This 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...

This 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...

This 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 is...

This 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...

This 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...

This 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...

In 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...

In 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...

This 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...

In 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...

This 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...

In 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...

In 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...

This 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...

This 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...

In 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-enabled...

In 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...

This 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...

This 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 Valesource.   Resources in this episode: Humble Inquiry - The Gentle Art of Asking Instead of Telling Building Positive Relationships and Better Organizations,...

This 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...

This 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...

This 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 enough...

This 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...

This 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...

This week, Stacey is joined by Chris Flask and they discuss how covid has impacted the drug supply chain, how the drug supply chain will look as we return to normal operations, and what the future has in store for this part of the industry. Resources for this Episode: 1. New Bill Enacted Requiring Forecasting of Medical Device and Supply Shortages 2. FDA Drug Product Tracing Requirements – Overview 3. FDA Drug Product Tracing Requirements – The Bill   Chris Flask, Global Business Capability...