Innovation in Biopharmaceutical Manufacture (January 2014)

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.

The EU GMP Annex1 Revision 2022 Implementation

This week we share a presentation from Karen Ginsbury. Listen in as she shares her ideas on data integrity lapses, and demonstrates 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 also provides insight on how the industry can advance  despite self-inflicted obstacles.

Data Integrity and Integrating Automation

This week on Voices in Validation, Risk Revolution series coordinator Nuala Calnan and regular contributor Valerie Mulholland discuss the ICH Q9 Revision with Kate Coleman of PharmaLex. The the ICH Q9 revisions were released for public consultation in November and are an improvement over the existing guidance but do leave a few areas that need to be explored further.

Risk Revolution: ICH Q9 Revision, Is it Enough?

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 environment and reliance on digital technologies are we now at a point where the industry is ready to embrace that shift? In this episode we discuss the details on this topic and more, with industry expert Chris Wubbolt.

Paper Versus Electronic Records

Many audits had to be postponed or performed remotely in recent months because of the COVID-19 pandemic. Of course, we have many technical tools at our disposal that allow us to communicate across distances, which should help make these virtual audits as realistic as an on-site audit. That is true to some extent, but there are still many aspects of an audit that simply cannot, or at least not easily, be covered remotely. Today we will discuss the complexities in supply chain management, the expectations for a GDP audit, and deficiencies in distribution processes with our guest Siegfried Schmitt.

Good Distribution Practices and Audit Readiness

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 may have accelerated this process for all by about 3 to 4 years. On this episode of Voices in Validation we speak with our guest Chinmoy Roy about the current state of digital transformation across the pharmaceutical industry, and what companies are doing to move toward a strategic digital transformation plan.

Digital Transformation – Has the Pharma Industry’s ‘Digital Moment’ Arrived?

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, you will hear from Ron Schardong, Valarie King-Bailey, Richard Wedlich, Kurt Moyer, Steve Thompson, Dr. Ross Caputo, and Dr. Paul Pluta.

The team at IVT Network, together with our Esteemed Advisory Board, are proud to announce the recipients of the 2021 IVT Awards. These annual awards recognize the outstanding authors, speakers, podcast guests, and presenters, who keep our audience informed and forward-thinking.

Nominees for the author of the year (both JVT and GXP) are selected by their peers, based on articles published and topics covered, which have been integral to learning and knowledge share across industries throughout the year. The podcast of the year is presented to the individual or panel receiving the greatest number of downloads and listens. Finally, our speakers of the year are selected by vote from attendees of the sessions as the most impactful and engaging in their presentations for the associated event.

IVT Network Awards - 2021

In this episode we invite David Nettleton to be our guest and discuss some of the key topics from the CSV and Software Assurance week panel "The CSA Revolution," Held earlier this spring. The session provides 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 by the panelists.

Computer Systems Validation & Software Assurance - CSA Revolution Commentary -

This week on Risk Revolution, a monthly series of Voices in Validation podcast, we invite two indsutry experts, Nuala Calnana and Karen Ginsbury for a thought-provoking discussion on what disruption, innovation and adaptation offers, to not just shift the paradigm but break the cycle on the ways in which we "have always done things around here."

Disrupting the Risk Paradigm - on Risk Revolution

Patient safety is the primary concern in medical packaging. When we think about packaging, we may immediately  be concerned with straightforward patient communication and transparency. However, patient safety in packaging starts way before the words are ever printed on the package or label. Today we are going to discuss the nuts & bolts around “Selecting medical device packaging materials and sterilization methods to achieve appropriate sterility assurance levels and sterile barrier integrity throughout the labeled shelf life.” We have invited Roberta Goode to help us understand the intricacies of this process.

Sterilization and Sterility Assurance in Medical Device Packaging

Far too often we hear of unanticipated illness and even death due to unexpected effects of ingredients in the foods or medicine we consume. Sometimes these are deliberate, with people consuming more than prescribed or mixing medications. But sometimes these are unintentional, with catastrophic impacts – such as the case of the black licorice. The IVT Network recently published a blog post Unexpected Toxicity From Drug Products on this very topic. Today we will discuss this case and many more as we discover the associated science with two of the authors Bernard Hsu and Paul Pluta.

Death by Licorice? Unexpected Toxicity From Drug Products

Bias in its simplest form is a tendency to lean either in favor of or against a particular thing, while heuristics is an approach to problem solving that uses a limited experience or various shortcuts to arrive at an outcome. Both of these innate tendencies can impact our ability to identify and assess risk, as well as impact our decision making in mitigating or accepting risk.

On this episode of Risk Revolution, an series of Voices in Validation, Lori and Nuala invite Randy Friedman in part one of their discussion on the ways in which bias and heuristics impact risk management, risk identification and the  decisions made during the process.

Bias, Heuristics & Risk (Pt. 1) on Risk Revolution

To err is human, but is human error a justified “cause” in GMP investigations? In pharmaceutical manufacturing,  upwards of 80% of process deviations can be attributed to human error. While regulatory agencies make clear that all deviations, including those caused by human error, must be fully investigated – can we say that we are effectively doing that as an industry? On today's episode of Voices in Validation we speak with Ginette Collazo as we dig deaper into the into the identification and reduction of human error in GMP facilities.

Eliminating Human Error from Your List of Manufacturing Deviations

What is critical data, and why is it important to define it What are the first steps in establishing the criteria desired to identify critical data Once we definite critical data, how do we fully integrate it into our data integrity program How does “critical” data impact validation What are some key considerations in critical data collection, and what are the biggest mistakes made here Given that critical and non-critical data can be stored and maintained in the same database, what special protections of records controls do we need to be mindful of What are the biggest challenges...

Identification and Management of Critical Data

Another Look At Human Error In the Wake of COVID-19

Customized Medicines for Personalized Treatments

Cleaning validation is critical to the pharmaceutical industry, ensuring that risks of contamination, product carry over, and cross contamination are controlled, minimized, and monitored to maintain patient safety and product quality. Today we will discuss the lifecycle approach to cleaning validation, and the importance of creating cGMP approved cleaning programs that encompass the applications, methods and controls necessary for creation and launch of compliant cleaning programs that meet or exceed regulatory expectations.  In this episode we remind listeners about the importance of formalized cleaning programs, and best practices around cleaning activities, sampling and testing.

Life Cycle Approach to Cleaning Validation

On this episode we go back to basics and get some facts straight. All processes and products come with some level of inherent risk. In life sciences, the goal is always to reduce risk as much as possible ensuring patient safety to the maximum extent. This systematic process for the assessment, controls, communication, and review of risks across the product life-cycle is the focus of this new series of podcasts called Risk Revolution. Take a listen as we take a look at risk management in the broader context and get some facts straight about the roles of quality professionals, supply chain, supply chain mapping and crisis planning, risk assessments and much more.

Risk Revolution - Let's Get Some QRM Facts Straight!

Best of BPI: Raymond Colton (February 2014)

Eric Langer - Economics of Large-Scale Media and Buffer Prep

Thomas A. Little - Essentials in QbD

Best of BPI Revisited: Ed Maggio on Protein Aggregation

Derek Masser - Advances in Downstream Process Single-Use Technologies

Blood Centers and Supply Chain - Lisa Shaffer

Todd Kapp - Collaboration Key to Compliance with Single-Use Products in Biomanufacturing

Rasmus Hother Le Fevre - Novo Nordisk Pharmatech

Interviews recorded with speakers in advance of the 2018 BioProcess International Conference & Exhibition.

Popular tracks by Informa Connect Life Sciences - BPI