Fda - Industry Csa Team

CSA Revolution Series: Computer Software Assurance DIRECT FROM THE SOURCE FDA - INDUSTRY CSA TEAM FICSA Team Fresenius CSA Journey Panel Discussion (With team members from FDA & Siemens) "Episode 3” - Live Webinar Series, Thursday August 6th, 2020 PANELISTS Bill D’Innocenzo Marc Koetter Francisco (Cisco) Vicenty Jason Spiegler Sr Director, Strategic Initiatives Life SVP, Digital Integration Global Manufacturing, Sr. Manager, IT FRESENIUS Program Manager, Case for Quality Quality & Supply - FRESENIUS CDRH - FDA Sciences Practice - SIEMENS Khaled Moussally (Host) EVP, Clients & Regulatory Relations – COMPLIANCE GROUP Hosted By FDA - Industry CSA (FICSA) Team Members Bill D’Innocenzo Francisco (Cisco) Vicenty SVP, DIGITAL INTEGRATION GLOBAL MANUFACTURING, QUALITY & SUPPLY PROGRAM MANAGER, CASE FOR QUALITY, CDRH Bill D’Innocenzo, SVP Digital Integration works within the Global Manufacturing, Quality and Cisco Vicenty is currently the Program Manager for the Case for Quality (CfQ) within the Office of Compliance, Center for Devices and Supply group at Fresenius Medical Care. Bill is a life-long process improvement professional with Radiological Health (CDRH), FDA. This effort is part of the CDRH strategic priorities for 2016 and 2017and will improve access and more than 35 years of experience. He leverages the principles, tools and techniques of continual patient outcomes process improvement to help organizations deliver bottom line sustainable results and drive by engaging industry, payers, providers, and patients to increase focus on the quality and performance of medical devices. significant business value. Cisco began at the FDA as a compliance officer in the Cardiac Rhythm and Electrophysiology Branch in the Office of Compliance at He began his career in Research & Development, later moving into Manufacturing Operation roles; CDRH. He then worked as a project manager for the FDA’s Case for Quality initiative. Prior to his current role, Cisco was the Branch developing and refining his skills in the disciplines of industrial, process and test engineering. Chief of the Respiratory, E/N/T, General Hospital, and Ophthalmic Devices Branch in the Division of Manufacturing and Quality, within Process and operational excellence is the cornerstone of Bill’s focus – getting the right people the Office of Compliance. working on the right projects and tasks employing effective processes are critical to an organization’s success. He seeks to achieve the proper balance to leverage the people, process and technology triad. Deploying simple, yet highly effective and efficient processes is always the Jason Spiegler targeted result. SR DIRECTOR, STRATEGIC INITIATIVES LIFE SCIENCES PRACTICE Bill has held various senior and executive level positions in R&D, Quality Assurance and Manufacturing Operations for high-tech and medical device manufacturing. He has established himself as a change agent focused on organizational behaviors and culture that deliver high performance and achieve sustainable, long-term results. Jason has worked in the Life Sciences and Technology industries for 22 years in various Quality, Business Development, and Sales Management roles. Prior to Siemens, Jason worked for Johnson and Johnson, and several medical device start-up companies. In his last start-up, he served as the Head of Quality, responsible for implementing all elements of the Quality System and executing their quality Marc Koetter strategy with all external partners. SR. MANAGER, IT Jason has been with Siemens Digital Industries for 13 years. He is responsible for leading many of their strategic activities between FDA and customers within the Life Sciences practice. Jason is also responsible for the customer experience at several strategic customers. He is especially passionate about partnering to reframe big problems to create more transformative impactful solutions, leveraging both leadership and technology. Marc leads the IT Quality Assurance function at Fresenius Medical Care, which defines all corporate software quality procedures, performs software quality assurance (testing), validation, and infrastructure qualification. Additionally, he is a corporate quality systems auditor for ISO 13485, Khaled Moussally FDA CFR 820, MDSAP and other regulations. He is a multi-disciplined professional with extensive Executive Vice President CLIENTS & REGULATORY RELATIONS experience in quality engineering and quality management. He has been in the life science space since 2003 and has worked both on the manufacturer, vendor, and consulting sides of the business. Since 3 years he leads the quality assurance activities for Fresenius Medical Care´s program to harmonize and implement a standardized SAP system at >40 countries globally. Khaled