Seminar on The DHF, Technical File and Design Dossier – Similarities, Differences and the Future at Las Vegas, NV

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.
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
Agenda:
Day 1 Schedule
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 Schedule:
Lecture 1:
The EU’s Medical Device Directive
Lecture 2:
The “Essential Requirements” and their documentation
Lecture 3:
The remaining elements of a Technical File / Design Dossier
Lecture 4:
ISO 14971:2012, The Product Risk Management File / Report overview
Lecture 5:
DHF / TF, DD Trends
Lecture 6:
Summary of morning discussion
Lecture 7:
Group activity on 1) The Technical File / Design Dossier, or 2) Essential Requirements
Lecture 8:
Review of group activity and Q&A
Lecture 9:
Summary of morning discussion
Lecture 10:
Course summary discussion

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. 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.

Location: Las Vegas, NV
Venue: Embassy Suites Convention Center Las Vegas, 3600 Paradise Road, Las Vegas, Nevada, 89169, USA

Date: January 14th & 15th, 2016 and Time: 9:00 AM to 6:00 PM

Price: $1,295.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until November 10, Early Bird Price: $1,295.00 from November 11 to January 12, Regular Price: $1,495.00
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Registration Link – http://bit.ly/The-DHF-Technical-File-and-Design-Dossier