Podcasts about integrated risk management

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Play Episode Listen Later Aug 12, 2021 52:47

Part 2 of my talk with Dr. Gavriel Schneider on Presilience. Presilience is a different way of viewing resilience, in individuals and organizations. Join me as I talk with acknowledged subject matter expert on human centric and Integrated Risk Management, Safety and Security, Dr. Gavriel Schneider. Dr. Schneider has extensive senior level management and leadership experience, and talks to us about how the current compliance-based resiliency approach of organizational leaders needs to change. Presilience is about the ongoing use of skills in a way to better your response to risk, whether it is an opportunity, crisis or emergency. It's not just the commonplace way of utilizing risk management to create a 'response plan'; it allows you and your organization to be better positioned even after you've experienced an adverse situation. It's another real eye-opener of a chat, so don't miss this episode and don't forget to check out Part 1 which aired 2021-07-08!

"Presilience" Part 2 - w/ Dr. Gavriel Schneider

covid-19 business education internet talk crisis radio safety security complex schneider uncertain volatile ambiguous voiceamerica business continuity gavriel integrated risk management

Play Episode Listen Later Aug 12, 2021 52:47

Part 2 of my talk with Dr. Gavriel Schneider on Presilience. Presilience is a different way of viewing resilience, in individuals and organizations. Join me as I talk with acknowledged subject matter expert on human centric and Integrated Risk Management, Safety and Security, Dr. Gavriel Schneider. Dr. Schneider has extensive senior level management and leadership experience, and talks to us about how the current compliance-based resiliency approach of organizational leaders needs to change. Presilience is about the ongoing use of skills in a way to better your response to risk, whether it is an opportunity, crisis or emergency. It's not just the commonplace way of utilizing risk management to create a 'response plan'; it allows you and your organization to be better positioned even after you've experienced an adverse situation. It's another real eye-opener of a chat, so don't miss this episode and don't forget to check out Part 1 which aired 2021-07-08!

Episode 43: Integrated Risk Management

AFERM Risk Chats

Play Episode Listen Later Jul 26, 2021 36:02

Join Paul and Tal as they chat with Simone Reba and Dan Featherly about Integrated Risk Management (IRM)!

tal integrated risk management

"Presilience" w/ Dr. Gavriel Schneider

covid-19 business education internet talk crisis radio safety security complex schneider uncertain volatile ambiguous voiceamerica business continuity gavriel integrated risk management

Play Episode Listen Later Jul 8, 2021 54:29

Presilience is a different way of viewing resilience, in individuals and organizations. Join me as I talk with acknowledged subject matter expert on human centric and Integrated Risk Management, Safety and Security, Dr. Gavriel Schneider. Dr. Schneider has extensive senior level management and leadership experience, and talks to us about how the current compliance-based resiliency approach of organizational leaders needs to change. Presilience is about the ongoing use of skills in a way to better your response to risk, whether it is an opportunity, crisis or emergency. It's not just the commonplace way of utilizing risk management to create a 'response plan'; it allows you and your organization to be better positioned even after you've experienced an adverse situation. We'll also talk about the VUCM world of risk management (Volatile, Uncertain, Complex, Ambiguous). It's a real eye-opener of a chat, so don't miss it!

"Presilience" w/ Dr. Gavriel Schneider

covid-19 business education internet talk crisis radio safety security complex schneider uncertain volatile ambiguous voiceamerica business continuity gavriel integrated risk management

Play Episode Listen Later Jul 8, 2021 54:29

Presilience is a different way of viewing resilience, in individuals and organizations. Join me as I talk with acknowledged subject matter expert on human centric and Integrated Risk Management, Safety and Security, Dr. Gavriel Schneider. Dr. Schneider has extensive senior level management and leadership experience, and talks to us about how the current compliance-based resiliency approach of organizational leaders needs to change. Presilience is about the ongoing use of skills in a way to better your response to risk, whether it is an opportunity, crisis or emergency. It's not just the commonplace way of utilizing risk management to create a 'response plan'; it allows you and your organization to be better positioned even after you've experienced an adverse situation. We'll also talk about the VUCM world of risk management (Volatile, Uncertain, Complex, Ambiguous). It's a real eye-opener of a chat, so don't miss it!

