Voices In Validation

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 Strauss, CEO and Founder, SciCord

David co-founded SciCord LLC in 2014.  SciCord implemented the first production ELN solution in 2015 and has continued to grow both in functionality and customer base.  SciCord’s solution has evolved to encompass integrated ELN & LIMS functionality with plug-and-play modules preconfigured to automate many laboratory functions.   

Prior to 2014, David created an ELN application for GSK which virtually eliminated paper from the worldwide pre-clinical organization and was credited with a 30% productivity increase. David grew the application over 15 years to service more than 6000 scientists who in turn created over 800,000 experiments. As ELN champion, David was involved and often led the design, development, testing, validation, implementation, and regulatory compliance defense.

David started his career with Merck, working in the lab and then specializing in information and laboratory automation.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

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 Guest:

Patrick Nieuwenhuizen, Director, Senior Consultant with PharmaLex Ireland

Patrick is an experienced Quality professional with a Microbiology & Sterile Manufacturing background amassing expertise over the past 25 years in the Pharmaceutical Industry. Patrick has worked for several global Pharmaceutical and Biotechnology companies across a variety of platforms including Biologics, Sterile Lyo and Fill Finish, Vaccines, and Solid Oral Dose. He is also a qualified lead auditor and SME in Quality Control, Sterility Assurance, New Facility Design/Upgrade, and risk facilitator for Quality Risk Management.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

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 Schardong is privileged to lead Johnson & Johnson’s Technology Quality group responsible for Quality Management System for IT, Software as Medical Device, Externally Facing Digital Assets, external advocacy, quality strategies for emerging technologies, and digital surgery platforms across Medical Devices, Consumer and Pharmaceutical segments worldwide. He has over 25 years of experience in quality engineering, computer software validation, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of the FICSA Group (FDA + Industry Computer Assurance Group).

Disclaimer: This presentation is intended for educational purposes only and does not replace independent professional judgment. Statements of fact and opinions expressed are those of the participant individually and, unless expressly stated to the contrary, are not the opinion or position of Johnson & Johnson or its affiliates.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

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 old friend of the IVT network, Dr. James Vesper. Dr. Vesper will share his unique insights and deep learning on a very interesting aspect of RBDM, Risk Appetite, and the distinction between that and Risk Tolerance. 

About Our Guest:

Dr. Jim Vesper

James Vesper, MPH, Ph.D. established and is president LearningPlus, Inc., and has had more than 30 years experience in the pharmaceutical industry, including 11 years at Eli Lilly and Company. Dr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis. Since 1991, he and his firm, LearningPlus, have worked with pharma/biopharma, device, and blood products organizations around the world consulting on risk management, performance solutions, and custom GMP learning events. He has been a special advisor/consultant to the World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities working as a mentor and instructor for a number of different learning courses. Dr. Vesper has written five books, including Risk Assessment and Risk Management: Clear and Simple, and multiple technical articles. He has a BS in biology (Wheaton College), an MPH (University of Michigan School of Public Health), and a Ph.D. in Education from Murdoch University in Perth, Western Australia. Dr. Vesper may be contacted at [email protected].

Resources From This Episode:

What Are Risk Appetite & Risk Tolerance In Pharma & Medical Devices?

Risk Revolution: The Best of Year One - an Anniversary Episode

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

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 direct result of the coronavirus pandemic, which has impacted the way we think and act on cleaning processes and will continue to do so for the long term.

Here today to talk about clean surface technologies and his invention BIOFoam is Scott Smith, CEO of AquaFlex.

About Our Guest:

Scott Smith, CEO and Founder, AquaFlex

Scott is an inventor named on 11 issued patents and 14 patent-pending applications relating to Open-Cell foam technology (AquaFlex® and bioFOAM™) for testing/remediation of water, surfaces, and air contaminated with dangerous pathogens (e.g., MRSA, COVID-19, Legionella, C. diff), harmful algal blooms and related toxins, oil, and chemicals. Smith holds degrees from Baylor University (1987) and Harvard Business School (1991). For more information go to the following websites:  Truth About Germs, Go bioFOAM, and Go AquaFlex

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

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 begin to harness the data delivered through AI, and further refine the processes around automation, IVT Network strives to bring to light some of the most innovative products and uses for the benefit of the entire life sciences industry.

About Our Guest:

Dr. Peter Small has had an eclectic career, with the common theme being the use of innovation to improve health care. He was chief medical resident at UCSF during the dawn of the HIV epidemic, did pioneering molecular epidemiologic research at Stanford University, and built and ran the TB program for the Bill and Melinda Gates Foundation.

In 2015, he founded the Global Health Institute at Stony Brook University focused on the use of technology to deliver health care in remote Madagascar and Nepal. In 2019, he stepped in as the technical lead of a Gates-funded design-build firm which he recently left to focus on making cough count.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

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 to provide some guidance, both for hiring managers and employees, in navigating this volatile job environment.

About Our Guest:

Justin Bechtel, Founder, and Lead Recruiter, Bechtel Recruiting Group 

Justin began his career in the medical field where he specialized in pediatric and orthopedic physical therapy. Following the completion of clinical placements and doctoral degree, he moved into business development and recruiting, a career that allowed him to recognize his love of personal interaction and helping others more fully. Justin now works with hiring partners and job seekers, to provide an experience second to none, providing an individualized approach to hiring pain points for employers and hiring managers. He also assists job seekers, by simplifying the hiring job search process, coaching job seekers through the stressful process of job hunting. Justin attributes his success to a work ethic centered around quality, accountability, and honesty for both hiring partners and job seekers.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

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 the ICH Q9 Revision with Kate Coleman of PharmaLex. The 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.

Resources from this episode:

ICH Q9 Quality Risk Management Revision 

Link to the new guidance

Understanding the Concept of Formality In Quality Risk ...

Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution

Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare?

Q9R1 presentation

About Our Guest:

Kate Coleman

Kate has worked in Quality roles in the Pharma Industry up to management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Dose. Kate is a practicing QP, Principal Consultant, a qualified Lead Auditor and an SME in Risk Management, New Facility Design/Start Up, QC and Sterility Assurance.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

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 implications on drug development. New knowledge, new ways of working and collaborating, and improved methods of adaptability make this a perfect time to consider evolving our laboratories to meet new demands and maximize patient safety.

About Our Guest:

Brian K Nunnally, Ph.D., Global Head of Quality Control, Seqirus – A CSL Company

Brian is the Head of Quality Control for Seqirus. Being the best quality control unit drives his passion. Prior to this role, he served as the Site Head of Quality for the Holly Springs Seqirus plant. Before joining Seqirus, he worked at Biogen as the Director of Global Stability and also as a Global Regulatory CMC lead. Before joining Biogen, he was in charge of Process Validation for the Pfizer, Sanford, NC site. He is a co-author, with John McConnell, of the book Six Sigma in the Pharmaceutical Industry [2007, Taylor & Francis]. Dr. Nunnally has authored numerous publications in the field of analytical chemistry and operational excellence. He is a member of the CASSS Board of Directors. received two B.S. degrees (1994) from South Carolina Honors College, University of South Carolina, Columbia, and a Ph.D. degree (1998) in chemistry from Duke University, Durham, North Carolina. Prior to taking the Process Validation position, Dr. Nunnally worked in TO&PS Regulatory Affairs. He was responsible for leading the Sanford site's contributions to one of the biggest filings in pharmaceutical history. Prior to joining TO&PS Regulatory, Dr. Nunnally was the Associate Director for GMP Operations in Vaccine Analytical Development at Wyeth. The group he led was responsible for all Reference Standards, Stability, GMP Testing, and Validation for the vaccine candidates Wyeth was developing. Dr. Nunnally has previously worked for Eli Lilly and Company. While at Lilly, he was responsible for leading a Quality Control laboratory devoted to new method development, method optimization, analytical testing for process validation, and analytical testing for manufacturing investigations.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

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 may have accelerated this process for all by about 3 to 4 years. So where are we now as an industry, and what are companies doing to move toward a strategic digital transformation plan?

About Our Guest:

Chinmoy Roy is a seasoned Life Sciences professional with 40 years of hands-on and managerial experience in the life sciences industry. He brings extensive implementation experience in engineering, CCSV (Computerized and Cloud Systems Validation), Data Integrity, and IT compliance, providing the foundation for his consulting and training services. His training in CCSV and Data Integrity has been meticulously developed to disseminate the understanding of industry regulations from fundamental principles of science, engineering, and technology. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu's annual conference for the Asia Pacific, etc. He has worked at or been a consultant for leading US companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson, etc. He has been on Data Integrity discussion panels with FDA inspectors. He travels worldwide to conduct CSV and Data Integrity training. He was one of the early implementors of the world's largest fully paperless manufacturing automation IT system that conforms to 21CFR Part 11 and Data Integrity. He led a team of over 40 engineers and validators to design the system and obtain ‘fit for use’ certification in 1999. His pioneering efforts in implementing that system while employed by Genentech was a precursor to the FDA's issuance of Part 11's Scope and Application guidance in 2003.

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.