Seminar on The DHF, Technical File and Design Dossier - Similarities, Differences and the Future  training seminars presented by Global Compliance Panel register now on FindaSeminar.com

findaseminar logo balls FindaSeminar.com
event search registration and marketing services since 2002
Advanced Search
 
 

** NOTE: All April seminars are live Virtual or Online click to view events.

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

 Email information about this seminar Seminar on The DHF, Technical File and Design Dossier - Similarities, Differences and the Future  by Global Compliance Panel to yourself your manager or associates Email this event... View and register for other training seminars like Seminar on The DHF, Technical File and Design Dossier - Similarities, Differences and the Future  by Global Compliance Panel on FindaSeminar.com Find similar training.. Find and register for other training seminars by Global Compliance Panel on FindaSeminar.com Other seminars from Global Compliance Panel

By:

Global Compliance Panel   

For:

Senior and middle management and staff, Regulatory Affairs, QA/QCR & D, Production Management, Manufacturing Engineers, Process Engineers, Project Managers, Vendors sales and marketing, Any tasked with medical device development, documentation, and regulatory responsibilities

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

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).  (see full course description)

 

 Seminar / Training class dates & locations

 

No seminar dates for this event are currently scheduled.  Please use the seminars search box above or choose one of the following additional training search options to find similar training.

History+Record+Master+Medical+Device+documentation+requirements training seminars workshops conferences online training

Providers course catalog

Find seminars by state

Find seminars by city

Request on site training

Use Advanced Search

NEW  Don't miss training you want to attend

Receive a personal Training Alert when training you want to attend comes to your area. Create a personal Training Alert now  it's Free and only takes a minute!


 

 

 

share this page 

print the agenda print agenda for the Seminar on The DHF, Technical File and Design Dossier - Similarities, Differences and the Future  seminar

 

 

Training Course Syllabus:


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.


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.

Seminar Summary:

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).  (see full course description)

print this agenda print agenda for the Seminar on The DHF, Technical File and Design Dossier - Similarities, Differences and the Future  training seminar

 view dates and locations for this seminar

 

 

 

Custom Search