Episodes

  • 17: Risk Tolerance & Risk Acceptance

    17: Risk Tolerance & Risk Acceptance
    Nov 13 2022
    This episode originally aired on March 15th, 2022

    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:
    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 jvesper@learningplus.com.
    Show More Show Less
    48 mins
  • 16: ICH Q9 Revision, Is It Enough?

    16: ICH Q9 Revision, Is It Enough?
    Nov 13 2022
    This episode originally aired on February 15th, 2022

    In this episode, Nuala Calnan and Valerie Mulholland 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 - https://www.ivtnetwork.com/article/ich-q9-quality-risk-management-revision
    Link to the new guidance - https://database.ich.org/sites/default/files/ICH_Q9-R1_Document_Step2_Guideline_2021_1118.pdf
    Understanding the Concept of Formality In Quality Risk ... - https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management
    Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution - https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution
    Can ‘Fuzzy Logic’ Be Applied To Risk Management In Pharmaceuticals And Healthcare? - https://www.ivtnetwork.com/article/can-%E2%80%98fuzzy-logic%E2%80%99-be-applied-risk-management-pharmaceuticals-and-healthcare-risk-revolution

    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.
    Show More Show Less
    57 mins
  • 15: Foundations in Quality Risk Management w/Dr. Tim Sandle

    15: Foundations in Quality Risk Management w/Dr. Tim Sandle
    Nov 13 2022
    This episode was originally aired on Decomber 21st, 2021

    In this episode, Nuala Calnan and Valerie Mulholland 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.

    Resources from this episode:
    The ICH Q9 (R1) Guidelines - https://www.dropbox.com/s/1xhsv2v0l2wumd2/ICH_Q9-R1_Documehttps:/www.dropbox.com/s/1xhsv2v0l2wumd2/ICH_Q9-R1_Document_Step2_Guideline_2021_1118.pdf?dl=0nt_Step2_Guideline_2021_1118.pdf?dl=0
    ICH Q9 (R1) Presentation - https://www.dropbox.com/s/23loupxxij00pc3/Published%20ICH_Q9%28R1%29_Step_2_Presentation_2021_1126.pdf?dl=0
    Can Fuzzy Logic Be Applied to Risk Management - https://www.ivtnetwork.com/article/can-%E2%80%98fuzzy-logic%E2%80%99-be-applied-risk-management-pharmaceuticals-and-healthcare
    Critical Thinking #1: Why Pharmaceuticals and Healthcare Needs - https://www.ivtnetwork.com/article/critical-thinking-1-why-pharmaceuticals-and-healthcare-needs-more-critical-thinkers
    Critical Thinking #2: Reading Research Papers - https://www.ivtnetwork.com/article/critical-thinking-2-reading-research-papers
    Critical Thinking #3: Developing Questions to Achieve the Optimal - https://www.ivtnetwork.com/article/critical-thinking-3-developing-questions-achieve-optimal-outcome
    Risk Management, Knowledge Management and the Risk Knowledge Infinity Cycle on Risk Revolution - https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution
    Risk Revolution - Getting to the Root of the Matter - http://www.ivtnetwork.com/article/getting-root-matter-risk-revolution-0
    Show More Show Less
    52 mins
  • 14: Lobsters Can Live Forever

    14: Lobsters Can Live Forever
    Nov 13 2022
    This episode originally aired on November 16th, 2021

    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 Quantitative Method for Modelling
    http://www.ivtnetwork.com/sites/default/files/A%20Quantitative%20Method%20for%20Modelling%20COV...pdf

    Copy of SAQI eQE Newsletter Issue 241 - February 2021
    http://www.ivtnetwork.com/sites/default/files/Copy%20of%20SAQI%20eQE%20Newsletter%20Issue%20241%20-%20February%202021.pdf

    Copy of Quality World - Spring 2021
    http://www.ivtnetwork.com/sites/default/files/Copy%20of%20Quality%20World%20-%20Spring%202021.pdf

    Foundations Of Quality Risk Management: A Practical Approach to Effective Risk-Based Thinking
    https://asq.org/quality-press/display-item?item=H1578

    About our guest:
    Jayet Moon 
    Jayet has earned a master’s degree in biomedical engineering from Drexel University in Philadelphia and is a Project Management Institute (PMI) Certified Risk Management Professional (PMI-RMP). Jayet is also a Chartered Quality Professional in the UK certified by the Chartered Quality Institute (CQI). He is also an Enterprise Risk Management Certified Professional (ERMCP) and a Risk Management Society (RIMS) certified Risk Management Professional (RIMS-CRMP). Jayet was recently awarded the Australian Organization for Quality 'Passion for Excellence' Award and recognized as American Society for Quality '40 under 40' Rising Star in their November 2021 issue of Quality Progress magazine. He is a Fellow of Royal Society for Arts (FRSA) and a Fellow of International Institute for Safety and Risk Management (FIIRSM). He is the author of the book, ‘Foundations of Quality Risk Management’ published by ASQ Quality Press, and holds ASQ CQE, CQSP, and CQIA certifications. Popular articles authored by him on Quality and Risk Management have been published in global trade magazines such as Quality Press (USA), Quality World (UK), Quality Business (Australia and New Zealand), QCI Magazine (India), and eQuality Edge (South Africa).
    Show More Show Less
    44 mins
  • 13: What's hot in QRM?

