Overview: This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.
Major modules of a DHF SOP and a TF / DD SOP will be presented and discussed - the webinar will address the development of a new, or revision of an existing DHF SOP and TF / DD to ensure they meet regulatory expectations and assist those charged with compiling, updating and/or revising these mandatory documents.C15
Why should you attend: The U.S. FDA implemented Design Control requirements in 1996/97, and yet continues to find problems in the key design control document, the Design History File (DHF). Yet this drives the Device Master Record as well as providing major support for the EU MDD's Technical File / Design Dossier. What are the FDA expectations for the DHF under Design Control? What are the EU MDD / Notified Body's expectations for the complementary TF / DD? How are they similar? What are the important differences? In what ways are they moving together under Harmonization? Evaluate some of the key inputs to both, which should form the basis for SOP's explaining the development of each.
Areas Covered in the Session:
Design Control and the DHF
The 9 Key Elements in the DHF
The DHF/DMR and the MDD's TF / DD
The 13 Key Elements of the TF / DD
Differences and Similarities
High Risk Areas
Movements Toward Harmonization
Incorporating These Points Into a Design Control / DHF SOP and a TF / DD SOP
Who Will Benefit:
Senior management primarily in Devices; some value to Drugs, Biologics, Dietary Supplements