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 Deliverables
The DMR and DHR / Lot / Batch Record
TF / DD Required Contents
Parallel Approaches to Documentation - Teams
FDA and NB Audit Focus
Who Will Benefit:
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
Compliance4All DBA NetZealous,
Email: [email protected]