Risk Revolution: Facilitator - Friend or Foe?

Transforming Risk into Confidence: A PwC podcast series

Play Episode Listen Later Jun 15, 2021 59:56

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), 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 a number of 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 prior to 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. 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.

Fireside Chat with PwC and USAA on Integrated Risk Management and enterprise GRC transformation

Play Episode Listen Later Jun 2, 2021 20:12 Transcription Available

In this episode, Seth Rosensweig, Partner and National Digital Risk Compliance and GRC Leader with PwC is joined by Jeff Easley, AVP of Risk & Compliance solutions at USAA and Meris Yee Director in PwC's Risk and Regulatory practice specializing in integrated risk and GRC. In this discussion, they are chatting with Jeff about USAA's strategic Integrated Risk Management and GRC transformation and how it is helping to future proof risk and compliance for the organization.We discuss the following questions:(1:12) - Where did enterprise GRC start at USAA, what triggered the modernization, and where are you now?(1:58) - How are you managing stakeholders and bringing them together to really transform and integrate GRC for the company?(5:25) - What are you seeing in terms of future proofing, and your journey towards sustainability?(11:01) - What are some challenges around data strategy and enabling a sustainable GRC?(15:52) - What are your greatest hopes and greatest fears around this transformation?https://www.pwc.com/us/en/services/consulting/risk-regulatory/podcasts/integrated-risk.html

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Episode 12: The Power of Women in Technology with David Leighton

The Power Shift Podcast

Play Episode Listen Later May 19, 2021 33:32

Episode 012: The Power of Women in Technology with David Leighton David Leighton is Co-founder and President of WITI- Women in Technology International, a global organization founded in 1989. WITI is the premier organization for women who consider technology central to their careers, businesses, and personal lives. David is a creative, highly motivated relationship builder. His network is strong and covers multiple industries. David has launched and led several successful start-up companies. He was formerly the Chairman of Risk Analysis Group- a security strategies firm specializing in Integrated Risk Management, (SM). This is the enterprise-wide application of business principles that protects and streamlines organizations. He is also the founder of Criterion Research, an executive search firm that locates highly specialized technologists and executives for internet, software, semiconductor companies and venture capital firms. He worked closely with the executive team at Borland International from 1989 to 1994 helping them grow to become the #2 software company in the world. He also performed key searches for Transmeta as they were transforming the way chips were built and for Mark Benioff's last project at Oracle before he started Salesforce. Mr. Leighton also co-founded Webolution, Internet infrastructure and custom web-presence consulting firm whose clients include Sun Microsystems, Paramount Pictures, Intel, etc. In this episode, we discuss: · The ‘once in a lifetime' way David started in the field of Women in Technology International (WITI). · What has evolved over time with technology and where are tech companies headed? · What's the real issue when it comes to women's confidence in the workplace? · What's the no lip service way WITI is talking with companies about gender equality and helping their members find jobs in tech? And what does WITI's research show about the benefits of female talent? · What its like to be a white man doing the work of helping companies create cultures where women thrive? · What fascinating opportunities is WITI providing for its international members? Get ready for another powerful episode here on The Power Shift Podcast! Please let me know your thoughts! Connect with David Leighton https://witi.com/ https://she.witi.com/ Connect with Dr. Sharon Melnick Website: https://www.sharonmelnick.com/ LinkedIn: https://www.linkedin.com/in/sharonmelnick/ Twitter: https://twitter.com/DrSharonMelnick Learn more about your ad choices. Visit megaphone.fm/adchoices

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Risk Revolution part 2

Play Episode Listen Later Jan 19, 2021 47:24

Welcome back 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 episode our Risk Revolution team, Lori Richter and Nuala Calnan once again host their colleagues Ghada and Vivian for a robust conversation around risk curious concept, and expand into the why’s and why not’s and the views of this practice under PICs. The group also reviews the need for training and development around risk, formalization of a risk management process, a top-down approach to building culture, and the need for critical thinking and risk-based decision making. Links to Risk Revolution Takeaways:The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-managementKnowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledgeLink to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148Lori 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 PhD at Technological University Dublin. Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and 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), HPRA(Ireland) on 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 a number of patient focused regulatory science research projects at Masters and PhD level. Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics. Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors. 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.

