendee Price: US $150.00
Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: compliance4all14@gmail.com