Podcasts about pqri

Karen Quatromoni, Director of Public Relations at OMG, introduces the podcast series and its focus on the Digital Twin Consortium (DTC). Bill Hoffman, OMG CEO and Chairman, interviews Doug Kiehl, Senior Director at Eli Lilly and co-chair of the DTC's new pharma and regulatory Working Group. Doug discusses his 30-year tenure at Eli Lilly, the formation of the Disruptive/Transformative Technologies team, and the drivers for digital twin technology in pharma, including industry trajectory and regulatory expectations. He highlights the importance of cross-industry collaboration and the potential of digital twins in manufacturing, compliance, and process validation, emphasizing their role in expediting product development and improving patient outcomes. Action Items [ ] Attract other pharmaceutical companies to join the Digital Twin Consortium and contribute to working group efforts. [ ] Develop a charter and focus areas for the Pharma and Regulatory Working Group. [ ] Explore applications of digital twins across the pharmaceutical product development and manufacturing lifecycle. Outline Introduction and Welcome Karen Quatromoni introduces herself as the Director of Public Relations for Object Management Group (OMG) and welcomes Bill Hoffman and Doug Kiehl to the OMG podcast series. Karen highlights OMG's role in driving industry standards and building tech communities, and introduces the focus on the Digital Twin Consortium (DTC). Bill Hoffman introduces Doug Kiehl, Senior Director at Eli Lilly and Company's Disruptive/Transformative Team and Digital Twin Center of Excellence, and chair of the DTC's new pharma and regulatory Working Group. Doug Kiehl thanks Karen and Bill for the introduction and expresses his gratitude for organizing the podcast. Doug Kiehl's Background and Role at Eli Lilly Doug Kiehl shares his 30-year tenure at Eli Lilly, his experience in product development, and his roles in various capacities with government and private industry. He mentions his background as a mass spectrometrist and analytical chemist, and his role in forming the Disruptive/Transformative Technologies team at Eli Lilly. Doug explains the two main drivers for forming the Disruptive/Transformative Technologies team: industry trajectory and regulatory expectations. He highlights his involvement with the Product Quality Research Institute (PQRI) and his role as the chair for the PQRI steering committee, which includes FDA and Health Canada stakeholders. Formation of the Disruptive/Transformative Technologies Team Doug discusses the formation of the Disruptive/Transformative Technologies team one year ago, driven by the need for digital transformation in the pharmaceutical industry. He emphasizes the importance of cross-collaborative partnerships, mentioning his liaison with various industries, including defense, Air Force Research Labs, Army Research Labs, and NASA. Doug expresses his satisfaction with the Digital Twin Consortium for enabling access to these partnerships and advancing their goals. Bill Hoffman acknowledges Doug's impressive background and the strong connection between different industries applying digital twin technology. Charter and Importance of Digital Twins in Pharma Doug outlines the charter of the new working group, focusing on attracting other pharmaceutical companies to join the Digital Twin Consortium. He highlights the broad application of digital twin technology throughout the pharmaceutical product development and manufacturing life cycle, including supply chain and post-launch life cycle management. Doug mentions the importance of modeling clinical trials to minimize...

On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss: Supplier Management for Combination Products Drug & Device Analytical Testing Considerations for Biologics Connected/Digital Health Changing Regulatory Landscape for Combination Products Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press. Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development.  Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries. She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees.  Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request. She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums. 

On this episode, I was joined by Susan Neadle, Principal Consultant and President of Combination Products Consulting Services LLC. Susan and I discuss: Part 1 of The Combination Products Handbook: A Practical Guide to Combination Products and Other Combined Use Systems: Foundation Subhi's questions on each chapter What she learned from authoring and coordinating of the book Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience.  She has just published “The Combination Products Handbook: A Practical Guide” through Taylor & Francis Group/Routledge/CRC Press.   Her leadership, innovation, and best practices have been recognized with several awards, including the 2022 ISPE Joseph X. Philips Professional Achievement Award for extraordinary contributions to the industry; 2021 TOPRA Award Finalist for Regulatory Affairs Excellence; and the Johnson Medal, Johnson & Johnson's highest honor for excellence in Research & Development.  Susan retired from a distinguished and impactful career at Johnson & Johnson and is now Principal Consultant at Combination Products Consulting Services LLC, providing international quality, regulatory affairs, and design excellence services, to the biopharma, biotech, and medical device industries.    She continues to fulfill her passion in this space as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International and AAMI standards committees.  Susan teaches curricula in Combination Products through UMBC, AAMI, and DIA, as well as customized training upon request.  She is also active in multiple industry working groups including CPC, AFDO/RAPS, DIA, TOPRA and PQRI, and enjoys speaking at a variety of industry forums.   Susan can be reached at sneadle@combinationprod.com.

MACRA (formerly PQRS...formerly PQRI...) is here to stay. Many anesthesia providers & anesthesia practices have spent time either avoiding it or pushing back against it, but the CMS quality program doesn't appear to be going anywhere any time soon.Sure, non-compliance may mean reimbursement penalties. But have you considered what a proactive approach toward MACRA might mean for your practice?In this episode, Dr. Zavaleta will discuss a more proactive way of thinking about and dealing with MACRA for anesthesia practices looking to turn something painful into something beneficial.

Nandini Kashyap interviews Dr. William P. Beierschmitt, Ph.D., DABT, FATS, Regulatory Strategy Lead at Pfizer on December 20, 2013. Dr. Beierschmitt will be speaking during the 2nd Annual Extractables and Leachable conference taking place January 16-17 as part of PepTalk, January 13-17 in Palm Springs, CA. Topics include early adoption of toxicological risk assessment, risk assessment strategy, patient safety, safety issues related to extractables and leachables, role of toxicologist, plastic single use bioreactors, single use systems, risk based assessment, extractable testing, flexible manufacturing, process and product development, BPOG, USP, PQRI, standardized E&L testing, predication of leachable, toxicity and safety.

