Voices In Validation

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 industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. He can be reached at [email protected]

For information or to register for Validation Week 2001 visit: VALIDATION WEEK 2021

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, 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 of patient safety and product quality.

The panelists for this discussion:

Senthil Gurumoorthi - Director IT Gilead Sciences

Cisco Vicenty - Program Manager Case for Quality FDA

Ray Murphy - Principal Engineer Corporate Software Quality Boston Scientific

Ken Shitamoto - Senior Director IT Gilead Sciences

Khaled Moussally - EVP Clients & Regulatory Relations Compliance Group Inc.

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 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 Russell, Valarie King-Bailey, Barkha Saxena, and Beth Kroeger. 

About the panelists:

Divya Yerraguntla

Divya is the host of the Woman to Woman podcast. Divya is also the Vice President, Asset Strategy for Syneos Health. Divya graduated from the Indian Institute of Technology with a Masters in Applied Mathematics. She completed her MBA in Marketing and Strategic Management from Rutgers University.

Barkha Saxena

Barkha is currently the Chief Data Officer for Poshmark. Barkha also serves on the Board of Advisors for Pecan AI. Barkha graduated from the Indian Institute of Technology with a BS and MS in Statistics. She also graduated from the University of California at Santa Barbara with a MA in Statistics and completed her MBA in Strategic Management from The Wharton School.

Beth Kroeger

Beth is a Technical Service Manager. She specializes in cleaning chemistries, processes, and validation. Beth’s background includes over 18 years of experience in finished pharmaceutical and upstream and downstream biotech manufacturing. Beth has a B.S. in Biochemistry.

Erin Russell

Erin is the Founder and CEO of Health Grizzly, a wellness and care navigator helping people find the care they need to improve their health. Erin graduated from Arizona University with a BS in Chemistry. Erin completed her MBA at Harvard Business School.

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 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 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 topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk.

Resources from this episode:

ISPE’s KM Good Practice Guide

T.U. Dublin’s :  A Survey Report on the Current State of QRM and KM Integration

Knowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge Managemen

Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers

Effective Knowledge Transfer During Biopharmaceutical Technology Transfer

Turning Knowledge Into an Asset in Pharmaceuticals – PODCAST

About Our Guest:

Marty Lipa

Marty Lipa, is the Executive Director - Knowledge Management at Merck.  Marty has over 27 years in the biopharmaceutical industry and has led the KM Center of Excellence for Merck manufacturing for the last 11 years.  Marty has recently completed the requirements for his Ph.D. at TU Dublin with an emphasis KM and its connection to QRM.

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 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 Control for Pharmaceuticals and Healthcare, by Tim Sandle

EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products (Draft)

ISO 14698-1: 2003, Cleanrooms and associated controlled environments

FDA Guidelines on Contamination Control

Sterile Drug Products Produced by Aseptic Processing

〈797〉 Pharmaceutical Compounding—Sterile ... - USP

About Our Guest:

Dr. Tim Sandle Ph.D. is a pharmaceutical microbiologist, with over 25 years of experience, who has worked for different healthcare organizations and pharmaceutical companies, in microbiology and broader quality roles. Dr. Sandle currently works for an international sterile products manufacturer and he is additionally a visiting tutor with the University of Manchester (lecturing in pharmaceutical microbiology), a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig), and a supporter of several other societies relating to pharmaceuticals and healthcare, including IVT. Dr. Sandle also serves on several advisory committees and standards boards. Dr. Sandle has written or edited over 25 books, more than 100 book chapters, 125 peer-reviewed papers, and some 400 technical articles. Dr. Sandle is a regular presenter at conferences and webinars, having delivered over 150 presentations.

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 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 science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies, including biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003 and is a regular speaker on industry trends and best practices. Steve received a Bachelor of Science, Computer Information Systems, degree in 1986. He can be reached at [email protected]  

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, 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 cloud-first approach.

About the panel:

Daniel Matlis

Daniel R. Matlis is the Founder and President of Axendia – a trusted advisor to Life-Science and Healthcare executives on business, technology, and regulatory issues.

Dan’s career in the industry spans over 20-years and has included projects in research & development, manufacturing, regulatory compliance, business development and information technology.

Prior to founding Axendia, Dan was General Manager & VP at Stelex (now a GE company) – a leading consultancy to life-science companies.

He started his professional career at Ethicon, Inc., a Johnson & Johnson Company.

