The DHF,Technical File & Design Dossier-Similarities,Diff & The Future (NTZ)
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The DHF,Technical File & Design Dossier-Similarities,Diff & The Future (NTZ)

The DHF,Technical File & Design Dossier-Similarities,Diff & The Future (NTZ...

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Embassy Suites Convention Center Las Vegas

3600 Paradise Road

Las Vegas, NV 89169

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Description

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.

NO REFUNDS ON REGISTRATIONS ALLOWED

NO TRANSFER ON REGISTRATIONS ALLOWED

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Date and Time

Location

Embassy Suites Convention Center Las Vegas

3600 Paradise Road

Las Vegas, NV 89169

View Map

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