Presented By: Steve Thompson, Senior Director Product Marketing, ValGenesis• Recent technology advancements that are promising and problematic?• Learning from our past mistakes – How catastrophes became the catalyst for regulatory action• Assessing our current risk management process(es)• Establishing governance for advanced technologies• Knowing who’s ultimately responsible, and how to protect yourself and your companyTakeaway Tools• […]
Presenter:Kim Huynh-Ba, M.S., FAAPS, Managing Director, Pharmalytik LLC; Adjunct Faculty, RAQA Program, Temple UniversityOverview:– Review current regulatory expectations for Data Integrity– Spot common lab data issues and how to avoid them– Strengthen documentation and record keeping practices– Improve system controls and data security measures– Promote a culture of accountability and data ownership
Kim Huynh-Ba, Managing Director, Pharmalytik, LLCIntroductionEfficiency in laboratory operations is essential for maintaining accuracy, reducing turnaround time, and ensuring compliance with regulatory requirements. As technology advances, laboratories can leverage automation, artificial intelligence (AI) and machine learning (ML), cloud-based Laboratory Information Management Systems (LIMS), and real-time analytics to streamline workflows, optimize processes, and improve product quality. […]
Gaurav Walia, Vice President of CSV/CSA/DI & Digital Governance, Head of Chicago PQE Office & Sr. Associate Partner, PQE GroupDemonstration of Risk Assessments Concepts Demonstration of Risk Assessments Tools and Strategies Pivoting Away from Traditional Risk Assessments and Encompassing Critical Thinking Pivoting from CSV to CSA with Critical Thinking/Risk Assessment in Mind Real World Highlights […]
Moderators:Stefan Münch, VP Validation & Qualification, Körber Pharma Consulting | Member of GAMP D-A-CH Steering Committee, ISPE™Donncadh Nagle, CQV Consultant, Jacobs Engineering | Lecturer, TU DublinGuest:Martin Heitmann Senior Manager, d-fine | Secretary of GAMP® Global Special Interest Group Software Automation & Artificial Intelligence, ISPE™The integration of Artificial Intelligence (AI) into GxP-regulated environments is accelerating, prompting regulators to establish clear frameworks and expectations for regulated organizations. EMA’s […]
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