The 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...

The 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...

We 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...

Welcome 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...

As 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...

Trending 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...

This 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...

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 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...

This 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...

This 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...

This 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...

Welcome 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,...

This 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...

This 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...

This 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...

In 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...

In 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 of...

This 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...

This 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...

This 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,...

This 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...

This 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...

This 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...

This 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...