GlobalCompliancePanel Proudly Presents its Upcoming In-Person Seminar on "The DHF, Technical File and Design Dossier - Similarities, Differences and The Future"
This seminar / workshop will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, their similarities, as well as the two different device classification schemes.
- Las Vegas, NV-AZ (1888PressRelease) August 28, 2014 - 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 Notified-Body reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the U.S. FDA and the EU Notified Body will be discussed.
Reasons to Attend this Valuable Session:
We will consider the following:
- The Design Control requirements of the CGMPs, 21 CFR 820.30
- The Design History File - documenting Product Design Control and its nine elements
- The Device Master Record and the Device History Record
- The EU's Medical Device Directive
- The "Essential Requirements"; and their documentation
- The remaining elements of a Technical File / Design Dossier
- Trends
- Two attendee projects.
The List of Individuals for whom this Course will be benefited:
- Senior and middle management and staff
- Regulatory Affairs
- QA/QC
- R&D
- Production Management
- Manufacturing Engineers
- Process Engineers
- Project Managers
- Vendors, sales and marketing
- Any tasked with medical device development, documentation, and regulatory responsibilities.
Meet your Expert:
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, 17 of which 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 V&V 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 V &V, CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, root cause analysis, and others. John is a graduate of UCLA.
Date: August 28th & 29th 2014 (9 AM to 6 PM EDT)
Location & Venue: Hilton Grand Vacations Suites at the Flamingo Hotel, Las Vegas, Nevada, 89109-4313, USA.
For Registration, Click on the link below:
https://www.globalcompliancepanel.com/control/~product_id=900096SEMINAR
Call our representative TODAY on 1800 447 9407 to have your seats confirmed! Or Email us to support ( @ ) globalcompliancepanel dot com dot
Organizer:
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management.
Our Achievements:
- Over 300 Experts that are Renowned in their Respective Areas
- Successfully Trained more than 20,000 Compliance Professionals
- A Most Comprehensive Portal for Trainings, Industry Updates and Professional Growth
- Having more than 2000 Online Courses
- Successfully Completed more than 170 Seminars in US and Globally.
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