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.
