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Home > Voices In Validation > Staying Compliant with Compliant Product Complaint Handling Systems w/Chris Wubbolt
Podcast: Voices In Validation
Episode:

Staying Compliant with Compliant Product Complaint Handling Systems w/Chris Wubbolt
Category: Science & Medicine
Duration: 00:34:08
Publish Date: 2020-03-10 03:00:00
Description:

On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about staying compliant with compliant product compliant handling systems.

Stacey and Chris talk about a variety of topics:

  • Overview of the type of systems and the current requirements impacting them
  • How does this integrate into an existing QRM system and does it need to be managed by a separate implementation and monitoring team?
  • What exactly constitutes a “product complaint” under regulatory standards?
  • What are the most common errors or omissions?
  • Outdated systems, Lack of information, and Poorly defined procedures. How can an organization overcome these challenges?
  • What are all of the QMS components?
  • What are three steps they can take to ensure compatibility with existing QRM?
  • What are the best practices for companies to start their QRM?
  • How often should internal audits be done of the product complaint process?

Chris has over 25 years’ experience in regulated industry and has provided compliance, quality assurance and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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