Risk Revolution part 1

Play Episode Listen Later Dec 15, 2020 33:51

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. On this episode our Risk Revolution team, Lori Richter and Nuala Calnan invite their colleagues Ghada and Vivian to help define Risk Culture, discuss everyone’s role in achieving a culture that embraces and learns from risk, highlighting a need for risk identification, covering some risk communication tools, and broadening the understanding around risk-based decision-making processes. Ghada provides some valuable insights into risk excellence from her experience as a team leader on the Global QRM Center of Excellence at Merck, while Vivian provides a needed regulatory framework from here time as an agent at MHRA. Links to Risk Revolution Takeaways:The JVT Special edition on QRM - https://www.ivtnetwork.com/journal-validation-technology/journal-of-validation-technology-3693Role of Senior Leadership in Quality Risk Management - http://www.ivtnetwork.com/article/role-senior-leadership-quality-risk-managementKnowledge As The Currency Of Managing Risk: A Novel Framework To Unite Quality Risk Management And Knowledge... http://www.ivtnetwork.com/article/knowledge-currency-managing-risk-novel-framework-unite-quality-risk-management-and-knowledgeLink to the ISPE Cultural Excellence Report - https://ispe.org/news/cultural-excellence-report PIC/s A Recommended Model for Risk-Based Inspection Planning in the GMP Environment – https://www.picscheme.org/layout/document.php?id=160PIC/s Assessment of Quality Risk Management Implementation - https://picscheme.org/layout/document.php?id=148Lori 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 PhD at Technological University Dublin. Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and 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), HPRA(Ireland) on 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 a number of patient focused regulatory science research projects at Masters and PhD level. Ghada Haddad is an Executive Director at Merck & Company, leading the Global cGMP and Compliance Auditing Organization Prior to this role she was the Head of the Global QRM Center of Excellence at Merck, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries. A board member of PDA, Ghada also chaired the Paradigm Change in Manufacturing (PCMO) initiative which produced a range of technical reports on QRM related topics. Vivian Rowland is currently an Associate Director, for Quality Systems & Compliance at MSD (also known as Merck & Co.) and prior to joining MSD, Vivian was a GMDP Inspector within the Inspectorate at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for over 10 years. Apart from conducting inspections in the UK and overseas, Vivian was the Technical/Operational Lead for Quality Risk Management (QRM) and a Co-ordinating Committee Member at the PIC/S 2nd Expert Circle on QRM, developing advance training courses on QRM for international inspectors. 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.

Cybersecurity & Integrated Risk Management - Top 10 for Trend 2021 - M. James Gomez - BSW #197

Business Security Weekly (Video)

Play Episode Listen Later Nov 24, 2020 32:39

Key Points: Being Strategic is vital and relevant to a successful Cybersecurity Program Understanding Organization Status of controls in real-time is a competitive advantage Cybersecurity tools are tactical – Risk Management is strategic Connecting Cybersecurity to Risk Management ensures to business goals and objectives are maximized to achieve corporate success Visit https://www.securityweekly.com/bsw for all the latest episodes! Show Notes: https://securityweekly.com/bsw197

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Cybersecurity & Integrated Risk Management - Top 10 for Trend 2021 - M. James Gomez - BSW #197

Play Episode Listen Later Nov 23, 2020 32:39

Key Points: Being Strategic is vital and relevant to a successful Cybersecurity Program Understanding Organization Status of controls in real-time is a competitive advantage Cybersecurity tools are tactical – Risk Management is strategic Connecting Cybersecurity to Risk Management ensures to business goals and objectives are maximized to achieve corporate success Visit https://www.securityweekly.com/bsw for all the latest episodes! Show Notes: https://securityweekly.com/bsw197

policy trend privacy cybersecurity compliance governance gomez risk management cso docker ciso paul asadoorian integrated risk management vendorrisk

Energy Leaders Conversations - Giselle Thompson VP Corporate Operations bpTT

Beyond the Rig

Play Episode Listen Later Nov 19, 2020 41:42

Giselle Thompson is the Vice President Corporate Operations for bp Trinidad and Tobago. In this role she holds accountability for the corporate of Communications and Advocacy, Ethics and Compliance, Facilities and Management Services, Security and Integrated Risk Management. In addition to this portfolio, she is also our low carbon sponsor for the bpTT Leadership Team. Giselle is responsible for the management of the company's external facing strategy and reputation. On this episode she offers advice on how young professionals can be more impactful within the industry.

