Voices In Validation

6 Most common problems in FDA Software Validation and Verification

June 16, 2020 04:01 - 50 minutes - 46 MB

Stacey Bruzzese welcomes David Nettleton to the show. Today, Stacey and David will discuss the 6 most common problems in FDA validation and verification. David is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA compliant applications. He has completed more than 290 mission critical labora...

Managing Quality Control & Variability in Life Sciences

June 09, 2020 04:00 - 46 minutes - 42.3 MB

Stacey Bruzzese welcomes Brian Nunnally, Global Head of Quality Control – A CSL Company, to the show. Today, Stacey and Brian discuss how pharmaceutical manufacturers deal with unexpected variabilities over the lifecycle of their product. What is the current guidance? What are some of the current Control Variation tools and tactics you have seen in the pharmaceutical industry? Are these tools applicable to other industries, say medical devices, as well? Is there a significant change i...

Creating a Culture of Compliance

June 02, 2020 04:00 - 37 minutes - 34.3 MB

Stacey Bruzzese welcomes Garlan Adams to the show to discuss how risk, compliance, and corporate culture matter. What is a culture of compliance? How does human error play into compliance? What are the biggest factors of non-compliance? How ethical fading has impacted corporations How can companies train their employees in compliance? How do companies adhere to compliance protocol? Garlan Adams is an Executive Advisor/Consultant specializing in Legal, Regulatory, Risk, Compliance, and...

Enterprise Information Management Systems and Their Role in Creating Fully Digital Organizations

May 26, 2020 04:00 - 40 minutes - 37.4 MB

Stacey Bruzzese welcomes Ferdi Steinmann & Jennifer Wemstrom from OpenText to the show to discuss Enterprise Information Management and how companies are adapting to a new digital age. Visit: www.opentext.com How can EIM help companies achieve supply chain flexibility? How will EIM solutions help companies adapt to updates to technology? Why are EIM solutions the next step in becoming a smart organization? For companies yet to embrace big data platforms are their benefits in these types...

Pharmaceutical, Device, BioTech: Building a Smart Business. (Part 2)

May 19, 2020 04:00 - 42 minutes - 39.2 MB

Stacey Bruzzese welcomes back Alton Johnson to the show to discuss companies adopting appropriate technologies and the Internet of Things. Reference Documents: Internet of Things Reference Materials - https://www.dropbox.com/s/f69vtmztael36ej/Podcast%20Visual%20References.pdf?dl=0 Guidance – Approval of GXP Documents when Working from Home - https://www.dropbox.com/s/t7t6b532ak6uu4j/Approval%20of%20GxP%20documents%20when%20working%20from%20home%20during%20the%20coronavirus%20%28COVID-19%2...

Pharmaceutical, Device, BioTech: Building a Smart Business. (Part 1)

May 12, 2020 04:00 - 26 minutes - 24.1 MB

Stacey Bruzzese welcomes Alton Johnson to the show to discuss companies adopting appropriate technologies and the Internet of Things. Understanding and developing an interconnected enterprise system What barriers remain for companies that prohibit appropriate implementation? How are businesses having success with “smart manufacturing”? What is the impact for businesses who are just starting to implement IoT? What lessons have some of these companies learned during the covid-19 health cr...

Risk Mitigation in SaaS Solutions w/Chris Wubbolt

May 05, 2020 04:00 - 31 minutes - 29.1 MB

Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing risk mitigation in SaaS Solutions. How SaaS works in GxP environments Can you use vendor supplied software for validation? Can we continue validation with ever changing software? Need to know, Compliant SaaS Provider Responsibilities Can cloud-based systems provide greater agility for companies? Risk factors still present in SaaS How to vet SaaS providers ...

Virtual Auditing during Covid-19

April 28, 2020 04:00 - 38 minutes - 35.1 MB

Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, and John Patterson, Senior Consultant QACV Consulting, to the show. Today, Stacey, John and Chris will be discussing how to run a successful virtual audit during the Covid-19 pandemic. How to factor in audits into a changing schedule during a pandemic What goes into the decision to do a remote audit instead of on-site? What are the regulatory guidelines for virtual audits? What factors need to be considered when y...

