Webinar - Events

This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers. Areas Covered in the Webinar: Regulatory Requirements for Quality Agreements Defining the Purpose of Quality Agreements Different Types of Quality Agreements with Service Providers Definition of Roles Between the Manufacturer and Service Providers Regulatory Roles in the Quality Agreement Expectations for Quality Agreements in Regulatory Inspections. Benefits of Quality Agreements from Both a Regulatory and Quality Perspective Enforcement of Quality Agreements Monitoring of Agreements. Wh…

📅 Date: 20 March, 2025  ⏰ Time: 16:00 CET 🔗 Register now with just two clicks Join SOLTI and Flex Databases to discover how SOLTI transformed trial management, overcame challenges, and unlocked the full potential of digitalization. Our expert panel includes:🔹 Marietta Sarkisian - Global Director, Business Development, Flex Databases🔹 Lídice Vidal - Chief Clinical Operations Officer, SOLTI🔹 Francesca Teulé - Clinical Trial Manager, SOLTI🔹 Paula Fornieles - Clinical Research Associate, SOLTI Agenda Recognizing the need for a CTMS: When and why clinical teams realize they need a system, key triggers, and SOLTI’s experience. Transition to Flex Databases: SOLTI’s past experience (confidential), selection process, and key benefits. Implementation and migration: What…

This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates. Learning Objectives: Which data and systems are subject to Part 11 and Annex 11 Computer Software Assurance impact on risk-based Impact of Electronic Systems… Clinical Investigations Q&A Guidance for Industry Oct 2024 Avoid 483 and Warning Letters Requirements for local, SaaS, and cloud hosting Reduce validation resources by using easy to understand fill-in-the-blank validation documents Areas Covered in the Webinar: What 21 CFR Part 11 means t…