Nandini Kashyap interviews Dr. Yasser Nashed-Samuel, Principal Scientist, Amgen on December 6, 2013. Dr. Yasser Nashed-Samuel will be speaking during the 2nd Annual Extractables and Leachable conference taking place Jan16-17 as part of PepTalk, January 13-17 in Palm Springs, CA. Topics include a case study on E&L from single use bioreactors, E&L impact on cell culture performance, plastic single use bioreactors, single use systems, risk based assessment, extractable testing, flexible manufacturing, process and product development, , BPOG, USP, PQRI, standardized E&L testing, predication of leachable, toxicity and safety.

MPT Podcast 35 - 101 Ideas to Increase Revenue & Decrease Costs Part 2, with guest Mary Pat Whaley of ManageMyPractice.com. Ms. Whaley shares more of her many suggestions for increasing profit for your medical practice. This Issue (7:30): Some useful tips on obtaining Meaningful Use incentives Why you shouldn't purchase an EMR just for the incentives How do PQRI and E-Prescribing come into play? Are there any other financial incentives or grants you can qualify for? Click the play button to hear the podcast   [smart_track_player url="http://mptaudio.s3.amazonaws.com/$emed$podcast/MPT_podcast_35.mp3" title="MPT Podcast 35-101 Ideas to Increase Revenue & Decrease Costs Part 2" ] Right-click to download

  EMR Update 6 - eRx and PQRI: Are Your Leaving Money on the Table? This Issue: How can your practice qualify for 'Stimulus Bill' financial incentives? ePrescribing(eRx) & PQRI - what bonuses can you expect for each? How do you make a claim? Find out about PQRI Toolset, a tool that can help you claim bonus payments (Note: MPT has a financial interest in Protodrone LLC, creator of PQRI Toolset)   [smart_track_player url="http://mptaudio.s3.amazonaws.com/$emed$podcast/MPT_podcast_6.mp3" title="MPT Podcast 6-ePrescribing, PQRI, and ARRA Incentives" ]

According to Dr. Bruce Bagley, the cornerstone of PQRI is quality improvement, and any bonus payments physicians receive for reporting efforts are just that --- by-products of the process. Dr. Bagley, medical director of quality improvement for the American Academy of Family Physicians, also shares his views on the value of patient registries and other healthcare IT for PQRI, and advises physicians who may be frustrated by their PQRI experiences. Dr. Bagley, along with Betsy Nicoletti, consultant, Medical Practice Consulting, LLC, described how PQRI can provide physician practices with a great start on registries and measurement and reporting and provided practical hands-on PQRI coding and auditing strategies during a March 18, 2009 webinar, Physician Quality Reporting Initiative in 2009: How To Avoid Submission Errors and Improve Reimbursement.

Guest: Mary Igo, MBA, RN Host: Mark DeLegge, MD The Physician Quality Reporting Initiative (PQRI) is a CMS-based program designed to help medical professionals measure performance outcomes in their practice. How does the PQRI define quality, and how can it provide more concrete measurements of quality? What do GI practices need to know when becoming involved in the PQRI? Mary Igo, MBA, CEO of Minnesota Gastroenterology, a GI practice based in St. Paul, and an expert in medical group management, assesses the pros and cons of implementing the PQRI system with host Dr. Mark DeLegge.

Guest: Mary Igo, MBA, RN Host: Mark DeLegge, MD The Physician Quality Reporting Initiative (PQRI) is a CMS-based program designed to help medical professionals measure performance outcomes in their practice. How does the PQRI define quality, and how can it provide more concrete measurements of quality? What do GI practices need to know when becoming involved in the PQRI? Mary Igo, MBA, CEO of Minnesota Gastroenterology, a GI practice based in St. Paul, and an expert in medical group management, assesses the pros and cons of implementing the PQRI system with host Dr. Mark DeLegge.

Lorraine Larrance, consulting senior manager with Pershing Yoakley and Associates, and Sue Kincer, consultant and certified professional coder with Pershing Yoakley and Associates, discussed the 2008 PQRI measures, the challenges physicians will face and the quality improvements that could result for physician practices. Kincer and Larrance, along with Dr. Bruce Bagley, AAFP medical director of quality improvement, delved into the requirements for PQRI for 2008 and drew upon their past experiences with physician quality reporting to recommend how to succeed in the 2008 program during a January 22, 2008 webinar, Physician Quality Reporting in 2008: What Every Physician Practice Should Know.

Although CMS does not currently require physicians in the Physician Quality Reporting Initiative to have electronic health records, nearly 75 percent of American Academy of Family Physicians members are already using EHRs, estimates Dr. Bruce Bagley, AAFP medical director of quality improvement. CMS' inclusion of two structural measures for 2008, one for EHRs and the other for e-prescribing, are more likely CMS' attempt to provide measures that both family physicians and specialists can report on, says Dr. Bagley, as well as support President Bush's mandate that EHRs move forward. Dr. Bagley advises PQRI participants to proactively examine their own reported data to chart a performance improvement plan rather than wait until mid-2008 for feedback from CMS. Bagley, along with Sue Kincer, consultant and certified professional coder with Pershing Yoakley and Associates and Lorraine Larrance, consulting senior manager with Pershing Yoakley and Associates, delved into the requirements for PQRI for 2008 and drew upon their past experiences with physician quality reporting to recommend how to succeed in the 2008 program during a January 22, 2008 webinar, Physician Quality Reporting in 2008: What Every Physician Practice Should Know.