Voices In Validation
135 episodes - English - Latest episode: about 2 years ago - ★★★★★ - 8 ratingsOur host, Stacey Bruzzese interviews industry experts from pharma, biotech, med devices and laboratories.
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Episodes
Laboratory Review Process and Its Impact on Compliance
April 05, 2022 04:00 - 36 minutes - 28.9 MBThe pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. Poor laboratory practice may yield compliance issues, higher costs, increased cycle time, and delayed product introductions. Avoiding all that means consistent lab review processes and good document controls. Here to review effective laboratory review processes, and their importance to regulatory compliance is David Strauss of SciCord. About Our Guest: David...
EU GMP Annex 1 Revision 2022 Implementation
March 29, 2022 04:00 - 30 minutes - 24.3 MBThe much-discussed revision to the EU GMP Annex 1 is expected to be published early this year, bringing some major changes to drug developers’ current process and manufacturing methods for sterile products. Although the draft revision has been widely shared and commented on, it is still unclear the total impact this document may have across regulated industries. Here to share their perspective on the Annex 1 Revision document is Patrick Nieuwenhuizen from PharmaLex. About Our Guest: Pat...
Critical Thinking, Assessing Risk, and Patient Safety – Setting the Record Straight on CSA
March 22, 2022 04:00 - 41 minutes - 33.4 MBWe have entered an era of accelerated digitalization in Life Sciences. Innovation has been thrust upon many across industries as a need to work remotely, automating tasks and virtual collaborations were necessary during the pandemic. Maintaining this accelerated pace, fully embracing the adoption of technology and automation, is the next hurdle we face. Will CSA get us there? Here to demystify the CSA shift is Ron Schardong, Sr. Director of Quality at J&J. About Our Guest: Ron Schardong...
Risk Revolution: Risk Tolerance & Risk Acceptance
March 15, 2022 04:00 - 48 minutes - 39.2 MBWelcome to Risk Revolution, a monthly series of Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk. This week, series coordinator Nuala is joined once again by Risk Revolution co-hosts, Valerie Mulholland and Lori Richter with another ...
Sustainability without Compromise, the story of BioFoam
March 08, 2022 05:00 - 34 minutes - 27.4 MBAs we begin to harness the data delivered through AI, and further refine the processes around automation, supply chain, new norms around surface contamination and sanitization, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life sciences industry. In drug and device production we are accustomed to concerns about contaminants, and mitigation of impurities, pollutants, and toxins. Heightened awareness around this topic is a di...
Measuring Cough As Clinical Evidence
March 01, 2022 05:00 - 33 minutes - 26.6 MBTrending Technologies in Life Sciences - A Special episode series of Voices in Validation This week, Stacey is joined by Dr. Peter Small, from Hyfe about an AI cough monitor that detects and records every cough and turns that into reliable clinical data. We are working at accelerated speeds to digitalize and automate across pharmaceutical and medical devices. There are unique challenges inherent to emerging technologies in clinical trials development, scale-up, and manufacture. As we b...
The New Norm for Life Sciences Talent Evolution
February 22, 2022 05:00 - 47 minutes - 38.3 MBThis week, Stacey is joined by Justin Bechtel, of Bechtel Recruiting Group. This seems to be the era of the great resignation. Now more than ever in recent history employees have the advantage, and this is true across regulated industries as well. Unfortunately, the amount of training and experience necessary in maintaining GMP standards, delivering quality products, and patient-first service, means this can be an especially challenging environment to recruit, hire and retain. Justin is here...
Risk Revolution: ICH Q9 Revision, Is it enough?
February 15, 2022 05:00 - 58 minutes - 46.6 MBWelcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk. In this episode, Stacey is joined by series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss t...
The Quality Control Response to COVID Disruption in Labs
February 08, 2022 05:00 - 47 minutes - 38.2 MBThis week, Stacey is joined by Brian Nunnally, Global Head of Quality Control, Seqirus. Stacey and Brian discuss updates and insights on laboratory operations since the pandemic began. COVID has changed nearly every facet of society, and many of the changes will be permanent, not returning to the “old ways.” While we often take comfort in the status quo, this pandemic has allowed us many positives too, including better digital capabilities, and a better understanding of technological impli...
