Why Quality Assurance is More Than Just Following the Rules with Kimberly Wallbank

Life Sciences 360

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1y ago 25:56

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Episode 034: Harsh Thakkar (@harshvthakkar) interviews Kimberly Wallbank (@kimberlywallbank), the Principal Consultant at Quality Systems Services, LLC.
Kimberly addresses the evolution of quality and regulatory practices, particularly the increased focus on risk assessment. She discusses the challenges companies face with compliance and the need for a cross-functional approach, as well as the importance of knowledge sharing, metrics, and making quality accessible to everyone.
Harsh and Kimberly review misconceptions about quality management and stress the importance of understanding the role of quality assurance (QA) professionals in ensuring safety and efficacy. They agree that determining the true root cause of issues requires thorough investigation and consideration of various factors.
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Links:
*Kimberly's LinkedIn
*Quality Systems Services
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Show Notes:
(0:00) Quality management misconceptions in life sciences.
(2:45) Risk assessment and management in industry.
(8:05) Sharing and Utilizing Risk Documents.
(9:33) Determining True Root Cause.
(14:27) Challenges with Compliance.
(18:55) Knowledge Sharing and Metrics.

For transcripts, check out the podcast website - www.lifesciencespod.com

Chapters

1. Why Quality Assurance is More Than Just Following the Rules with Kimberly Wallbank (00:00:00)

2. Risk assessment and management in industry. (00:02:45)

3. Sharing and Utilizing Risk Documents. (00:08:05)

4. Determining True Root Cause. (00:09:33)

5. Challenges with Compliance. (00:14:27)

6. Knowledge Sharing and Metrics. (00:18:55)

82 episodes

#Science #Biology #Harsh Thakkar #Life Sciences #Quality Management #Regulatory Compliance #Biotechnology #Pharmaceutical #Medical Device #Med Tech