Compliance Training 4 All: DHF, DMR, DHR, Technical File and Design Dossier

Key Requirements and Future Directions
Event Dates
2015-05-12
Organizer
Event contact title
Compliance4all
Event contact first name
Adam
Event contact last name
Fleaming
Email
support@compliance4All.com
Event contact telephone number
8004479407
Notes
Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1G7GQxD support@compliance4all.com www.compliance4all.com
Description
This interactive program will examine the existing and proposed requirements for the U.S. FDA's DHF per the CGMPs, 21 CFR 820.30 (j) - including its derivative documents, the DMR and DHR. 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. 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"; self-declaring 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. 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. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier. Currently they serve different purposes, support different goals, but the TF/DD is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TF/DD. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both. Areas Covered in the Session: The EU's MDD and the Technical File / Design Dossier Device Classification - U.S. FDA vs. EU MDD Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies 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: Senior management in Drugs, Devices, Biologics, Dietary Supplements QA RA R&D Engineering Production Operations Marketing 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. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
Future dates
Tuesday, May 12, 2015 | 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Minutes
Partner Voices
Overview: The award-winning Orange County Convention Center (OCCC) goes the extra mile to make every day extraordinary by offering customer service excellence and industry-leading partnerships. From their dedicated in-house Rigging team to their robust Exhibitor Services, The Center of Hospitality brings your imagination to life by helping you host unforgettable meetings and events. With more than 2 million square feet of exhibit space, world-class services and a dream destination, we are committed to making even the most ambitious conventions a reality. In October 2023, the Orange County Board of County Commissioners voted to approve allocating Tourist Development Tax funding for the $560 million Phase 5A completion of the OCCC. The Convention Way Grand Concourse project will include enhancements to the North-South Building, featuring an additional 60,000 square feet of meeting space, an 80,000- square-foot ballroom and new entry to the North-South Building along Convention Way. “We are thrilled to begin work on completing our North-South Building which will allow us to meet the growing needs of our clients,” said OCCC Executive Director Mark Tester. “As an economic driver for the community, this project will provide the Center with connectivity and meeting space to host more events and continue to infuse the local economy with new money and expanding business opportunities.” Amenities: The Center of Hospitality goes above and beyond by offering world-class customer service and industry-leading partnerships. From the largest convention center Wi-Fi network to custom LAN/WAN design, the Center takes pride in enhancing exhibitor and customer experience.  The OCCC is the exclusive provider of electricity (24-hour power at no additional cost), aerial rigging and lighting, water, natural gas and propane, compressed air, and cable TV services. Convenience The Center is at the epicenter of the destination, with an abundance of hotels, restaurants, and attractions within walking distance. Pedestrian bridges connect both buildings to more than 5,200 rooms and is within a 15-minute drive from the Orlando International Airport. The convenience of the location goes hand-in-hand with top notch service to help meet an event’s every need. Gold Key Members The OCCC’s Gold Key Members represent the best of the best when it comes to exceptional service and exclusive benefits for clients, exhibitors and guests. The Center’s Gold Key memberships with Universal Orlando Resort, SeaWorld Orlando and Walt Disney World greatly enhance meeting planner and attendee experiences offering world-renowned venues, immersive experiences and creative resources for their events. OCCC Events: This fiscal year, the OCCC is projected to host 168 events, 1.7 million attendees, and $2.9 billion in economic impact.  The Center’s top five events during their 2022-2023 fiscal year included:  AAU Jr. National Volleyball Championships 2023 200,000 Attendees $257 Million in Economic Impact MEGACON 2023 160,000 Attendees $205 Million in Economic Impact Open Championship Series 2023 69,500 Attendees $89 Million in Economic Impact Sunshine Classic 2023 42,000 Attendees $54 Million in Economic Impact Premiere Orlando 2023 42,000 Attendees $108 Million in Economic Impact