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Integrated Risk Management & Operational Resiliency - Steve Schlarman - SCW #48

Play Episode Listen Later Oct 21, 2020 35:36

2020 has been the perfect storm for risk management planners and practitioners. Steve Schlarman, Director of Product Marketing and GRC Strategist for RSA Archer will provide anecdotes and lessons learned about how Risk management programs have been challenged this year, and how they need to adapt moving forward. This segment is sponsored by RSA Security. Visit https://securityweekly.com/rsasecurity to learn more about them! Visit https://www.securityweekly.com/scw for all the latest episodes! Show Notes: https://wiki.securityweekly.com/scw48

Continuous Integrated Risk Monitoring with Crowe

Risk Recordings with RSA

Play Episode Listen Later Oct 5, 2020 22:02

We’re joined by Josh Reid, GRC Technology Services Leader at Crowe. He discusses how Crowe is elevating Integrated Risk Management practices, moving beyond questionnaire-driven risk information to more consistent, real-time business data coming directly from business systems; then identifying Key Risk Indicators (KRI) from continuous analysis and monitoring of the data. Crowe is a Platinum Sponsor of RSA Archer Summit, a no-fee event that will be held virtually on October 6, 2020. RSA Archer Suite customers, partners, and prospects are all invited to attend.

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Continuous Integrated Risk Monitoring with Crowe

Risk Recordings with RSA

Play Episode Listen Later Oct 5, 2020 22:02

We’re joined by Josh Reid, GRC Technology Services Leader at Crowe. He discusses how Crowe is elevating Integrated Risk Management practices, moving beyond questionnaire-driven risk information to more consistent, real-time business data coming directly from business systems; then identifying Key Risk Indicators (KRI) from continuous analysis and monitoring of the data. Crowe is a Platinum Sponsor of RSA Archer Summit, a no-fee event that will be held virtually on October 6, 2020. RSA Archer Suite customers, partners, and prospects are all invited to attend.

ai continuous integrated crowe josh reid integrated risk management risk monitoring

Quality Risk Management Basics as part of the Quality Management System

Play Episode Listen Later Sep 29, 2020 51:48

This week, Stacey is joined by Lori Richter and Nuala Calnan to talk about risk management and quality management. This is the first episode in the QRM Corner series. We will cover some of the basics of Quality Risk Management in today’s episode and subsequently move on to “deep dives” focused on some of the more intricate and nuanced areas of Risk Management in future episodes.• ICH Q9 Quality Risk Management Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9-quality-risk-management • Annex 1 Manufacture of Sterile Medicinal Products: https://ec.europa.eu/health/sites/health/files/files/gmp/2017_12_pc_annex1_consultation_document.pdf • WHO Risk Management Guidance: https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex2TRS-981.pdf?ua=1 • European Medicines Agency Risk Management Guidance Format: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidance-format-risk-management-plan-rmp-eu-integrated-format-rev-201_en.pdf • European Medicines Agency Risk Management Plans: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/pharmacovigilance/risk-management/risk-management-plans 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 PhD at Technological University Dublin.Nuala Calnan is founder and principal at BioPharm Excel, she holds a PhD in Regulatory Science and 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), HPRA(Ireland) on 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 a number of patient focused regulatory science research projects at Masters and PhD level.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.

Adult Learning Theory and Its Impact on Corporate Learning Environments and Training Programs

The Kobi Simmat Audio Experience

Play Episode Listen Later Jul 28, 2020 63:47

In this episode, Stacey is joined by Lori Richter and James Vesper. They talk about Adult Learning Theory and its impact on corporate training. 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 PhD at Technological University Dublin. Lori Richter’s Articles On The Topic:Understanding Adult Learning Principles, CGMP Training Modalities ...Applying Adult Learning Principles In CGMP TrainingBuilding Effective CGMP Training Designed For The Adult Learner James Vesper has worked in the pharmaceutical industry for more than 35 years, starting out at Eli Lilly and Company where his last position was leading the GMP training initiative. For 24 years, he was President of Learning Plus, a training consultancy and, in 2017, he joined ValSource as Director of Learning Services. Dr. Vesper has authored numerous books, book chapters, articles, and also speaks and teaches at international conferences and workshops, as well as consults for the World Health Organization (WHO). He received his PH.D. in education from Murdoch University, Perth, Australia. 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.

