home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Courses and Workshops
Search  -  prev / next
 
 

Effective Records Management & Document Control for Medical Devices

 
  September 17, 2019  
     
 
Traininng.com LLC, Online
2019-11-05


Overview

 

The document management system for medical device industry should help companies have control over critical activities such as:

  • Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes
  • Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate
  • Creating Action Plans, and verifying their effectiveness
  • Improving efficiencies over the QMS tasks
  • Reducing the risks of manual error
  • Ensuring compliance to 21 CFR Part 11 and immutable audit trail
  • Avoid observations, 483 letters and fines
  • Taking the resource burden out of creating dashboards/ periodic reports

 

Why should you Attend

 

  • Do you have unapproved or outdated documents in circulation?
  • Are your SOP revisions being done in an uncontrolled or inefficient manner?
  • Does your production team use confusing formats that create uncertainty in record-keeping?

In the Medical Device industry, companies must "establish and maintain" documents, procedures, and records. This can involve huge numbers of documents. Without a system for control, this can quickly become burdensome and out of control. This can have disastrous consequences in an FDA inspection.

This webinar will examine the ideas associated with the development and control of quality documentation.

 

Areas Covered in the Session

 

  • QSR and ISO 13485 requirements for document control
  • Description of typical document control system in use
  • How to create uniform documentation that is easy to follow
  • Establish systems that will speed up review of new or revised documents
  • Streamlined document control process
  • Eliminate common formatting problems that create confusion
  • Create more control over controlled documents in circulation
  • Ensure obsolete documents are removed from use

 

Who Will Benefit

 

This webinar will provide valuable assistance to all regulated companies, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Document Control Personnel
  • QA Managers and Personnel
  • Quality Control Personnel
  • Facility Maintenance and Calibration Personnel
  • Manufacturing and Operations Personnel
  • Any employee Involved in Regulatory Audits
  • Executive Management
  • Document Control Clerks
  • Consultants
  • Quality System Auditors
 
 
Organized by: Event Manager
Invited Speakers: Denise Wrestler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consulting, LLC with almost 15 years of experience within FDA-regulated industries including medical device and pharmaceuticals, Ms. Wrestler provides quality, regulatory, and technical expertise to meet individual client needs. Ms. Wrestler agrees with the FDA's "least burdensome approach" and prides herself on providing options and recommendations for ensuring regulations are met without wasting precious company resources.
 
Deadline for Abstracts: 2019-11-03
 
Registration: https://www.traininng.com/webinar/effective-records-management-&-document-control-for-medical-devices--201073live?hum-molgen-Nov-Seo-2019
E-mail: traininngdotcom@gmail.com
 
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995-2019 HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.