    13: What's hot in QRM?
    Nov 13 2022
    This episode was originally aired October 19th, 2021

    This week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. 

    Resources from this episode:
    Risk-Based Decision Making: PODCAST RECORDING
    https://www.ivtnetwork.com/article/risk-based-decision-making-podcast-recording
    Risk Management, Knowledge Management and the Risk
    https://www.ivtnetwork.com/article/risk-management-knowledge-management-and-risk-knowledge-infinity-cycle-risk-revolution
    Understanding the Concept of Formality In Quality Risk ...
    https://www.ivtnetwork.com/article/understanding-concept-formality-quality-risk-management
    Quality Management Maturity – A Pilot Program of the FDA
    https://www.ivtnetwork.com/article/quality-management-maturity-%E2%80%93-pilot-program-fda
    ICH Q9 R1 concept document
    https://database.ich.org/sites/default/files/Q9-R1_Concept%20Paper_2020_1113.pdf
    ICH Q14 Concept Paper
    https://database.ich.org/sites/default/files/Q2R2-Q14_EWG_Concept_Paper.pdf
    2021 Updated PIC/s Aide Memoire on Assessment of QRM Implementation
    https://picscheme.org/docview/3823
    Sept 24 2021 Pre-post version of USP 1220 Chapter on Analytical Procedure Life Cycle
    https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-nf-notices/gc-1220-pre-post-20210924.pdf
    QRM: a Case for Convergence:
    https://arrow.tudublin.ie/cgi/viewcontent.cgi?article=1160&context=level3

    About Our Guest:
    Valerie Mulholland
    Valerie Mulholland is the CEO of GMP Services Ltd and is a GMP/Quality Consultant in Europe. She is a practitioner in the area of Quality Risk Management and is researching the topic of Risk-Based Decision Making for a Ph.D. dissertation with the Pharmaceutical Regulatory Science Team in TU Dublin.
    Show More Show Less
    43 mins
  • 12: Disrupting the Paradigm

    12: Disrupting the Paradigm
    Nov 13 2022
    This episode originally aired on September 14th, 2021

    This week, Stacey and Nuala invite a regular IVT contributor and industry disruptor Karen Ginsbury to innovate and revolutionize the future of quality management within the pharmaceutical and biopharmaceutical, and med device sectors. Karen will share her views on ICH Q10 and what must happen next.

    Resources from this episode:
    One Voice of Quality Website - https://prst.ie/1vq/ 
    One-Voice-of-Quality (1VQ) Solutions Part 2 - Podcast Episode | IVT - https://www.ivtnetwork.com/article/one-voice-quality-1vq-solutions-part-2-podcast-episode
    One-Voice-of-Quality (1VQ) Solutions – an Enhanced Science and ... - https://www.ivtnetwork.com/article/one-voice-quality-1vq-solutions-%E2%80%93-enhanced-science-and-risk-based-approach-post-approval-cha
    Elon Musk Hiring Ad - https://www.cnbc.com/2020/02/03/elon-musk-is-recruiting-for-tesla-education-is-irrelevant.html 
    What Is Industry 4.0? - https://www.youtube.com/watch?v=yKPrJJSv94M&t=1s
    ISPE Pharma 4.0 initiative - https://ispe.org/initiatives/pharma-4.0

    About Our Guest:
    Karen Ginsbury
    Karen is a pharmaceutical consultant who brings hands-on experience in designing and implementing environmental control programs within multinational pharmaceutical companies. She started her career in the industry by taking EM samples on the factory floor and brings her own unique perspective to her lively and instructive presentations. Ms. Ginsbury has over twenty years of industry-based experience in quality assurance and compliance and has published a book on compliance auditing for pharmaceutical manufacturers. Ms. Ginsbury is a past holder of IVT’s Presentation of the Year and Web Seminar Presenter of the Year and regularly lectures around the world on pharmaceutical topics.
    Show More Show Less
    56 mins
  • 11: To Infinity and Beyond

    11: To Infinity and Beyond
    Nov 13 2022
    This episode was originally aired on August 17th, 2021

    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.

    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, emphasizing KM and its connection to QRM.
    Show More Show Less
    53 mins
  • 10: From Dreading the Risk Process to Living the Risk Life

    10: From Dreading the Risk Process to Living the Risk Life
    Nov 13 2022
    This episode was originally aired on July 13th, 2021

    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?

    Resources from this episode:

    12 Inclusive Behaviors - The Kaleel Jamison Consulting - https://kjcg.com/s/12InclusiveBehaviors_AR_01202015.pdf

    How To Become A (Better) Facilitator For Risk Assessment And Root Cause Analysis - https://www.pharmaceuticalonline.com/doc/how-to-become-a-better-facilitator-for-risk-assessment-and-root-cause-analysis-0001

    Amy Edmondson – TED TALK, Psychological Safety - https://www.youtube.com/watch?v=eP6guvRt0U0

    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.
    Show More Show Less
    55 mins