EP #71 - City Planning & Architecture for the Pandemic - Roverto Moris

COVIDCalls

Play Episode Listen Later Jun 29, 2020 77:06

Today, we have a discussion about city planning & architecture for a pandemic with Roberto Moris.Roberto MORIS is an architect who graduated from the Pontifical Catholic University of Chile, with a Master in City Design and Social Sciences, London School of Economics, and Ph.D. student in Civil Engineering, University of Granada. He is an expert on integrated planning, carrying capacity models, sustainability, and resilience. He has worked with the UNDP, World Bank, and IADB. He was Technical Secretary of the Cities and Territory Ministers Committee and National Director of Urban Projects at the Chilean Ministry of Housing and Urban Development. He was responsible for the creation of the first Urban Planning academic program in Chile and founder of the Chilean Planners Network. He is a professor at the School of Architecture and the Institute of Urban and Territorial Studies. He was Principal Investigator of the National Research Center for Integrated Risk Management, Director of Cities Observatory UC, and Director of Plans and Urban Projects Program UC. His research has focused on developing instruments to assist decision-making through methodologies and management models that integrate people into common objectives.

Integrated Risk Management

Play Episode Listen Later Jun 3, 2020 61:04

Integrated Risk Management . Follow and subscribe to: Best Practice Website: https://goo.gl/uJTioQ Facebook: https://goo.gl/VOJfKZ LinkedIn: https://goo.gl/dZmlTr Youtube: https://goo.gl/8SVD9E Instagram: @bestpractice.biz TikTok: bestpracticebiz

integrated risk management

Pixie Dust - SCW #18

Security and Compliance Weekly (audio)

Play Episode Listen Later Feb 19, 2020 61:00

This week, we welcome Jeff Recor, Global IRM Lead at Accenture, to talk about how Integrated Risk Management is the New GRC! Jeff was scheduled to be part of the 'Security vs. Compliance' Roundtable (https://securityweekly.com/shows/security-vs-compliance-psw-632-2/) recorded on Dec. 19, 2019, but got snowed out! Show Notes: https://wiki.securityweekly.com/SCWEpisode18 Visit https://www.securityweekly.com/scw for all the latest episodes! Follow us on Twitter: https://www.twitter.com/securityweekly Like us on Facebook: https://www.facebook.com/secweekly

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Pixie Dust - SCW #18

Paul's Security Weekly

Play Episode Listen Later Feb 19, 2020 61:00

This week, we welcome Jeff Recor, Global IRM Lead at Accenture, to talk about how Integrated Risk Management is the New GRC! Jeff was scheduled to be part of the 'Security vs. Compliance' Roundtable (https://securityweekly.com/shows/security-vs-compliance-psw-632-2/) recorded on Dec. 19, 2019, but got snowed out! Show Notes: https://wiki.securityweekly.com/SCWEpisode18 Visit https://www.securityweekly.com/scw for all the latest episodes! Follow us on Twitter: https://www.twitter.com/securityweekly Like us on Facebook: https://www.facebook.com/secweekly

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Integrated Risk Management is the New GRC - Part 2 - Jeff Recor - SCW #18

Play Episode Listen Later Feb 19, 2020 29:17

Continuation of the discussion with Jeff Recor about integrated risk management. Visit https://www.securityweekly.com/scw for all the latest episodes! Show Notes: https://wiki.securityweekly.com/SCWEpisode18

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Integrated Risk Management is the New GRC - Part 1 - Jeff Recor - SCW #18

Play Episode Listen Later Feb 18, 2020 31:48

Jeff was scheduled to be part of the 'Security vs. Compliance' Roundtable (https://securityweekly.com/shows/security-vs-compliance-psw-632-2/) recorded on Dec. 19, 2019 but got snowed out. He finally gets to enlighten us on integrated risk management. Visit https://www.securityweekly.com/scw for all the latest episodes! Show Notes: https://wiki.securityweekly.com/SCWEpisode18

