Published By VTI Life Sciences Introduction The pharmaceutical industry is undergoing a significant transformation driven by digitization and artificial intelligence (AI). As regulatory expectations from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to emphasize data integrity, traceability, and compliance, Good Manufacturing Practice (GMP) systems must […]
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• […]
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 […]
Presented by: Moderator: Chinmoy Roy, Senior Industry Consultant, ValGenesisPanelists: Rosalind Beasley, Chief Executive Officer, Main and Mission Inc.Roy Devine, Global Process Owner Computer System Validation, BDDaniel Walter, Policy Analyst, CDRH, U.S. FDA
Moderator: Harsha Chulki, Head of Global IT Quality, Compliance & CSV, ICU Medical Inc.Panelists:Sachin Bhandari, Head of CSV and Qualification Standards, Boehringer Ingelheim International GmbHLoganathan Kumarasamy, Head – Scientific Informatics & Compliance Services, Zifo Technologies Inc.Rosalind Beasley, Chief Executive Officer, Main and Mission Inc.Discover how artificial intelligence (AI) is transforming the world of Computer System […]
