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

Validation Essentials for Medical Device Manufacturers - IQ, OQ, PQ

 
  February 01, 2021  
     
 
ComplianceOnline, online event
16 March 2021


  • Purpose, scope, and benefits of process validation
  • FDA Expectations, Regulations
  • Lessons learned and enforcement case studies
  • Common problems and easy solutions
  • When to verify and when to validate
  • Steps and Checklists for validation
  • Linkages within your Quality System
  • Master Validation Planning
  • Best Practices
  • Inspection Preparedness
 
 
Organized by: ComplianceOnline
Invited Speakers:

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.


 
Deadline for Abstracts: 14-3-2021
 
Registration: https://www.complianceonline.com/validation-essentials-for-medical-device-manufacturers-webinar-training-705972-prdw?channel=hum-molgen
E-mail: referral@complianceonline.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 © 1995-2021 HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.