NetZealous successfully completes seminar on The DHF, Technical File and Design Dossier

Posted on 2016-01-19 by EPR Network in Pharmaceuticals // 0 Comments

Fremont, CA, January 19, 2016 — /EPR NETWORK/ — NetZealous, a leading provider of regulatory compliance trainings for a wide range of regulated industries, has successfully completed a two-day seminar in Las Vegas on the topic, “The DHF, Technical File and Design Dossier – Similarities, Differences and the Future” on January 14 and 15, 2016. The speaker at this seminar was John E. Lincoln, a senior medical device and regulatory affairs consultant.

This seminar examined the existing and proposed requirements for the FDA’s Design History File (DHF) and its derivate documents, the Device Master Record (DMR) and Device History Record (DHR).

More details about the seminar can be had from http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900288SEMINAR?DHF-technical-file-Las-Vegas-NV

Compliance professionals from various departments and of varied designations received valuable guidance on how they can implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files and Design Dossiers, and other documents, activities and plans.

Mr. Lincoln helped participants understand the ins and outs of Medical Device documentation requirements and implementation. The speaker also covered important areas of relevance to these professionals, such as the European Union’s MDD TF/DD requirements, how to evaluate the documents’ differing purposes or goals, their similarities, and the two different device classification schemes.

He also dealt with required and desirable contents areas requiring frequent re-evaluation/update, typical DHF, 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 Notified-Body review, and the differing approaches to file audits by the FDA and the EU Notified Body.

About the speaker:

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 and 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 have been described in peer-reviewed technical articles and workshops worldwide.

About NetZealous:

NetZealous, a Fremont, CA-registered organization, DBA GlobalCompliancePanel offers a broad range of high quality regulatory and compliance-related professional trainings and services relating to medical devices, pharmaceutical, FDA, clinical trials, laboratory compliance, biologicals, drugs, food and biotechnology.

Satisha Naraharimurthy, CEO of NetZealous, has expressed satisfaction that this being a seminar of such high relevance to regulatory professionals, was very well received and went down well with the participants.

Shahanshah Manzoor, Co-Founder and Chief Marketing Officer at NetZealous, says that this seminar found favor with participating professionals because it was tailored to their regulatory needs and requirements.

Co-Founder and Chief Business Development Officer at NetZealous, Liju Mathew is elated that NetZealous came out with yet another seminar that provided participants just what they were looking for.

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