Ranked #1

Testing Automation – The Impact of Increasing Technology on CSV Processes
Testing Automation – The Impact of Increasing Technology on CSV Processes
On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey back to talk about testing automation and how new techn... Read more
7 Jan 2020
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24mins
Ranked #2

Data Integrity: Hidden issues and Blind Spots
Data Integrity: Hidden issues and Blind Spots
On today’s episode, Stacey Bruzzese welcomes Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL. Th... Read more
28 Jan 2020
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30mins
Ranked #3

What Can I Expect During an Audit?
What Can I Expect During an Audit?
On today’s episode, Stacey Bruzzese presents a recording with clips from a mock audit. The mock audit was recorded at a ... Read more
14 Jan 2020
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39mins
Ranked #4

Change Management: Beyond the SOP
Change Management: Beyond the SOP
On this episode, Stacey Bruzzese welcomes back Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL. ... Read more
11 Feb 2020
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27mins
Ranked #5

Change Control for Existing Products
Change Control for Existing Products
Stacey Bruzzese welcomes Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about a wide v... Read more
4 Feb 2020
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41mins
Ranked #6

Audit Trails and Data Integrity in Pharmaceutical and Life Sciences
Audit Trails and Data Integrity in Pharmaceutical and Life Sciences
On today’s episode, Stacey Bruzzese welcomes Ivan Soto, Director Manufacturing Validation for Emergent BioSolutions. The... Read more
21 Jan 2020
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29mins
Ranked #7

Managing data integrity in GCP environment
Managing data integrity in GCP environment
Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be ... Read more
21 Apr 2020
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40mins
Ranked #8

Supply Chain Management in Times of Uncertainty
Supply Chain Management in Times of Uncertainty
Stacey Bruzzese welcomes Dr. Siegfried Schmitt back to the show. Today, Stacey and Siegfried discuss how the supply chai... Read more
7 Apr 2020
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33mins
Ranked #9

COVID-19 and the Increased Demand for Personal Protective Equipment
COVID-19 and the Increased Demand for Personal Protective Equipment
Stacey Bruzzese welcomes former FDA investigator Alan Schwartz to talk about how medical device companies are handling t... Read more
31 Mar 2020
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35mins
Ranked #10

Understanding Regulatory Guidelines with Igor Gorsky
Understanding Regulatory Guidelines with Igor Gorsky
Stacey Bruzzese welcomes Igor Gorsky to the show. Today, Stacey and Igor will be covering the essentials of regulatory g... Read more
24 Mar 2020
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53mins
Ranked #11

Annex 1 - What the final draft reveals, and the impact to pharma.
Annex 1 - What the final draft reveals, and the impact to pharma.
Stacey Bruzzese welcomes Dr. Tim Sandle, he is the head of microbiology and sterility assurance at Bio Products Laborato... Read more
17 Mar 2020
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44mins
Ranked #12

Staying Compliant with Compliant Product Complaint Handling Systems w/Chris Wubbolt
Staying Compliant with Compliant Product Complaint Handling Systems w/Chris Wubbolt
On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about staying compliant with compliant product compli... Read more
10 Mar 2020
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34mins
Ranked #13

What is the benefit of contributing to industry publications? with Paul Pluta
What is the benefit of contributing to industry publications? with Paul Pluta
Voices in Validation Why is it important to contribute to industry publications? On this episode, Stacey Bruzzese is... Read more
3 Mar 2020
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28mins
Ranked #14

8 Essentials of Designing for Manufacturability
8 Essentials of Designing for Manufacturability
Stacey Bruzzese welcomes Roberta Goode back to the show. Today, Stacey and Roberta will be covering the essentials of de... Read more
25 Feb 2020
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42mins
Ranked #15

What’s Trending and Timely in Life Sciences?
What’s Trending and Timely in Life Sciences?
On this episode, Stacey Bruzzese is joined by Karen Ginsbury, President & CEO of PCI Pharmaceutical Consulting Israe... Read more
18 Feb 2020
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39mins
Ranked #16

The intricacies of Computer System Validation in the Pharmaceutical industry
The intricacies of Computer System Validation in the Pharmaceutical industry
On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about validation of manufacturing equipment, processe... Read more
31 Dec 2019
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31mins
Ranked #17

Part 2 of Get Your Medical Device to Market in 10 Easy Steps: Design and Development
Part 2 of Get Your Medical Device to Market in 10 Easy Steps: Design and Development
On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the second part of our 3-... Read more
17 Dec 2019
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27mins
Ranked #18

Part 1 of Get Your Medical Device to Market in 10 Easy Steps: Planning
Part 1 of Get Your Medical Device to Market in 10 Easy Steps: Planning
On today’s episode, Stacey Bruzzese welcomes Roberta Goode, the founder of Goode Compliance. Stacey and Roberta talk abo... Read more
10 Dec 2019
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41mins
Ranked #19

Top 3 Trending Topics in Pharmaceuticals – Data Integrity, AI and Leadership
Top 3 Trending Topics in Pharmaceuticals – Data Integrity, AI and Leadership
On today’s episode, Stacey Bruzzese welcomes Felicia Ford-Rice from PAREXEL Consulting to talk the top 3 trending topics... Read more
3 Dec 2019
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43mins
Ranked #20

Women in Science, Technology, Engineering and Mathematics – what’s the real deal?
Women in Science, Technology, Engineering and Mathematics – what’s the real deal?
On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey to talk about women in Technology, Engineering and Math... Read more
26 Nov 2019
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37mins