Data Integrity and Integrating Automation
February 01, 2022 05:00 - 56 minutes - 45.3 MBThis week, Karen Ginsbury shares her ideas on data integrity lapses, and how automating now can save your business in the future. Karen looks at how the pharmaceutical industry and even society misunderstand what integration truly is. Karen shares her thoughts on how the industry can advance forward despite self-inflicted obstacles. About Our Guest: Karen Ginsbury is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs wit...
Digital Transformation – Has the Pharma Industry’s ‘Digital Moment’ Arrived?
January 25, 2022 05:00 - 1 hour - 51.3 MBThis week, Stacey is joined by Chinmoy Roy to answer some important questions about the current state of digital transformation across the pharmaceutical industry. Digital transformation in the pharmaceutical industry is crucial for better patient care, cost-effectiveness, greater transparency, improved production, and drug development. Across the pharmaceutical industry, companies are at varying stages in the adoption of digital technologies, but it is clear that the recent COVID pandemic m...
Risk Revolution: Best of Year One
January 18, 2022 05:00 - 41 minutes - 33.2 MBWelcome to Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to seek opportunities to improve and advance the ways in which they perceive and manage risk. In this week's episode, we look back at some interesting discussions from the first year in our Risk Revolution series. In these clips,...
Impact of COVID-19 on GXP Inspection Practices
January 11, 2022 05:00 - 38 minutes - 31.2 MBThis week, Kelly Simpliciano hosts a discussion on GXP inspection principles and the changes in processes and expectations stemming from the Covid-19 pandemic. More work than ever is being completed by virtual connections, remote activities, and through systems and processes more reliant on collaborative team efforts and digital technologies. Understanding how these elements affect our inspection preparedness, as well as our day-of-audit activities, is critical to a successful site visit. Be...
Get Smart with your Data
January 04, 2022 05:00 - 38 minutes - 31 MBThis week, Ferdi Steinmann shares his three things you can do to bring intelligence into everything you do. Ferdi breaks down the barriers to intelligence and helps show the path to overcoming the tsunami of data in life sciences. Ferdi covers medical innovations, patient applications, wearables, and the internet of medical things. About Our Guest: Ferdi has nearly 25 years of driving strategy & commercialization efforts in Biotech, Pharma, and Enterprise Software with Fortune 500 Co’s suc...
Integrate Risk into Change Control
December 28, 2021 05:00 - 53 minutes - 42.6 MBThis week, Alan Golden hosts a comprehensive discussion on the changes driven by risk and conversely risk updates that are driven by change as well as risk integration. Alan will share his expertise from over 30 years in the medical device industry. Alan Golden: Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management, and process/test metho...
Risk Revolution: Fuzzy Logic, Risk Management, and Critical Thinking in Pharmaceuticals
December 21, 2021 05:00 - 53 minutes - 42.9 MBIn this episode, Stacey is joined by series coordinator Nuala Calnan and regular contributor Valerie Mulholland to discuss the book "Foundations in Quality Risk Management" with the author, Dr. Tim Sandle. One of the key topics of discussion is dealing with "Fuzzy Logic", and how to manage situations that appear vague, and how that applies to the Pharmaceutical and Healthcare industries. Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the ...
Cognitive Biases in Strategy and Execution
December 14, 2021 05:00 - 48 minutes - 39.2 MBIn this episode, Stacey is joined by Alex Castro to talk about accepting that bias does exist, and strategies for managing and moving beyond biased decision-making practices. Biases is a very interesting topic, and one that we take very seriously in life science manufacturing, as it can impact the quality of the product and add undue risk in this highly regulated environment. Interestingly, many do not consider their personal biases and their impacts on our decision-making and general ways o...
Paper Versus Electronic Records
December 07, 2021 05:00 - 26 minutes - 21.4 MBThis week, Stacey is joined once again by Chris Wubbolt. Stacey and Chris discuss the ins and outs of paper vs. electronic records. In GMP-regulated environments maintaining proper records and documentation is critical to data integrity, regulatory compliance, and GMP best practices. Starting with Part 11 more than two decades ago, we’ve seen an emphasis on good record keeping and a shift to paperless. Still, paper-based systems are prevalent around the world, but given our current environm...
