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Podcast: Voices In Validation
Episode:

The Essentials for Regulatory Compliance and Customer Satisfaction
Category: Science & Medicine
Duration: 00:38:23
Publish Date: 2021-11-09 05:00:00
Description:

This week, Stacey is joined by Kate Coleman to discuss the essentials for building a culture of quality while achieving customer satisfaction. Across life sciences, teams concur that quality, defined by safe, effective, and compliant products, is a prerequisite of the pharmaceutical, biomedical or medical device industry.  The Quality Management System then provides the basic infrastructure needed for defining and validating the documents, processes, procedures, and systems to meet the company's quality objectives. The bi-product?  ̶  the highest customer and patient satisfaction.

Resources from this episode:

Overview of the Quality System Regulation - US Food and Drug

Guidance for Industry Q10 Pharmaceutical Quality System

Can a robust QMS help you achieve customer satisfaction?

About Our Guest:

Kate Coleman, Senior Director/ Principal Consultant at PharmaLex

Kate has worked in Quality roles in the Pharma Industry up to management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a practicing QP, Principal Consultant, a qualified Lead Auditor, and an SME in Risk Management, New Facility Design/Start-Up, QC, and Sterility Assurance.

 

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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