Managing data integrity in GCP environment

April 21, 2020 13:27 - 40 minutes - 37.2 MB

Stacey Bruzzese welcomes back Chris Wubbolt, Principal of QACV Consulting, to the show. Today, Stacey and Chris will be discussing how to manage data integrity expectations in GCP environment. Current guidelines that apply to Data Integrity What are the most important data integrity issues? The need for original documents for investigations What should SOP’s entail for firms to manage data risks? Specific regulations for eRecords and eSignatures Use of electronic documents for data int...

Implementing Quality Metrics for Validation w/Ivan Soto

April 14, 2020 03:06 - 29 minutes - 27.1 MB

On today’s episode, Stacey Bruzzese welcomes back Ivan Soto, Director Manufacturing Validation Emergent BioSolutions. Stacey and Ivan talk about the current challenges with the implementation of quality metrics for validation. Stacey and Ivan discuss: What current challenges are companies facing when implementing new metrics? Which metrics have proved to be the most useful? FDA Guidance on Submission of Quality Metrics Data How quality metrics help us understand the lifecycle of equipme...

Supply Chain Management in Times of Uncertainty

April 07, 2020 04:00 - 33 minutes - 30.6 MB

Stacey Bruzzese welcomes Dr. Siegfried Schmitt back to the show. Today, Stacey and Siegfried discuss how the supply chains have been interrupted and what we can do to solve these issues. Supply Chain has been disrupted by covid-19 What exactly happens when supply chains have been changed? Is the drug supply being disrupted by covid-19? When could we see interruptions of drug supplies? Will our current efforts towards fighting covid-19 be enough to prevent breaks in the supply chain? Sh...

COVID-19 and the Increased Demand for Personal Protective Equipment

March 31, 2020 03:00 - 35 minutes - 32.9 MB

Stacey Bruzzese welcomes former FDA investigator Alan Schwartz to talk about how medical device companies are handling the covid-19 pandemic. This is the FDA enforcement policy that is discussed throughout the show. https://www.fda.gov/media/136449/download Topics Include: How can we converse masks and respirators while demand is high? Will the influx of new masks and respirators be up to FDA standards? What is the FDA doing to halt counterfeit respirators? Will the quality of medical ...

Understanding Regulatory Guidelines with Igor Gorsky

March 24, 2020 03:00 - 53 minutes - 49.4 MB

Stacey Bruzzese welcomes Igor Gorsky to the show. Today, Stacey and Igor will be covering the essentials of regulatory guidelines and what goes into writing them. Why are the guidelines so important? What is the process for developing new guidelines? What is superior about the lifecycle approach? Why isn’t complying with Health Authority regulations enough to assure top quality? What would the industry do without Validation? What is a good business model to follow in this space? Igor ...

Annex 1 - What the final draft reveals, and the impact to pharma.

March 17, 2020 03:00 - 44 minutes - 41 MB

Stacey Bruzzese welcomes Dr. Tim Sandle, he is the head of microbiology and sterility assurance at Bio Products Laboratory Limited. Stacey and Tim have a conversation about the European GMP annex 1 and what the final draft reveals. What annex 1 actually is? What are the biggest changes from the previous version to the current document? What are some of the broad reaching impacts that annex 1 will have? What was lacking in previous versions, regarding contamination control? The distincti...

Staying Compliant with Compliant Product Complaint Handling Systems w/Chris Wubbolt

March 10, 2020 03:00 - 34 minutes - 31.3 MB

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 mos...

What is the benefit of contributing to industry publications? with Paul Pluta

March 03, 2020 05:00 - 28 minutes - 26.1 MB

Voices in Validation Why is it important to contribute to industry publications? On this episode, Stacey Bruzzese is joined by Paul Pluta, Editor-In-Chief of the Journals of Validation Technologies and GXP Compliance. Stacey and Paul talk about the need for more contributors to industry publications, not only for industry growth but personal growth as well. Why role did IVT originally serve? How to network between industry personnel and consultants? The differences between JVT ...

8 Essentials of Designing for Manufacturability

February 25, 2020 05:00 - 42 minutes - 39.1 MB

Stacey Bruzzese welcomes Roberta Goode back to the show. Today, Stacey and Roberta will be covering the essentials of designing for manufacturability. Roberta details the 8 essentials of DFM Why is Designing for Manufacturability important for medical device manufacturers? Does standardization of materials help shorten the product development cycle? What’s the next step after determining the practical part count? What is Poka-Yoke? What other points should be considered when scaling...

What’s Trending and Timely in Life Sciences?