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Episode 24: Sparking an IRM 4.0 Discussion

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Play Episode Listen Later Dec 12, 2019 15:19

In this edition of the SpheraNOW podcast, Ellen Bremseth, Spera's marketing communications manager, talks with James Tehrani, Spark’s editor in chief about the fall/winter issue of Spark magazine. They talk about the cover story, which discusses Integrated Risk Management 4.0 (IRM 4.0), the Robert Irvine Interview and much more. They also talk about how the Sphera Litter Challenge got started and how you can take part. #SparksAreFlying

Integrated Risk Management for CEOs - Mathieu Gorge - SCW #9

Play Episode Listen Later Dec 4, 2019 37:50

Mathieu Gorge is the CEO at Vigitrust. The approach that business leaders need to take in developing payment risk strategies, linking, PCI, ISO, GDPR, CCPA, SCA. Visit https://www.securityweekly.com/scw for all the latest episodes! Show Notes: https://wiki.securityweekly.com/SCWEpisode9

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Episode 22: Itching to Innovate

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Play Episode Listen Later Dec 2, 2019 18:37

Coinciding with the fall 2019 Spark cover story on Integrated Risk Management 4.0, James Tehrani, Spark’s editor-in-chief, speaks with Jerry Shaughnessy, Sphera’s chief architech, about his background, where companies go wrong with their innovation strategies and how technology will continue to change the game for risk mitigation strategies. Don’t forget to visit sphera.com/spark and register to receive notifications about when this and future issues come out.

Episode 19: Where Do We Go With MRO?

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Play Episode Listen Later Dec 2, 2019 8:15

Coinciding with the fall 2019 Spark cover story on Integrated Risk Management 4.0, James Tehrani, Spark's editor-in-chief , speaks with David Stroud, Sphera’s vice president of MRO sales, about his background, how Maintenance, Repair & Operations fits into an Integrated Risk Management strategy and what the future might hold. Don’t forget to visit sphera.com/spark and register to receive notifications about when this and future issues come out.

RMA and FCInsight to Conduct Integrated Risk Management Survey

The Risk Management Association

Play Episode Listen Later Dec 2, 2019 8:20

RMA and FCInsight are partnering to conduct the first ever survey to study the maturity of integrated risk management.

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Through the Roof - SCW #1

Paul's Security Weekly

Play Episode Listen Later Nov 7, 2019 72:06

This week, we bring to you our brand new show, Security and Compliance Weekly, hosted by Jeff Man, and Co-Hosted by Scott Lyons, Josh Marpet, and Matt Alderman! In the first segment, Jeff and the hosts talk about PCI and how it affects the state of the union! In the Security and Compliance News, Important security notice about your DoorDash account, How PCI DSS compliance milestones can be a GDPR measuring stick, Companies vastly overestimating their GDPR readiness, only 28% achieving compliance, When Compliance Isn't Enough: A Case for Integrated Risk Management, and much more! Show Notes: https://wiki.securityweekly.com/SCWEpisode1 Visit https://www.securityweekly.com/scw for all the latest episodes! Follow us on Twitter: https://www.twitter.com/securityweekly Like us on Facebook: https://www.facebook.com/secweekly

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Through the Roof - SCW #1

Security and Compliance Weekly (audio)

Play Episode Listen Later Nov 7, 2019 72:06

This week, we bring to you our brand new show, Security and Compliance Weekly, hosted by Jeff Man, and Co-Hosted by Scott Lyons, Josh Marpet, and Matt Alderman! In the first segment, Jeff and the hosts talk about PCI and how it affects the state of the union! In the Security and Compliance News, Important security notice about your DoorDash account, How PCI DSS compliance milestones can be a GDPR measuring stick, Companies vastly overestimating their GDPR readiness, only 28% achieving compliance, When Compliance Isn't Enough: A Case for Integrated Risk Management, and much more! Show Notes: https://wiki.securityweekly.com/SCWEpisode1 Visit https://www.securityweekly.com/scw for all the latest episodes! Follow us on Twitter: https://www.twitter.com/securityweekly Like us on Facebook: https://www.facebook.com/secweekly

