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.
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
Description
DMR Contents
DHR – Device History Records
Definition
DHR Needs – Regulation
DHR Contents
DHR Purpose – Manufacturer
DHR Purpose – Fda
DHR Needs, Other
Design History File
Regulatory Needs
Rationale
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
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