Jul 31, 2018 - Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each. Tue 31st Jul. Design history file - The DHF is a formal document that is prepared for each medical device. The DHF can be either a collection of the actual documents generated in the product development (PD) process or an index of documents and their storage location.

This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.

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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 Seminar:.

The U.S. FDA's DHF. The EU's MDD and the Technical File / Design Dossier. Design Control 'Over Time' vs.

A Product 'Snapshot in Time'. DHF 'Typical' Contents.

TF / DD Expected Contents. Parallel Approaches to Documentation - Teams. The DMR and DHR - DHF 'Deliverables'. Some Future Trends to Consider. FDA and NB Audit Focus 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.

Senior management. Regulatory affairs. Quality Assurance. Production. Engineering & R&D Instructor Profile: John E. Lincoln, is Principal of J. Lincoln and Associates LLC, a consulting company with over 31 years experience in U.S.

FDA-regulated industries, 17 years as a full-time consultant. John 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, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on all CGMP subjects.

John is a graduate of UCLA. Refund Policy 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.

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After the Final Rule of the Quality System Regulation became effective, a moratorium on enforcement was placed for one year, until the ISO regulations went into effect for design control for medical devices. Since the design control regulations became effective, many warning letters has been issued for failures to fully implement the controlling regulations. This webinar will focus on the records that make up the key regulatory documents, the DHF, DMR and DHR. We will discuss the effect of Change controls on the aforementioned regulatory documents, as any changes in design and production must be proposed, accepted, changes documented and verified to have no unintended consequences on the device. This webinar is beneficial for any professional who is involved with a design effort from the time management releases funding to develop a new device design.

Rick Rutherford Rick Rutherford served as an FDA Investigator for twenty-four years and was a device and biologic certified level II investigator (one of only a handful of investigators Agency wide certified at Level II in more than one program). He served as a Performance Auditor/Trainer for the Agency’s Level II internal certification of investigators and for the Accredited Persons third-party program. He was a device expert for the last several years and served in the International Inspection Cadre. His experience includes greater than 120 international medical device inspections. Since retiring from the US Public Health Service Commissioned Corps and the US Food and Drug Administration, Rick has been active, as a consultant to medical device firms in the US and internationally, performing mock FDA audits, providing training, webinars and consultation on remediation following FDA 483 citations, Warning Letters and consent decrees issued by the FDA. He has a B.S.

In Biology and has been trained in 36 training courses in the full range of FDA regulatory coverage. His experience also includes being a US Navy Hospital Corpsman with hands-on patient care, environmental health issues and has worked in the Oklahoma State Department of Health. Refund Policy Webinar Compliance reserves the right to cancel or reschedule any Webinar/event due to inevitable reasons such as insufficient registrations or circumstances beyond its control. All the attendees will be notified about the cancellation of the event, 24 hours prior to the start time of the Webinar event. The cancelled Webinar, could be rescheduled and a New Date would be promptly intimated to the attendees. In such an event, the attendee can opt for one of the below:. If the New Date is not of convenience, the webinar stream (1-Time Recording) may be availed.

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