Regulatory Compliance

Dhf, Dmr, Dhr And TF – Regulatory Documents Described, And Greatest Practices For Controlling Them

Overview: In which to stay substantial compliance with Fda and ISO rules, there are numerous documents that has to certainly be maintained out of your firm.

Regulatory Compliance Training - Minerva Management Consulting

Within the earliest phases in the design process completely through manufacturing and distribution, every facet of your plans and records ought to be documented. Too known as these needs are, this is actually the extent that they are fraught with potential deficiencies. Similarly vital that you a compliant document maintenance method is a powerful document control system. Without any complete document control system, a company will probably be from compliance without any efficient document control system, a company may be bankrupt! Do not let your business be that company.


Areas Covered inside the Session:

Device Master Record


DMR Contents

DHR – Device History Records


DHR Needs – Regulation

DHR Contents

DHR Purpose – Manufacturer

DHR Purpose – Fda

DHR Needs, Other

Design History File

Regulatory Needs


DHF Contents

Technical File

Structure – Outline

Structure – Detail

Essential Needs Listing

Risk Analysis

Clinical Needs

Document Control

Regulatory History

Fda Needs

ISO 13485 Needs

Document Approval

Document Control

Document Distribution

Typical Document Control System

Streamlined Document Control Process

Regulatory Compliance, Permitting, Approvals & Appeals | Attorneys | Mintz

How to approach “Minor” changes

Document Retention Change Control for Design Documentation

Design History File

Risk Assessment

Other Change Control Factors

Management Controls

Purchasing Controls

Production Controls

Who’ll Benefit:

Document Control Personnel

R&D Personnel/Management

Regulatory Matters Management

Senior Management

Rob Kasoff, RAC, could be the Director of Quality at Byrne Medical, a respected manufacturer of endoscopy products. In this particular position, Rob makes up about supplier management, where he reviews and approves supplier qualification, selection, assessment, and CAPA. Before, Rob spent 13 years at Existence-Tech since the Director of Regulatory Matters, where he was responsible for regulatory compliance of every facet of the conventional system. Rob received his regulatory matters certification in 1996.

Date & Venue:

April 26th and April 27th 2012 at Pennsylvania, Courtyard by Marriott Philadelphia Downtown 8 AM PDT to 5 PM PDT

Ruth Lee
the authorRuth Lee