Technical File Design Dossier 2017 - The DHF, Technical File and Design Dossier - Similarities, Differences and the Future 2017

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. John, a graduate of UCLA, 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.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.
Location: Las Vegas, NV Date: March 2nd & 3rd, 2017 and Time: 9:00 AM to 6:00 PM
Venue: Embassy Suites Convention Center Las Vegas, 3600 Paradise Road, Las Vegas, Nevada, 89169, USA
Price: $1,295.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until January 20, Early Bird Price: $1,295.00 from January 21 to February 28, Regular Price: $1,495.00
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