Ruggedness of Visible Residue Limits for Cleaning Validation
November 30, 2021 05:00 - 36 minutes - 29.3 MBThis week, Stacey chats with Rich Forsyth about understanding how the results of testing, and reproducibility of test results under varying conditions allows for consistency across teams and lessens the risk of error in cleaning validation activities. Visual inspection of equipment has always been an important element of the cleaning validation program. Establishing visible residue limits is extremely valuable in setting a baseline for cleanliness, highlighting viewing conditions, and defini...
2021 IVT Awards
November 23, 2021 05:00 - 1 hour - 52.4 MBThis week, Stacey presents the 2021 IVT Awards and interviews the recipients of each award. The awards being presented are Author of the Year for the Journal of GXP Compliance, Author of the Year for the Journal of Validation Technology, Podcast of the Year, Speaker of the Year for Validation Week, Speaker of the Year for Compounding Pharmacy Compliance, Speaker of the Year for Computer Systems Validation and Software Assurance, and the prestigious Chapman Award. During this presentation, y...
Risk Revolution: Foundations in Quality Risk Management
November 16, 2021 05:00 - 44 minutes - 36 MBThis week, Stacey and Nuala sit down with Jayet Moon, author of "Foundations in Quality Risk Management" to review some of the key discussion points from his book and share his views on how risk management “is central to the science of prediction and decision-making;” and how “holistic and scientific risk management creates resilient organizations, which survive and thrive by being adaptable.” Jayet will also explain how lobsters can live forever. Resources from this episode: A Quantita...
The Essentials for Regulatory Compliance and Customer Satisfaction
November 09, 2021 05:00 - 38 minutes - 30.8 MBThis 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 compa...
Transitioning to Risk-Based Monitoring in Clinical Trials
November 02, 2021 04:00 - 35 minutes - 29.8 MBThis week, Stacey is joined by Amanda Coogan to discuss the opportunities and challenges of implementing automated clinical trial management solutions using RBM. Given our current environment, it is no surprise that pharma and device companies are doing everything possible to boost efficiencies. Increasing drug development and production in safe and effective ways, while limiting resources used and dollars spent can be a balancing act. This also applies to clinical trials. Adoption of a risk...
Opportunities & Challenges in Transitioning to Risk-Based Monitoring in Clinical Trials
November 02, 2021 04:00 - 35 minutes - 29.8 MBThis week, Stacey is joined by Amanda Coogan to discuss the opportunities and challenges of implementing automated clinical trial management solutions using RBM. Given our current environment, it is no surprise that pharma and device companies are doing everything possible to boost efficiencies. Increasing drug development and production in safe and effective ways, while limiting resources used and dollars spent can be a balancing act. This also applies to clinical trials. Adoption of a risk...
Unintended Consequences Of USP Compliance
October 26, 2021 04:00 - 33 minutes - 28.5 MBThis week, Stacey is joined by Bryan Prince to talk about the implementation of the 2019 final version of USP 800, and how it is not currently being enforced by most states but quite a few pharmacies around the country are either in the planning and budgeting phase or have already moved forward with construction and being compliant with USP 800 standards. Resources from this episode: USP General Chapter Hazardous Drugs regulations Physical Environment Provisions of USP About our ...
Risk Revolution: What‘s hot in QRM?
October 19, 2021 04:00 - 41 minutes - 33.6 MBThis week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. Valerie answers questions about ICH Q9, ISO Divergence, ICH Q12, Analytical Lifecycle Management, Quality Management Maturity, and much more. Welcome to Risk Revolution, a monthly series of the Voices in Validation podcast, brought to you by the IVT Network. The goal of this series is to advance the maturity of risk management practices within the industry, by coveri...
