Living together in a group is a strategy many animals use to survive and thrive. And a big part of what makes that living situation successful is listening. In this episode, we explore the collaborative world of the naked mole-rat. Threshold is nonprofit, listener-supported, and independently produced. You can support Threshold by donating today . To stay connected, sign up for our newsletter . Operation frog sound! Send us your frog sounds for an upcoming episode. We want you to go out, listen for frogs and toads, and record them. Just find someone croaking, and hit record on your phone. It doesn’t matter if there’s background noise. It doesn’t even matter if you’re not sure whether or not you’re hearing an amphibian—if you think you are, we would love to get a recording from you. Please also say your name and where you are in the world, and then email the recording to us at outreach@thresholdpodcast.org…
Player FM - Internet Radio Done Right
Checked 15d ago
추가했습니다 eleven 주 전
Risk Revolution에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Risk Revolution 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
Player FM -팟 캐스트 앱
Player FM 앱으로 오프라인으로 전환하세요!
Player FM 앱으로 오프라인으로 전환하세요!
))
Daily Deals
Risk Revolution
모두 재생(하지 않음)으로 표시
Manage series 3643305
Risk Revolution에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Risk Revolution 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
Welcome to Risk Revolution! 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. The hosts for this series are Nuala Calnan, Valerie Mulholland, and Lori Richter.
…
continue reading
20 에피소드
공유
모두 재생(하지 않음)으로 표시
Manage series 3643305
Risk Revolution에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Risk Revolution 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
Welcome to Risk Revolution! 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. The hosts for this series are Nuala Calnan, Valerie Mulholland, and Lori Richter.
…
continue reading
20 에피소드
모든 에피소드
×
R
Risk Revolution
1 22: Role of Culture and Behaviors in Leading Hi-Performing Teams and Delivering Enhanced Performance 1:00:58
1:00:58 
나중에 재생 
나중에 재생 
리스트 
좋아요 
좋아요1:00:58
나중에 재생 나중에 재생 리스트 좋아요 좋아요In this episode, Nuala Calnan chats with Matt Pearson, VP of Quality System & Risk Management at Guardant Health, about how to “switch on” your organisation to proactively manage risk and continuously improve your processes by focusing on creating a culture, where mindsets, behaviors and employee engagement deliver real performance improvement for the business. Matt explains his views on achieving a quality culture, how to strive for workplace engagement, how an organization's structure can lead to fractures, and the three critical enablers for anyone planning to implement sustainable culture change within their organization. SHOW NOTES: ISPE Cultural Excellence Report (2017) https://guidance-docs.ispe.org/doi/book/10.1002/9781946964618 Carol Dweck Mindset book: https://www.amazon.com/Mindset-Psychology-Carol-S-Dweck/dp/0345472322 Access Shane Craddock’s materials: https://shanecradock.com/…
This month on Risk Revolution, Lori Richter chats with Anders Vinther, PhD, the Founder & CEO of Quality Business Administration (QBA). Lori and Anders discuss sustained product quality, consistent product supply, and robust financial performance. Anders shares the Six Traits of a QBL. Anders also shares his thoughts on preserving quality as a company value and the role of engagement in delivering this competitive business advantage. This month’s show notes include: Learn more about the QBA program: https://qbaleaders.com/ QBA program feedback from participants: https://qbaleaders.com/qbl-program-feedback/ Want to apply to be in a cohort? https://qbaleaders.com/certification-program-application-form/ Taking a Stand for Pharmaceutical Quality: The Rise of the Quality Business Leader Deming Institute: https://deming.org/the-deming-philosophy/…
The Risk Revolution Crew is back with an exciting celebratory podcast. Join Nuala, Val, and Lori as they reflect on 20 years of QRM with Prof Kevin O’Donnell. This week’s guest needs almost no introduction to our listeners as he was the rapporteur for the ICH Q9(R1) update, chairs the PIC/s expert circle on QRM and is the Market Compliance Manager with the Irish Regulatory Agency the HPRA. Prof O’Donnell shares his reflections on the QRM journey and what is to come. Listeners should note that Prof O’Donnell’s views are his own and do not necessarily reflect those of the agencies and organizations referenced above. Show Notes ICH Q9(R1) and the supporting training materials can be accessed here: https://www.ich.org/page/quality-guidelines The EMA recommendations draw on lessons learned from the presence of nitrosamines in sartan medicines https://www.ema.europa.eu/en/news/european-regulators-make-recommendations-drawing-lessons-learnt-presence-nitrosamines-sartan-medicines Technical Report No. TR 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages https://www.pda.org/bookstore/product-detail/7852-technical-report-no-68…
