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Voices In Validation

Our host, Stacey Bruzzese interviews industry experts from pharma, biotech, med devices and laboratories.

Ranked #1

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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

24mins

Ranked #2

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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

30mins

Ranked #3

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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

39mins

Ranked #4

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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

27mins

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Ranked #5

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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

41mins

Ranked #6

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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

29mins

Ranked #7

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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

40mins

Ranked #8

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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

33mins

Ranked #9

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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

35mins

Ranked #10

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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

53mins

Ranked #11

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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

44mins

Ranked #12

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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

34mins

Ranked #13

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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

28mins

Ranked #14

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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

42mins

Ranked #15

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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

39mins

Ranked #16

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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

31mins

Ranked #17

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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

27mins

Ranked #18

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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

41mins

Ranked #19

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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

43mins

Ranked #20

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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

37mins

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