Top Five Data Integrity Issues
October 12, 2021 04:00 - 48 minutes - 38.6 MBThis week, Stacey and industry expert, Chris Wubbolt, count down the top five data integrity issues when complying with GMP guidance. Data Integrity is a critical element to GMP compliance, and all life science manufacturers need to develop and maintain processes for managing their data, reducing the risk to the integrity of that data, and stored properly. Of course, this is all part of the Regulatory Guidelines which have been in place for years. Still, nearly half of all warning letters co...
Good Distribution Practices and Audit Readiness
October 05, 2021 04:00 - 36 minutes - 28.9 MBThis week, Stacey welcomes back Siegfried Schmitt to the show. Stacey and Siegfried discuss the complexities in supply chain management, the expectations for a GDP audit, and deficiencies in distribution processes. Maintaining product safety and quality during distribution is of utmost importance in the pharmaceutical industry. Just like in other areas of drug manufacture, there is an expected dedication to quality and compliance, which should be present in every aspect of distribution. It i...
A Risk-Based Critical Thinking Approach to Computer Systems Validation
September 29, 2021 14:13 - 57 minutes - 46 MBThis week, Stacey is joined by Ken Shitamoto to explore critical thinking in the systems validation department and share concepts and case history. Most industry folks have heard about CSA and understand the basics behind the shift in priorities. What’s better left to understand is the if’s and how’s around adoption and implementation within our own organizations. A risk-based approach is nothing new. However, the evolution centers on a risk-based approach using critical thinking, with a foc...
Revolutionizing Drug Production: A Shift to Continuous Manufacturing
September 21, 2021 04:00 - 1 hour - 57.8 MBThis week, Stacey is joined by Renee Phillips to discuss the pros and cons of transitioning to a continuous manufacturing system. Batch production is time-consuming yet remains a popular and time-tested method used in the pharma industry today - but some industry leaders, along with the FDA, have taken steps toward or are now contemplating a shift to continuous manufacturing. This means all stages of drug production run through to the final product, without a stop during its production, thus...
Risk Revolution: Disrupting the Paradigm
September 14, 2021 04:00 - 58 minutes - 46.8 MBThis week, Stacey and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical and biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next. Resources from this episode: One Voice of Quality Website One-Voice-of-Quality (1VQ) Solutions Part 2 - Podcast Episode | IVT One-Voice-of-Quality (1VQ) Solutions – an Enhanced Science and ...
CSA Revolution Reaction with David Nettleton
September 07, 2021 04:00 - 49 minutes - 39.6 MBIn this episode, Stacey is joined by David Nettleton to discuss some of the key topics from the recent CSV Virtual Week panel "CSA Revolution." The session "CSA Revolution" was intended to provide a better understanding of the intent and scope of the FDA’s Computer Software Assurance guidance while highlighting CSA’s relationship to other existing regulations. David will share his expertise on some of the ideas and concepts shared in the discussion. About Our Guest: David Nettleton is an ...
CSV Revolution
August 31, 2021 04:00 - 53 minutes - 42.8 MBIn this episode, we will hear an exclusive panel discussion CSV Virtual Event "CSA Revolution." This discussion will provide a better understanding of the intent and scope of the FDA’s Computer Software Assurance guidance while highlighting CSA’s relationship to other existing regulations. Key concepts of CSA include the push for critical thinking and risk-based principles as part of the lifecycle strategy in support of data integrity, and how CSA promotes better use of data for the benefit ...
Women in STEM
August 24, 2021 04:00 - 59 minutes - 47.6 MBThis week, Stacey is joined by Divya Yerraguntla to host a panel discussion on Women in STEM, in partnership with the Woman to Woman podcast. On this panel you will hear conversations about developing an interest in STEM, overcoming barriers in the pursuit of an education in STEM, the obstacles women face when beginning their careers and advancing their careers. The panel takes a look at women's evolving role in STEM and what the future may hold. The panelists on this episode are Erin Russe...
Risk Revolution: To Infinity and Beyond
August 17, 2021 04:00 - 55 minutes - 44.2 MBIn this week's edition of Risk Revolution, Stacey is joined by Nuala Calnan and Marty Lipa to discuss the Risk Knowledge Infinity Cycle. Stacey, Nuala, and Marty also chat about the ways Risk Management and Knowledge Management work together to provide a more effective Quality Management System and the two enablers to building an effective Quality Management System, QRM and KM, which really have been kept separate in the industry but should be working together. Risk Revolution, a monthly se...