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 how 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: James Vesper, MPH, Ph.D. established and is president of LearningPlus, Inc., and has had more than 30 years of 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.…
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 how 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 - 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 the management level for 19 years, covering several platforms including Biologics, Sterile Fill Finish, Vaccines, and Oral Doses. Kate is a practicing QP, Principal Consultant, qualified Lead Auditor, and an SME in Risk Management, New Facility Design/Start-Up, QC, and Sterility Assurance.…
R
Risk Revolution
1 15: Foundations in Quality Risk Management w/Dr. Tim Sandle 53:35
53:35 나중에 재생 나중에 재생 리스트 좋아요 좋아요53:35
나중에 재생 나중에 재생 리스트 좋아요 좋아요In 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 how they perceive and manage risk. 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…
R
Risk Revolution
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 the American Society for Quality '40 under 40' Rising Star in their November 2021 issue of Quality Progress magazine. He is a Fellow of the Royal Society for Arts (FRSA) and a Fellow of the 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).…
This week, Stacey is joined by Nuala Calnan and Valerie Mulholland for an Ask Me Anything session on Quality Risk Management. 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 how they perceive and manage risk. 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.…
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, 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 bringing her 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.…
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 Management 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.…
R
Risk Revolution
1 10: From Dreading the Risk Process to Living the Risk Life 58:33
58:33 나중에 재생 나중에 재생 리스트 좋아요 좋아요58:33
나중에 재생 나중에 재생 리스트 좋아요 좋아요This 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 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 - 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.…
This week, Stacey welcomes back Nuala Calnan and Lori Richter for another episode in the Risk Revolution series. In this episode, we discuss the importance of facilitation in the risk management process and how it leads to the success of a risk assessment. Joining in on this conversation is Tiff Baker, Senior Consultant from ValSource. Resources in this episode: Humble Inquiry - The Gentle Art of Asking Instead of Telling Building Positive Relationships and Better Organizations, (2021) Edgar Schein The Surprising Power of Questions HBR Bias, Heuristics & Risk (Pt. 1) on Risk Revolution | IVT Bias, Heuristics & Risk (Pt. 2) on Risk Revolution | IVT About Our Speakers Lori Richter Lori Richter is the Director of Risk Management at Ultragenyx. She holds a Bachelor of Science degree in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Prior to joining Ultragenyx, she was a consultant for 3 years working with many different companies, including cell and gene therapy as well as large and small molecule, building risk management programs and improvements to quality systems. Before becoming a consultant, she held previous roles such as a Site Risk Manager, leading the development of an Integrated Risk Management program focused on strategic risk and business continuity management. She was also a member of a Global Quality team responsible for the development and deployment of the Quality Risk Management (QRM) program across a global network. She has developed many QRM training modules and delivered training to FDA, Health Canada, and industry teams. Currently, she is an Instructor for the PDA Quality Risk Management Certificate Program. She was an author for TR 54-5, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems” and a chapter author for the book “Principles of Parenteral Solution Validation”. Lori is pursuing a Ph.D. at Technological University Dublin. Nuala Calnan – Nuala is a 25-year veteran of the pharmaceutical industry. Her work as a consultant, academic, author, and commentator is directed toward the development of practical, patient-focused excellence and has included research for FDA(USA), and HPRA(Ireland) patient safety and product quality in the manufacture and distribution of drugs. Nuala works with organizations on transforming organizational culture, delivering more effective end-to-end risk management, implementing knowledge excellence