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, […]
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 […]
Presented by: Saurabh Joshi Shripad, Director for Solutions Engineering, ValGenesis, Inc.Imagine a future where manual paperwork and administrative tasks in commissioning, qualification and validation are reduced to the bare minimum – a future where the transformative power of Digital CQV shapes the pharmaceutical industry towards Pharma 4.0.Join us for an exclusive webinar as we delve into […]
Michael Sieve and James Northup will discuss the changing landscape of Validation, current trends, and industry insight. They will then walk through a day-in-the-life of what Automating your Digital Validation Process looks like, and discuss the benefits of Automated Digital Validation.• Understand the stages of a Validation System• Learn more about Digital Validation and current […]