February 18, 2020 05:00 - 39 minutes - 36.3 MB

On this episode, Stacey Bruzzese is joined by Karen Ginsbury, President & CEO of PCI Pharmaceutical Consulting Israel. Stacey and Karen talk about what’s new with global systems and regulatory guidelines. What’s new in Quality Management System For Virtual companies, what are their responsibilities in terms of quality systems? What’s the new EU guidance around vendors and responsibility? What will the impact be of new Draft PIC/S recommendations on how to demonstrate the effectiveness o...

Change Management: Beyond the SOP

February 11, 2020 05:00 - 27 minutes - 24.7 MB

On this episode, Stacey Bruzzese welcomes back Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL. They discuss change management and the variety of factors that contribute to successful implementation. What is included in a solid change management SOP? What are the best practices for identifying level of risk to products or systems? What is the best way to handle changes that are urgent, planned or temporary? What best practices exist for pre-approvals to changes...

Change Control for Existing Products

February 04, 2020 05:00 - 41 minutes - 38 MB

Stacey Bruzzese welcomes Alan Golden from Design Quality Consultants. Stacey and Alan have a conversation about a wide variety of change control topics. Alan gives a brief review of the product lifecycle When does change control start and end for a product? What should be included in change control SOP? Is the process of change control vastly different during development and post market? What are the key drivers for post-launch changes? What is unique about the review and documentation...

Data Integrity: Hidden issues and Blind Spots

January 28, 2020 05:00 - 30 minutes - 27.6 MB

On today’s episode, Stacey Bruzzese welcomes Dr. Siegfried Schmitt, Vice President Regulatory and Access at PAREXEL. They discuss how to avoid blind spots when it comes to data integrity. What systems and processes need to be included in my Data Integrity program? Who is responsible for oversight? Siegfried talks about a common misconception about electronic data Are informal notes and brainstorming sessions part of the data integrity equation? Why are so many of us not adhering to our...

Audit Trails and Data Integrity in Pharmaceutical and Life Sciences

January 21, 2020 05:00 - 29 minutes - 27 MB

On today’s episode, Stacey Bruzzese welcomes Ivan Soto, Director Manufacturing Validation for Emergent BioSolutions. They discuss a variety of aspects around the topic of data integrity. Why are we hearing more about audits and audit reviews lately? Ivan talks about the history of audit trail reviews and the current challenges Why are audit trails important to safety, efficacy and reliability or pharmaceuticals and how does that impact data integrity efforts? Why is it important to as...

What Can I Expect During an Audit?

January 14, 2020 05:00 - 39 minutes - 36 MB

On today’s episode, Stacey Bruzzese presents a recording with clips from a mock audit. The mock audit was recorded at a recent IVT conference and was facilitated by Alyce Deegan, Vice President of Data Integrity at Compliance Path LLC. What factors impede a zero-findings review? How can I prepare for an audit review? What can I expect from the inspectors? What kinds of questions do they ask? What is the best way to answer these questions? These questions and more are covered during the...

Testing Automation – The Impact of Increasing Technology on CSV Processes

January 07, 2020 05:00 - 24 minutes - 22.8 MB

On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey back to talk about testing automation and how new technologies impact Computer Systems Validation (CSV). Stacey and Valarie cover a variety of topics: With Parma moving toward AI, IoT, Big Data and more, what are some of the trends specific to Computer Systems Validation? Over the next 12 months, what are some of the greatest obstacles to full integration of technologies for pharma companies? How do manufacturers choose bet...

The intricacies of Computer System Validation in the Pharmaceutical industry

December 31, 2019 05:00 - 31 minutes - 28.6 MB

On today’s episode, Stacey Bruzzese welcomes Chris Wubbolt to talk about validation of manufacturing equipment, processes and computer systems – both hardware and software. Stacey and Chris talk about a variety of topics: Chris gives a brief overview of CSV and why it’s important to the integrity of the product Chris explains why, in an FDA regulated laboratory, CSV is not only concerned with computer hardware and software What is the impact on the Pharma industry of going paperless and ...

Part 3 of Get Your Medical Device to Market in 10 Easy Steps: Product Launch

December 24, 2019 05:00 - 44 minutes - 41.1 MB

On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the final part of our 3-part series. Stacey and Roberta review the steps necessary for a successful product launch. Stacey and Roberta cover a variety of topics: Roberta outlines the steps associated with the final phase prior to product launch Do you still need to be thinking about verification and validation? Is this the right time to be thinking about marketing and branding? What data are ...

