Category: Webinar

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Creating an Effective Complaint Handling System

Presented by Kimberly Wallbank, Principal Consultant, Quality Systems Services, LLC Top Reasons to Attend:• Understand the importance of an effective complaint handling system• Define the key aspects of a complaint handling system• Acting on complaints – how to investigate• Understand the importance of tracking and trending complaints• How to process the investigational findings in a […]

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Modernize Continuous Improvement Methodologies for Pharmaceutical Quality Systems

Presented by: Connie Leech, Global Director Quality, Compliance & Regulatory Affairs, CAI Top Reasons to Attend• A smarter approach to Pharmaceutical Quality System• Gain a deeper understanding Continuous Improvement tools and Methodology from a Process, Quality and Compliance Perspective• Digital Transformation in Quality Management Systems• Quality 4.0 and a connected ecosystem• Focus on the impact […]

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Project Management – Understanding Your Sphere of Influence

Presented by: Patrick Hayes, Associate Director Program and Project Management, CAI, Inc. & Erik Adams, Associate Director Program and Project Management, CAI, Inc. Top Reasons to Watch:• Define the Sphere of Influence within Project Management• Understand the Importance of working within your Sphere of Influence• Maximizing the Project Managers Sphere of Influence• Understanding Industry Engagement […]

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CGMP’s – Why Are We Still Getting It Wrong?

Presented by Karen Zimm, Associate Director for Janssen Pharmaceuticals and Renée Phillips, Associate Director of Global Regulatory Affairs at Janssen Research & Development Top Reasons to Attend: • What does FDA continuously cite on 483?• Why does industry make the same mistakes over and over?• Possible systemic reasons• Contributing factors CGMP’s – Why Are We […]

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Compliance Advantages of Moving Towards Paperless Integrated Risk-based CSV

Presented by: Rick Mineo, Director of Strategic Partnerships- Kneat, and Martin Radecki, Sr. Partner and Managing Director- Veqtor Validation experts Rick Mineo and Martin Radecki will go through the different compliance advantages to using paperless validation with integrated risk-based CSV processes. This webinar will cover the tools needed to be successful when taking this approach […]

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