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Security and Compliance News - SCW #1

Play Episode Listen Later Nov 5, 2019 32:01

Important security notice about your DoorDash account, How PCI DSS compliance milestones can be a GDPR measuring stick, Companies vastly overestimating their GDPR readiness, only 28% achieving compliance - Help Net Security, When Compliance Isn't Enough: A Case for Integrated Risk Management, and much more! Visit https://www.securityweekly.com/scw for all the latest episodes! Show Notes: https://wiki.securityweekly.com/SCWEpisode1

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CRR/IRM Research Program in the UK

CRR Radio

Play Episode Listen Later Sep 4, 2018 16:30

In this episode of CRR Radio we talk with West Midlands FIre Service Chief Officer Phil Loach about the research project being undertaken in the UK to develop evidence-based methods for evaluating the impact of CRR (or as they call it, Integrated Risk Management). Phil Loach is Chief Fire Officer for West Midlands Fire Service, the largest UK Fire & Rescue Service outside of London. Alongside this, CFO Loach is also the Vice Chair for the National Fire Chiefs Council (NFCC) which is made up of Chief Fire Officers from all 50 UK Fire & Rescue Services. Within the NFCC, CFO Loach is Programme Executive for the Community Risk Programme which has been set up to develop a comprehensive, evidence based and accredited risk analysis toolkit that is endorsed by the NFCC to assist UK fire and rescue services in developing their community risk management plans, while also being available to inform the understanding of Government departments around approaches to community risk management. The Programme is currently carrying out a Research Project that will include reaching out across the world to understand the approaches taken internationally when it comes to Community Risk Management. The Community Risk Programme is therefore inviting the International Fire Community to get in touch with the program if they would like to contribute or be involved in the exchange of ideas and sharing of approaches. Fire departments in the United States and other countries outside the UK can do so by contacting Group Commander Martin Ward-White at Martin.Ward-White@wmfs.net.

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Episode 3: Benchmark’s the Spot: The Future of Risk Management

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Play Episode Listen Later May 12, 2018 7:03

In this edition of the SpheraNOW podcast, Carrie Young, Sphera's vice president of solutions consulting, discusses Risk Benchmarking, a recent innovation in Integrated Risk Management. Risk Benchmarking presents a way to move toward a more predictive mitigation model based on leading risk indicators so companies have a better understanding of potential incidents and near-misses so that they can proactively manage their Operational Risk. Though incident rates and events have plateaued or even decreased for some companies and industries, the number of fatalities has increased over the years across the space. Safety is still a large focus for companies and poses significant challenges. Safety professionals are looking for ways to reverse this trend of rising fatality rates through new tools and techniques such as leading indicators and predictive analytics. A standardized approach to incident management and a robust technology suite to underpin it puts a company on the path to success. However, measuring this success relative to the progress made by others in the space is also crucial to making sure a company’s safety processes continue to evolve. This is where risk benchmarking comes in. Sphera's annual benchmarking studies are based on a multi-customer dataset to produce actionable metrics and indicators to help drive excellence in safety by examining and evaluating companies on 80-plus metrics to measure adoption and usage, reporting culture, process discipline, risk sensitivity and learning mindedness.

Episode 1: Wearable Wonders and the Dawn of EHS 4.0

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Play Episode Listen Later May 2, 2018 15:28

In this edition of the SpheraNOW podcast, Andy Hosman, Sphera’s vice president for SpheraCloud, explains why it's only a matter of time before we see more and more companies make the transition to wearables in the workplace to help keep workers safe. We examine some of the challenges facing companies dealing with implementing safety wearables in the workforce, including managing the sheer amount of data generated. We also take a look at the evolution of wearables and discuss how they can improve safety and wellness in the workplace. Augmented and virtual reality, real-time communication and exoskeletons are just some of the emerging technologies that are really changing the game for safety. The future presents a fascinating intersection of data-driven predictive risk management and the integration of the Internet of Things and other devices. As Hosman explains, the secret to success for employing wearables for workplace safety lies in getting wide-scale user adoption and a establishing a strong safety culture. We invite you to learn more about how the dawn of EHS 4.0. is making the workplace a safer place to be.

Episode 0: SpheraNow - We have a lot to talk about!