Contamination Control Strategy with Dr. Tim Sandle
August 10, 2021 04:00 - 40 minutes - 32.5 MBThis week, Stacey is joined by Dr. Tim Sandle to discuss developing effective contamination control strategies to deal with all aspects of contamination such as particulate, microbial, product carryover, chemical (like cleaning material residues) as well as viral. Dr. Tim Sandle details the common types of contamination, what regulators are seeking from control strategies, the challenges of implementing control strategies, and much more. Resources for this Episode: Biocontamination Cont...
Digital Transformation Reaction w/Steve Thompson
August 03, 2021 04:00 - 1 hour - 49.6 MBIn this episode, Stacey is joined by Steve Thompson to discuss some of the key topics from the recent CSV panel on "Digital Transformation Initiative." The panel shared first-hand experiences of point solutions, and platform transitions, as well as lessons learned from migration to cloud computing and cloud first approaches. Steve will share his expertise on some of the ideas and concepts shared in the discussion. About Our Guest: Steve Thompson has over 20 years of experience in life sci...
CSV: Digital Transformation Initiative
July 27, 2021 04:00 - 1 hour - 49.6 MBIn this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Digital Transformation Initiative" This discussion was moderated by Daniel Matlis and features Sam Cheemokati, Paul Hurlocker, and Ron Schardong. The discussion will be focused on exploring organization-wide digital transformation initiatives. The panel will share their firsthand experiences of point solutions to platforms transitions. And, the best practices when shifting to cloud computing and the...
Working in Life Sciences: Talent Recruitment, Retention & Engagement
July 20, 2021 04:00 - 47 minutes - 37.9 MBThis week, Stacey is joined by Robin Toft to talk about the challenges of attracting and hiring top talent, tactics for building and retaining a workforce, and the technologies that are changing the ways we recruit, hire, and train our teams. Stacey and Robin also discuss which areas are in the most demand, talent management strategies, career path planning, and much more. Resources from this episode: Talent 2020: Surveying The Talent Paradox From The Employee Perspective: The View From Th...
Risk Revolution: From Dreading the Risk Process to Living the Risk Life
July 13, 2021 04:00 - 58 minutes - 46.9 MBThis week our series coordinators, Lori and Nuala, invite their guest Amanda McFarland to chat about Living the Risk Life. How do we take our colleagues on a journey from dreading their participation in the risk process to actually living a work-life and culture that embraces risk management? Risk Revolution, a monthly series of the Voices in Validation, brought to you by the IVT Network. This series aims to advance the maturity of risk management practices within the industry, addressing t...
Quality Systems Monitoring Reaction w/Valarie King-Bailey
July 06, 2021 04:00 - 1 hour - 58.2 MBIn this episode, Stacey is joined by Valarie King-Bailey to discuss some of the key topics from the recent CSV panel on "Excellence and Next-Generation Approaches to Quality System Monitoring." The panel provided reflections on the current landscape, team challenges in data governance programs and policies, understanding sources of bad data, missing data, data consistency and data integrity, as well as the speed of data delivery and defining metrics, and help in establishing digitally-enable...
CSV: Excellence and Next Generation Approaches to Quality System Monitoring
June 29, 2021 04:00 - 59 minutes - 47.5 MBIn this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Excellence and Next-Generation Approaches to Quality System Monitoring." This discussion was moderated by Michelle Miller and features Nuala Calnan, Alyce Deegan, and Daniel Caparros. The discussion will be focused on providing reflections on the current landscape, team challenges in data governance programs and policies, understanding sources of bad data, missing data, data consistency and data inte...
Quality Management Maturity – A Pilot Program of the FDA
June 22, 2021 04:00 - 34 minutes - 27.5 MBThis week, Stacey is joined by FDA members Jennifer Maguire, Nandini Rakala, Alex Viehmann, Carla Lundi, and Lyle Canida. Stacey and the team from the FDA discuss the FDA announced innovative Quality Management Maturity Pilot Programs for Manufacturers of Drug Products and Active Pharmaceutical Ingredients. Results of this pilot program are intended to aid in the creation of a future rating system for drug makers, ranking the maturity of their quality management systems. Such a rating system...
