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 To access this post, you […]
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 […]
Presented by: Cody Beaumont, Associate Director, Quality Compliance and Regulatory, CAIAnnex 1 and a Contamination Control Strategy are critical aspects of pharmaceutical manufacturing, focusing on maintaining quality, safety, and compliance as is expected in a regulatory setting. Annex 1 of the European Union’s Good Manufacturing Practice (GMP) serves as a guideline and cornerstone for sterile […]
Presented by: Hector Felix, Senior Validation Engineer at VTI Life SciencesThis webinar will cover the best practices you must implement whether you ship or store temperature-sensitive products. Participants will learn about the regulator context, what has to be done, and how with real concrete examples and case studies.The course details will include:DefinitionTemperature Mapping IntroductionWhy should […]
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