2012 - DHF, DMR, DHR and TF - Regulatory Documents Explained, and Best Practices for Controlling Them - US Seminar 2012 at Pennsylvania

Overview: To be in substantial compliance with FDA and ISO regulations, there are many documents that must be maintained by your firm.

From the earliest phases of the design process all the way through manufacturing and distribution, all aspects of your plans and records must be documented. As well known as these requirements are, that’s the extent to which they are fraught with potential deficiencies. Similarly critical to a compliant document maintenance system is a robust document control system. Without a complete document control system, a company will be out of compliance; without an efficient document control system, a company may be out of business! Don't let your company be that company.

Areas Covered in the Session:

Device Master Record
Description
DMR Contents
DHR - Device History Records
Definition
DHR Requirements ? Regulation
DHR Contents
DHR Purpose ? Manufacturer
DHR Purpose ? FDA
DHR Requirements, Other
Design History File
Regulatory Requirements
Rationale
DHF Contents
Technical File
Structure ? Outline
Structure ? Detail
Essential Requirements Checklist
Risk Analysis
Clinical Requirements
Document Control
Regulatory History
FDA Requirements
ISO 13485 Requirements
Document Approval
Document Control
Document Distribution
Typical Document Control System
Streamlined Document Control Process
How to handle "Minor" changes
Document Retention Change Control for Design Documentation
Design History File
Risk Assessment
Other Change Control Considerations
Management Controls
Purchasing Controls
Production Controls
Who Will Benefit:
Document Control Personnel
R&D Personnel/Management
Regulatory Affairs Management
Senior Management

Contact Information:

Event Coordinator
Toll free: 800-425-9409
Fax: 302-288-6884
Email: support-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Price: $1,495.00
GlobalCompliancePanel
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Wilmington, DE 19801, USA