Why Should You Attend:
Global companies must meet different product design documentation for the U.S. and the European Union / Common Market. 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 may soon borrow some features required in the TF/DD. Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both. What are DMRs and DHRs relationship to DHFs, TF/DDs?
This webinar will examine the existing and proposed requirements for the FDA's DHF and the MDD's TF/DD -- how to meet and document them. Their differing purposes / goals, required and desirable contents and areas requiring frequent re-evaluation / update will be discussed. Similarities and differences, and future convergences and trends will be examined. Typical DHF Table of Contents, Technical File or Design Dossier Table of Contents will be presented.
The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed. We will also discuss parallel approaches to development, the Device Master Record / Device History Record "tie in" and differing approaches to file audits by the U.S. FDA and a Notified Body.
Areas Covered in the Webinar:
Who Will Benefit:
All personnel involved in the U.S. FDA-regulated and CE-marking environments. Especially those involved in new medical device / combination product development, line extensions, and incremental product improvements; having to evaluate those changes in light of the DHF, TF/DD, and then document their decisions in harmony with regulations.
John E. Lincoln is principal of J. E. Lincoln and Associates LLC, a consulting company with over 31 years’ experience in U.S. FDA-regulated industries, and 17 years as a full-time consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, design control / design history files, and technical files. He's held positions in manufacturing engineering, QA, QAE, regulatory affairs, to the level of director and VP (R&D). In addition, Mr. Lincoln has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. Mr. Lincoln is a graduate of UCLA.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
PAYMENT METHOD: 100% Secure Transaction