FDA raising quality technology expectations July 16, 2020 Former regulator shares insights from FDA perspective on quality management and fostering a culture of quality Sparta welcomed Cynthia Schnedar, Executive Vice President of Regulatory Compliance at Greenleaf Health, for a spirited conversation about regulation and fostering a culture of quality as part of its Virtual Sparta Connection event in June 2020. Schnedar, formerly of US FDA and US Department of Justice, shared her experience as a regulator, as relates to quality leaders today and in the future. From her unique perspective, she is seeing how quality plays out not just with the companies interacting with FDA, but also quality management within government itself. According to Schnedar, FDA has come to expect minimum technology support for quality systems. But beyond that, FDA recognizes the role of advanced technology needed to achieve improved quality. Those technology advances can include real-time data connections on the shop floor to QMS, leveraging AI/ML to provide insights and faster decisions. Schnedar acknowledged that the life science industries have a long journey ahead, to achieve widespread proactive quality in manufacturing, but that FDA is encouraging it for its undeniable benefits for increased capacity, supply quality and more. In speaking to creating a culture of quality within an organization, Schnedar stressed the importance of communication in driving home company values and how to live those values in quality management. Leaders shouldn’t be shy to repeat themselves on these points. Quality goes beyond manufacturing and supply site compliance, she said, and she described the importance. “You need to have that culture where there’s a reward for bringing problems forward, and people understand that’s the right thing to do. Whistleblowers need to be recognized as bringing value to the company. Otherwise, no one is going to be brave enough to bring a problem forward, instead they’ll be afraid that they’ll be blamed.” Schnedar asks quality managers to make that culture shift a personal priority, and to listen. “Walk the talk and respond. Model behavior.” Watch on-demand Share via: Twitter LinkedIn Facebook Email
EVENT 9th GCC Regulatory Affairs Pharma Summit (and Quality Conference) 2024 GCC Regulatory Affairs Pharma Summit is an annual event that provides platform for pharmaceutical regulatory experts and industry professionals in the GCC region to share insights and discuss about the latest updates in the pharmaceutical regulations. We are Gold Sponsors of the 9th GCC Regulatory Affairs Pharma Summit 2024. Learn more
EVENT Honeywell Life Sciences Innovation Days Honeywell invites you to join us for one of our Life Sciences Innovation Days, a series offered throughout the globe in 2024. We will present a variety of process innovations to support the digital transformation of life sciences manufacturing. Themes will include orchestrating systems and data, preventing and containing cyber incidents, quality control and management, modular automation, and the Honeywell life sciences roadmap. Discussion will address streamlining manufacturing, creating batch records, and fulfilling regulatory reporting requirements. Learn more
EVENT Pharma Manufacturing World Summit Join us at Pharma Manufacturing World Summit on May 14, 2024 where Honeywell's Zillery Fortner will be co-presenting on "The Value of a Unified Life Sciences Solution in Pharma 4.0." Learn more
EVENT TUG Europe Join industry peers at one of these FREE events for TrackWise and TrackWise Digital customers, with two dates and locations to choose from. Enjoy a networking at our pre-event receptions, as we celebrate 30 years of TrackWise! Take advantage of a FREE TrackWise Digital pre-event training workshop. Learn more
EVENT RQA 2024: International QA Conference With diverse industry representation including regulatory authorities like the MHRA, it’s a hotspot for those in GCP, GLP, GMP, pharmacovigilance, and more. The conference has evolved to cover a wider scope, offering unparalleled networking opportunities across three dynamic days for delegates, sponsors, and exhibitors to engage on pivotal industry topics. Register to attend this insightful event where you can hear our Industry Business Development Director, Fabrizio Mangilio deliver one of this year's RQA 2024 keynote sessions. We are Platinum Sponsors of the RQA 2024: International QA Conference Learn more
WEBINAR AI-Driven Innovation: Redefining Quality Management in Life Sciences Take a deep dive into the confluence of AI and life sciences, exploring how artificial intelligence is poised to revolutionize the realm of quality management in the sector. Learn more
EBOOK 5 Things to Know About EUDAMED EUDAMED (European database for medical devices) is a centralized database that aims to enhance the transparency and traceability of medical devices in the EU. Learn more
WEBINAR EUDAMED 2024 and Beyond: Preparing for the Future of Medical Device Oversight Watch our on-demand webinar and gain valuable insights into the transformative impact of EUDAMED on the Medical Device industry. Learn more
WHITE PAPER Future-Proofing a Pharma Manufacturing Legacy through Digital Quality Transformation As industries adopt technological advances and rapidly move into the fourth industrial revolution, it is essential to assess the impact of these isolated data pockets on the workforce, customers and the safety of patients. Learn more
WEBINAR Transforming Quality Operations in the Digital Age Learn how Orion is using TrackWise Digital® to transform quality operations and enhance traceability among suppliers to continuously improve quality and patient safety. Learn more
ON-DEMAND Quality Risk Management for the Pharmaceutical Industry An Introduction to TrackWise Digital® Quality Risk Management (QRM) for the Pharmaceutical Industry. Learn more
CASE STUDY Simplicity at the Forefront: Meitheal Pharmaceuticals Case Study Meitheal Pharmaceuticals Transforms Document and Training Management with TrackWise Digital® Learn more
EVENT Building a Winning Life Science Eco-system – Leveraging the Quality Link between Platform, Processes and Patients Watch this unique webinar to discover how Life Science organizations can a combine a best-in-class platform with freedom of solution choice to improve product quality, productivity, and supply chain continuity. Learn more
CASE STUDY Empowering Innovation: Revelle Aesthetics Transforms Document Management and Training with TrackWise Digital Revelle Aesthetics selected TrackWise Digital to manage its key quality management processes—document management and training management. Learn more