strategies, behavior-based good data governance, and enhancing performance management through people. Nuala co-leads the ISPE Quality Culture Team and is a founding member of the ISPE/PQLI Task Team on Knowledge Management. She is also the Arnold F. Graves Scholar with the Pharmaceutical Regulatory Science Team at TU Dublin, Ireland, where she leads several patient-focused regulatory science research projects at the Masters and Ph.D. levels. Tiff Baker – Tiff Baker, is a Senior Consultant at Valsource. Tiff has been working full-time in the QRM space for over ten years, and in micro roles within the industry before that. She has implemented QRM programs for companies internationally, delivered risk training to industry and regulators alike, developed custom risk tools to meet client needs, and facilitated many risk assessments over the years. She is a co-lead for the Parenteral Drug Association’s Remote Audits and Inspections Task Force as well as an instructor for the PDA Training and Research Institute. In addition, Tiff contributed as an author to ISPE’s Baseline Guide 5 for Commissioning and Qualification to incorporate risk as well as several Points to Consider documents for the PDA.…
R
Risk Revolution
This week, Stacey is joined by Nuala Calnan and Lori Richter to continue their series on Risk Revolution. Rob De La Espriella joins the show to share his insights and expertise on the need for critical thinking and complex problem-solving skills in getting to the root of the matter when we investigate, correct, and prevent failures. Resources from this episode: Root Cause Analysis – A Systematic Approach, JVT Article https://www.ivtnetwork.com/article/root-cause-analysis-%E2%80%93-systematic-approach Addressing the Root Cause, Not the Symptoms: Root Cause Investigations for CAPA – Podcast - https://www.ivtnetwork.com/article/addressing-root-cause-not-symptoms-root-cause-investigations-capa Getting to the Root of the Cause – BioPharm International article - http://www.ivtnetwork.com/sites/default/files/PRE PUB__BP0521_Getting to the root of the matter.pdf Rob De La Espriella is a former nuclear submarine officer and the founder/owner of DLE Technical Services, LLC (DLE), and DLE has been a prime contractor for the Department of Energy since 2012. Rob is one of the leading experts in causal analysis, with over 30 years of experience in leading and facilitating root cause analyses, event investigations, and assessments at commercial nuclear power plants, the US Nuclear Regulatory Commission (NRC), the DOE, the US Department of Defense (DOD), and Engineering firms.…
This week we present Risk Revolution, a monthly series intended to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to continuously seek opportunities to improve and advance how they perceive and manage risk. In this episode, our series coordinators, Lori and Nuala, engage their guest Randy Friedman in an engaging discussion on how bias and heuristics impact risk management, risk identification, and the decisions made during the process. Resources from this episode: ICHQ9 on Quality Risk Management https://www.ema.europa.eu/en/documents/scientific-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en-3.pdf Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part I—The Role of Human Heuristics https://www.ivtnetwork.com/article/strategies-addressing-problems-subjectivity-and-uncertainty-quality-risk-management-exercise Strategies for Addressing the Problems of Subjectivity and Uncertainty in Quality Risk Management Exercises Part II: Risk Communication and Perception Issues https://www.ivtnetwork.com/article/strategies-addressing-problems-subjectivity-and-uncertainty-quality-risk-management-exerci-0…
This week we present Risk Revolution, a monthly series intended to advance the maturity of risk management practices within the industry, by covering topics that challenge quality professionals to continuously seek opportunities to improve and advance how they perceive and manage risk. This week our series coordinators, Lori and Nuala, engage their guest Randy Friedman in an engaging discussion on how bias and heuristics impact risk management, risk identification, and the decisions made during the process. Resources from this Episode: Understanding Problems of Subjectivity and Uncertainty in Quality Risk Management - https://www.ivtnetwork.com/article/understanding-problems-subjectivity-and-uncertainty-quality-risk-management Risk Analysis and Ordinal Risk Rating Scales A Closer Look - https://www.ivtnetwork.com/article/risk-analysis-and-ordinal-risk-rating-scales%E2%80%94-closer-look…
플레이어 FM에 오신것을 환영합니다!
플레이어 FM은 웹에서 고품질 팟캐스트를 검색하여 지금 바로 즐길 수 있도록 합니다. 최고의 팟캐스트 앱이며 Android, iPhone 및 웹에서도 작동합니다. 장치 간 구독 동기화를 위해 가입하세요.
Daily Deals
Daily Deals
Player FM -팟 캐스트 앱
Player FM 앱으로 오프라인으로 전환하세요!
Player FM 앱으로 오프라인으로 전환하세요!
))
