2014 - The DHF, Technical File and Design Dossier - Similarities, Differences and The Future

Overview:
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
Why should you attend?
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. 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.
Course Outline:
Day 1 ? Agenda
Lecture 1: The Design Control requirements of the CGMPs, 21 CFR 820.30
Lecture 2: The Design History File - documenting Product Design Control and its nine elements
Lecture 3: The Device Master Record and the Device History Record
Lecture 4: Summary of morning discussion
Lecture 5: Group activity on the 1) The DHF, or 2) The DMR and DHRs
Lecture 6: Review of group activity and Q&A
Day 2 ? Agenda
Lecture 7: The EU's Medical Device Directive
Lecture 8: The "Essential Requirements" and their documentation
Lecture 9: The remaining elements of a Technical File / Design Dossier
Lecture 10: ISO 14971:2012, The Product Risk Management File / Report overview
Lecture 11: DHF / TF, DD Trends
Lecture 12: Summary of morning discussion
Lecture 13: Group activity on 1) The Technical File / Design Dossier, or 2) Essential Requirements
Lecture 14: Review of group activity and Q&A
Lecture 15: Summary of morning discussion
Lecture 16: Course summary discussion
Who Will Benefit:
This workshop will provide valuable assistance to all regulated companies that need to implement, review and/or modify their Device History Files, Device Master Records, Device History Records, Technical Files / Design Dossiers, documents, activities / plan(s). This information addresses Medical Device documentation requirements and implementation. The employees who will benefit include:
? 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
ABOUT SPEAKER ?
John E Lincoln
Consultant, Medical device and Regulatory affairs,
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.
Location: Las Vegas, NV Date: August 28th & 29th, 2014 Time: 9 AM to 6 PM EDT
Venue: Hilton Grand Vacations Suites at the Flamingo
Address: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109-4313, USA
Price: $1,295.00
Discount:
Register now and save $200. (Early Bird)
Until July 15, Early Bird Price: $1,295.00
from July16 to August 26, Regular Price: $1,495.00
Contact Information:
Event Coordinator
Toll free: 1800 447 9407
Fax: 302-288-6884
Email: support-AT-globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.p...
Event Link: http://bit.ly/DHF-TechnicalFile-Design
GlobalCompliancePanel,
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA