Voices In Validation

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. 

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, you will hear from series coordinator Nuala Calnan, series regular Lori Richter, Chris Flask, Valerie Mulholland, Amanda McFarland, Rob De La Espriella, and Marty Lipa. 

Segment 1 (00:00): The first clip is taken from episode one in the series and features a discussion on the current challenges of QRM. 

Segment 2 (07:30): The second clip is taken from the episode "Making Confident Risk-Based  Decisions". In this clip, Lori will help define what Risk-Based decisions truly are. 

Segment 3 (15:33): This segment is taken from "Dreading The Risk Life". Amanda McFarland discusses what and why risk can be a dreadful thought for many in the industry.

Segment 4 (20:03): This segment, from the "Getting to the Root of the Matter" episode, looks at complex problem solving with guest Rob De La Espriella.

Segment 5 (30:45): Finally we hear from Marty Lipa about why QRM and KM ended up as separate processes in the industry.

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, 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 prepared for virtual site visits and audits to become the norm.

About Our Guest:

Kelly Simpliciano

Associate Director, Research Development Quality - Clinical Trials Systems & Auditing QA Bristol-Myers Squibb. Kelly has been with Bristol-Myers Squibb since 2003 when she joined as a QA analyst. Kelly achieved her MS, Quality Assurance and Regulatory Affairs in 2018.

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 episode is brought to you by IVT Network's Validation Week.

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 Co’s such as Merck & Co, Eli Lilly & Biogen. Ferdi’s focus is on Life Sciences (LS) strategic planning and industry marketing efforts for enterprise software solutions at OpenText today. He is energized by strategies that deliver on their promises!

www.opentext.com

www.ivtnetwork.com

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, 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 method validation. Alan has more than 30 years of experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018.

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 episode is brought to you by IVT Network's Validation Week.

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 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.

Resources from this episode:

• The ICH Q9 (R1) Guidelines

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. 

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 thinking.

About Our Guest:

Alex Castro

Alex Castro is an aligner of execution to strategy for digital transformation & innovation, best-selling author, and creator/founder of ReM Score™. Alex believes that the gap between ideas (strategy) and execution is a persistent problem that is sidelining too many high-potential digital transformation and innovation growth opportunities.

What will set companies apart in these uncertain economic times are those that reduce the falloff rate of good ideas during execution, seeing more of them create value, resulting in ultimately thriving in the ‘next normal.’

Aligning execution to your ideas for digital transformation and innovation is rooted in removing the biases that have us repeating the same errors in estimating our capabilities to execute.

There is a way to calculate your execution capability for each idea you have, so more of them come to life, and you and your company win more. Alex is a charismatic, intelligent, and knowledgeable guest, with plenty of wisdom to share.

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 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 environment and reliance on digital technologies are we now at a point where the industry is ready to embrace that shift?

About our guest:

Chris Wubbolt

Chris has over 25 years of experience in the regulated industry and has provided compliance, quality assurance, and computer validation consulting services. He remains current in industry trends and requirements and frequently speaks or provides workshops at leading industry conferences and programs. Chris has a master’s Degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering, along with a Six Sigma Black Belt Certification.

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 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 defining a methodology for performing routine checks on cleaning validation procedures.

Resources for this episode:

1. Richard J. Forsyth; Ruggedness of Visible Residue Limits for Cleaning Validation, April 2, 2016, Pharmaceutical Technology

About our guest:

Richard Forsyth

Rich is responsible for customer support for Cleaning Validation and Cleaning related topics.  He has worked as a consultant for several years and prior to that worked in as Associate Director with Merck & Co. for more than three decades.  He has been involved with Cleaning Validation for over 20 years.  Rich has a broad range of analytical experience including methods development and validation as well as formulation development and project management.  Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, PA.

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 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.

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.