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The DHF, DMR, DHR, and Technical File - Design Dossier 2017

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DoubleTree by Hilton Hotel Las Vegas Airport

7250 Pollock Drive

Las Vegas, NV 89119

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Description

Course "The DHF, DMR, DHR, and Technical File / Design Dossier - With the New ISO 13485:2016 and EU MDR Requirements" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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: October 5th & 6th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: DoubleTree by Hilton Las Vegas Airport 7250 Pollock Drive Las Vegas, NV USA 89119

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 20, Early Bird Price: $1,295.00 From August 21 to October 03, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.

As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

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Date and Time

Location

DoubleTree by Hilton Hotel Las Vegas Airport

7250 Pollock Drive

Las Vegas, NV 89119

View Map

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