Residual Moisture Testing of Lyophilized Products - Webinar By GlobalCompliancePanel 2012

Key Topics

• FDA inspection/enforcement practices: examples for Warning Letters/483s
• Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley
• The GAMP/ISPE Good Practices Guides and the IVT NIQ Standard
• The FDA Industry Guide: Cybersecurity for Networks
• Compliance concepts for infrastructure vs. networked systems
• Principles and advantages of network infrastructure qualification
• Configuration management and change control: the most important steps
• Approaches and examples for risk assessment
• What and how much to test with the risk based cost/benefits in mind
• Qualification of PC clients, servers, data centers
• Dealing with existing/legacy infrastructure
• Handling security patches
• Dealing with infrastructure for `CLOUD COMPUTING`
• Considerations for network retirement
• Documentation requirements
• How to maintain the validate state during on-going use
• Going through a life inspection

Who should Attend

Lab Supervisors and Managers, Analysts, Analysts, QA managers and personnel, Teachers and Consultants.