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Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]
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
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 […]
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 […]
By Jane Weitzel, Quality Control Expert, and USP Council of Experts Member & Chair of the 2020-2025 General Chapters –Measurement and Data QualityFit for intended purpose is a key, central concept for USP <1220> Analytical Procedure Life Cycle, ICH Q2(R2) Validation of Analytical Procedures, and ICH Q14 Analytical Procedure Development. The performance criteria for the […]