is a Quality & Compliance executive and a thought leader providing cutting-edge solutions to Life Sciences industry. After Marc is a member of the “FDA – Industry CSA team” contributing to the FDA draft guidance spending over 25+ years with corporate in IT, Manufacturing and Quality, Khaled transitioned into consulting to bring about a “Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software”. paradigm shift in Quality & Compliance by leveraging his experience with regulatory agencies. Khaled is a key participant of the MDIC “Case for Quality Initiatives” and a member of the “FDA – Industry CSA team” contributing to the FDA draft guidance “Computer Software Assurance (CSA) for Manufacturing, Operations, and Quality System Software”. Khaled is on the “ISPE GAMP America Steering Committee” and has co-presented with the FDA in numerous industry conferences on how to reduce CSV cycle times while Hosted By enhancing quality by applying CSA concept. Agenda ❑ Meet the “FDA-Industry CSA Team”(FICSA) Members! ❑ FICSA TEAM Journey ❑ Fresenius CSA Journey & Implementation ❑ Next Steps Objectives ❑ Don’t wait for the FDA Draft Guidance to be released ➢ Start thinking how you want to implement CSA ➢ Pilot Studies Effective ➢ Digitize your current paper CSA processes ❑ Create awareness to accelerate innovation ❑ Inspire action so you can begin to realize value Hosted By FDA - Industry CSA (FICSA) Team Members CSA Revolution Series Game Changer Kick Off Webinar Series Was back on April 23rd, 2020 • Recorded Webinar - CSA Game Changer Webinar with the Cisco Vicenty from FDA Click Here • Webinar Material - Click Here • CG/ CSA White Paper - Hosted By How did the CSA Initiative begin? Hosted By CSV identified as a barrier for the FDA… For your technology investments, what are the barriers for Realizing Value? CSV!!! www.fda.gov Hosted By Cultural Barriers Paralyzing Industry For software not used in product, manufacturers refer to significantly more burdensome guidance (20+ years old), based on Fear of a 483, based on prior FDA Investigations and 3rd Party Consultants. “Too much documentation – lot “We are risk-based… “We validate all Software… of overhead for little value!” everything is high risk!” like product Software!” Summary of Impact “It took 4x longer for CSV “Most deviations are documentation errors, than the actual analysis!” • Manufacturers are reluctant to invest not Software bugs - we trip over ourselves!” • When they invest, the documentation “Data mining? We looked at purchasing an burden is excessive (not commensurate inexpensive BI tool, but CSV cost was too high.” with Risk) impacting “Time to Value” • Cybersecurity (Enterprise) risk increases “The real pain no one discusses, is the CSV burden over the lifecycle of maintaining software.” ➢ Slow to upgrade/ implement patches due to “revalidation” lifecycle burden “What If analysis not practical to maintain” • Impacts all Centers across FDA! Hosted By FDA - Industry CSA Team (FICSA) Company Name Company Name Baxter Healthcare Tina Koepke Johnson and Johnson Reggie George Boston Scientific Damien McPhillips Lantheus Imaging Lou Poirier Boston Scientific Ray Murphy Medtronic Frankie Bill Compliance Group Khaled Moussally Medtronic Michael Branch Edwards Lifesciences Andy Lee Medtronic April Francis FDA Cisco Vicenty NeuroVision Imaging Pepe Davis Fresenius Medical Care Bill D'Innocenzo Ortho-Clinical Diagnostics Des Chesterfield Fresenius Medical Care Marc Koetter Siemens Digital Industries Jason Spiegler Gilead Sciences Ken Shitamoto Siemens Digital Industries Greg Robino Gilead Sciences Senthil Gurumoorthi Roche Thorsten Ruehl Johnson and Johnson Ron Schardong Omnicell Frank Meledandri Sr. Join FICSA LinkedIn Group Contributions also provided by past team members: Stacey Allen, Jason Aurich, Sean Benedik, Laura Clayton, Bill Hargrave, Joe Hens, Scott Moeller, John Murray, Penny Sangkhavichith, Dana Guarnaccia, and Curt Curtis. Hosted By FRESENIUS MEDICAL CARE (FMC) GMQS TRANSFORMATION FROM CSV TO CSA Hosted By FRESENIUS MEDICAL CARE (FMC) INTERNAL CONCERNS TO IMPLEMENT CSA “This is only recognized by the FDA. “This does not comply to existing best How about other regulatory bodies like practices like GAMP5“ e.g. those in the EU?” “We should better be conservative and “We should wait until the FDA guidance follow common best practices to assure is officially released“ compliance“ “No test evidence does not follow FDAs “FDA expects to test the whole requirement „what is not documented is software.” not done“. “Every stakeholder incl. QA need to sign relevant documents“ 8/6/2020 Page 10 Hosted By THREE PILLARS OF TRANSFORMATION FROM CSV TO CSA Test Execution and CSA DOCUMENTATION SIGNATURES Result Documentation ✓ Change document templates ✓ Establish

Load more