Risk Revolution: Facilitator - Friend or Foe?
June 15, 2021 04:00 - 59 minutes - 48 MBThis week, Stacey welcomes back Nuala Calnan and Lori Richter for another episode in the Risk Revolution series. In this episode, we discuss the importance of facilitation in the risk management process and how it leads to the success of a risk assessment. Joining in on this conversation is Tiff Baker, Senior Consultant from ValSource. Resources in this episode: Humble Inquiry - The Gentle Art of Asking Instead of Telling Building Positive Relationships and Better Organizations, (2021) ...
Drug Naming and Medication Errors
June 08, 2021 04:00 - 48 minutes - 38.7 MBThis week, Stacey is joined by Paul Pluta and Karen Zimm to discuss the particulars of the drug naming process, definitions, and categories for drug names. Karen and Paul present case study scenarios where drug name communications have led to adverse events. A drug may be known by different names during its development and commercial lifecycle. Medication safety problems associated with drug names have long been recognized as a significant problem by healthcare professionals. Whether it’s ...
Combination Products: Successful Product Development & Regulatory Anticipations & Complexities
June 01, 2021 04:00 - 1 hour - 69.2 MBThis week, Stacey is joined by Roberta Goode, who will moderate a discussion on Combination Product Development and some of the challenges that arise in the process. Stacey and Roberta are joined by panelists Becky Leibowitz from Janssen, Kurt Moyer from Pine Lake Laboratories, and Alan Golden from Design Quality Consultants. Resource from this episode: EU Medical Device General Safety and Performance Guidance – MDR ANNEX 1 Guidance FDA 21 CFR Part 4 – Subpart A – Current GMP for Comb...
Functional and Productive Validation During a Pandemic and Beyond
May 25, 2021 04:01 - 42 minutes - 33.7 MBThis week, Stacey welcomes back Ivan Soto to discuss how the pandemic has impacted all businesses in the pharmaceutical and biotechnology industry across every functional area including validation. Downtime due to social distancing requirements, employee illness, and the close of many departments for on-site purposes have had a major impact on productivity and production. Although most companies in the industry have Business Continuity Plans, most of them were not detailed or inclusive enoug...
Risk Revolution: Getting to the Root of the Matter
May 18, 2021 04:00 - 1 hour - 60.9 MBThis week, Stacey is joined by Nuala Calnan and Lori Richter to continue their series on Risk Revolution. Rob De La Espriella joins the show to share his insights and expertise on the need for critical thinking and complex problem-solving skills in getting to the root of the matter when we investigate, correct, and prevent failures. Resources from this episode: Root Cause Analysis – A Systematic Approach, JVT Article https://www.ivtnetwork.com/article/root-cause-analysis-%E2%80%93-systemat...
Risk Revolution - Getting to the Root of the Matter
May 18, 2021 04:00 - 1 hour - 60.9 MBThis week, Stacey is joined by Nuala Calnan and Lori Richter to continue their series on Risk Revolution. Rob De La Espriella joins the show to share his insights and expertise on the need for critical thinking and complex problem-solving skills in getting to the root of the matter when we investigate, correct, and prevent failures. Resources from this episode: Root Cause Analysis – A Systematic Approach, JVT Article https://www.ivtnetwork.com/article/root-cause-analysis-%E2%80%93-systemat...
Ensuring Data Integrity in Virtual Environments
May 11, 2021 04:00 - 41 minutes - 33.6 MBThis week, Stacey welcomes back Chris Wubbolt to get a better understanding of the unique data integrity and validation oversight needed in virtual environments in a post-pandemic world. Stacey and Chris discuss the challenges for businesses of all sizes whether they use a hybrid or remote model. Resources From This Episode: FDA Provides Guidance on Remote Interactive Evaluations COVID-19 - US Food and Drug Administration Guidelines IVT's Annual Computer Systems Validation and Software...