Sam Cheemakoti

Sam is the GMP Head at Beiersdorf for the Coppertone Division overseeing GMP compliance of its computer and automated systems. Sam has held positions of increasing responsibility at various Pharmaceutical companies such as Bayer, Merck, and Schering Plough in the areas of Computer Systems Validation, IT Compliance, and Quality Assurance. As a Quality leader with 20+ years in the industry with a demonstrated ability to produce and deploy Part 11 and Data Integrity remediation programs, validation programs, quality systems, strategic initiatives for Quality and Compliance especially under conditions of the consent decree, acquisitions, and divestitures has lent him unique perspectives as a change ambassador and thought leader. Sam earned his MS in Industrial Engineering from Louisiana Tech University and his Project Management credentials from Villanova University. He more recently completed a course on Digital Transformation: Leading People, Data and Technology from the University of Berkeley under their Executive Education Program in order to gain synergies between the two journeys of Digital Transformation and Computer Software Assurance for Quality. 

Paul Hurlocker

Paul is the CTO at Spring Oaks Capital, a technology-driven financial services company whose mission is to reinvent the debt recovery industry by providing a customer-centered user experience and streamlined operations powered by data and machine learning. Paul previously served as the Senior Director and Vice President of the Center for Machine Learning for Capital One. Paul founded Notch, Co and served as the CEO before selling the company to Capital One.

Ron Schardong

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 The Life Sciences Sector https://www2.deloitte.com/content/dam/Deloitte/mx/Documents/human-capital/Talent_2020_LifeSciences.pdf

WE CAN: The Executive Woman's Guide to Career – on Amazon https://www.amazon.com/WE-CAN-Executive-Womans-Advancement/dp/1949635031

WE CAN: The Executive Woman's Guide to Career – on Goodreads https://www.goodreads.com/book/show/43533323-we-can

We Can Rise Community https://wecanrisecommunity.com/

About Our Guest:

Robin Toft is the founder and CEO of Toft Group a ZRG Company, where she combines a deep inside knowledge of the life science industry with a passion for building game-changing management teams. A champion of diverse executive teams, Robin has built a reputation for recruiting women and minorities into top roles and helping the life science industry overcome unconscious bias in hiring. Having successfully sold Toft Group to ZRG Partners, Robin co-founded We Can Rise in 2020, a B-corporation aimed at helping aspiring female executives to confidently reach their potential while achieving balance and collaborating to build healthier companies that change the world. Prior to founding Toft Group in 2010, Robin served 20+ years as a biotech executive. Robin’s first book entitled WE CAN, The Executive Woman’s Guide to Career Advancement, is recognized within the list of 100 Best CEO Books of All Time by BookAuthority and won Gold for Best E-book in the International Business Awards. In the American Business Awards for 2020, Robin won Gold in the three major individual categories of Lifetime Achievement, Maverick of the Year, and Woman of the Year. She also won Gold for Most Innovative Woman of the Year in the Women in Business Awards for 2020.

Robin currently serves on the boards of T2 Biosystems, Syapse, California Life Science Association (CLSA), The Clearity Foundation, and LEAD San Diego. Robin holds a B.S. in Medical Technology from Michigan State. 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 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 topics that challenge quality professionals to seek opportunities to improve and advance how they perceive and manage risk.

Resources from this episode:

12 Inclusive Behaviors - The Kaleel Jamison Consulting

How To Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis

Amy Edmondson – TED TALK, Psychological Safety

About Our Guest:

Amanda McFarland - Senior Consultant at Valsource

Amanda assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. Amanda specializes in creating and implementing risk management training programs, developing custom risk-based strategies, and risk facilitation.

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 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 facilities using real-time analytics for agility in meeting ever-changing markets, and leveraging predictive capabilities to ensure highest levels of quality and control. Valarie will share his perspective on these topics as an industry expert. 

Valarie King-Bailey is the CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) products, and solutions.  OnShore’s product, ValidationMaster™ is the first fully integrated Enterprise Validation Management system on the market.  ValidationMaster™ was recognized by CIO Review Magazine as one of the top 20 most promising technologies for life sciences in 2015. OnShore led the development of the first FDA Validation Toolkit for Microsoft Dynamics AX and Microsoft NAV. Valarie has worked for leading global companies such as QUMAS Limited (Ireland), EMC/Documentum, Abbott Laboratories, and U.S. Steel – South Works.  At QUMAS, an Irish-based software company, she served as Chief Marketing Officer. She was responsible for all global tactical and strategic marketing initiatives and the development of their validation toolkit.  Valarie founded OnShore Technology Group in 2004.  OnShore Technology Group recently won the American Express/Count Me In M3 Award and the Madam C.J. Walker Outstanding Business Award (2008).   She also received a nomination for the Ernst & Young Entrepreneur of the Year award in 2006. Ms. King- Bailey holds an M.B.A. in Information Systems from Keller Graduate School of Management (1985) and a B.S. in Civil and Environmental Engineering from Wisconsin–M Madison (1982).   She is a member of the American Society of Civil Engineers, Society of Women Engineers, National Girls Collaborative Project for STEM education, Regulatory Affairs Professional Society (RAPS), and a U.W. College of Civil Engineering Advisory Board Member. She can be reached at [email protected] 

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.