Part 2 of Get Your Medical Device to Market in 10 Easy Steps: Design and Development

December 17, 2019 05:00 - 27 minutes - 25.3 MB

On today’s episode, Stacey Bruzzese welcomes Roberta Good, the founder of Goode Compliance for the second part of our 3-part series. Stacey and Roberta dive into the design and development of medical devices. Stacey and Roberta cover a variety of topics: What are the tasks that make up the design and development phase? Do people develop prototypes and when is the right time to do that? How is human factors design applied to engineering medical device? What records and documents need to...

Part 1 of Get Your Medical Device to Market in 10 Easy Steps: Planning

December 10, 2019 05:00 - 41 minutes - 38.4 MB

On today’s episode, Stacey Bruzzese welcomes Roberta Goode, the founder of Goode Compliance. Stacey and Roberta talk about the planning stage to get your medical device to market. Stacey and Roberta cover a variety of topics: Roberta start by outlining the steps covered in this first episode How do we ensure we’re building a product the meets a clinical need? What goes into a product launch plan? What are the considerations if you plan to introduce the product outside of the United Sate...

Women in Science, Technology, Engineering and Mathematics – what’s the real deal?

November 26, 2019 05:00 - 37 minutes - 34.1 MB

On today’s episode, Stacey Bruzzese welcomes Valarie King-Bailey to talk about women in Technology, Engineering and Mathematics. Stacey and Valarie talk about a variety of topics: Valarie talks about her experience at the Women in Validation Empowerment Summit that she attended during Validation Week. Valarie discusses what she believes keeps women from pursuing careers in the engineering field How does Valarie interpret the statistics that show women earn less than men in engineering an...

Pharma 4.0

November 12, 2019 09:02 - 30 minutes - 28.1 MB

On today’s episode, Stacey Bruzzese welcomes Karen Ginsbury to talk about Pharma 4.0. They talk about what Pharma 4.0 is all about. Stacey and Karen talk about a variety of topics: What exactly is Pharma 4.0? Have we reached or passed the tipping point for adoption? What is included in Pharma 4.0? What obstacles does Karen see for implementation of Pharma 4.0? Karen gives a 2-minute explanation of whether Parma 4.0 is affordable and efficient Does Karen think people will be worried th...

Audit Trails – Navigating the Case for Pharma

October 29, 2019 05:00 - 34 minutes - 31.9 MB

On today’s episode, Stacey Bruzzese welcomes Matthew LaPierre to talk about Audit Trails. Matthew is a data integrity industry expert. Stacey and Matthew talk about a variety of topics: Many Pharma companies view audit trails as the Wild West. Matthew talks about the current landscape of audit trails in Pharma In an atmosphere where everything is computerized and we have AI and Big Data, why is the industry having such a challenging time tracking and maintaining audit trails? How do audi...

Quality and Computer Software Assurance

October 22, 2019 05:00 - 32 minutes - 29.6 MB

On today’s episode, Stacey Bruzzese welcomes Steve Thompson, Director Computer Quality Assurance for Science 37. Stacey and Steve talk about a variety of topics: Why is the FDA’s Case for Quality which launched in 2011 just now being implemented on a more widespread level? What challenges are posed by implementation? Steve walks through the core components of the Case for Quality Although it will roll out as a voluntary pilot program, what does Steve see as the progression over the comi...

Building Networking, Learning and Excellence into a Life Science Compliance Conference

October 15, 2019 05:00 - 28 minutes - 26 MB

This week, Stacey talks to Natalia Locatelli. Natalia is a Conference Producer at CBI. They discuss what it takes to put together IVT Network’s Lab Week. Stacey and Natalia cover a variety of topics: How do you find the right content, venue and location for a conference? What is the process for determining the best topics for presentations and workshops? Natalia is currently working on lab week. For more information check out the links below: http://www.cbinet.com/conference/pi19081 ht...

Supplier Oversight and Quality Control for Patient Safety

October 04, 2019 17:19 - 30 minutes - 27.5 MB

On today’s episode, Stacey Bruzzese talks to Dr. Tim Sandle, the Head of Microbiology and Sterility Assurance at Bio Products Laboratory Limited. Stacey and Tim cover a variety of topics: For pharma manufactures, how does fewer employees, smaller inventory, less space and reduced time impact patient safety? What type of supplier oversite is necessary? As supply chains become more and more digital, how does IoT impact processes and programs controlling quality? How do Big Data and Cloud ...