Attend this seminar to learn about proven industry practices for network qualification. Configuration management and change control as the most important network qualification steps.
Why Should You Attend:
Federal laws and regulations mandate to put controls and measures on a company network to ensure security and data integrity. Examples are 21 CFR Part 11, Sarbanes-Oxley Act, and HIPAA. With FDA's renewed focus on computer validation and IT systems, industry is looking for advice on how to comply for networks and infrastructure.Areas Covered in the seminar:
- Laws, regulations and guidelines- 21 CFR Part 11, HIPAA, Sarbanes-Oxley.
- The FDA Industry Guide: Cyber security for Networked Medical Devices.
- The GAMP/ISPE Good Practices Guide.
- The IVT proposed NIQ standard.
- Principles of network infrastructure qualification.
- Compliance concepts for infrastructure vs. networked systems.
- Configuration management and change control as the most important network qualification steps.
- Qualification of PC clients, servers, data centers.
- What and how much to test with the risk based cost/benefits in mind: network components, servers, PC clients, applications, initial vs. on-going testing.
- How to ensure highest system uptime with on-line monitoring tools
- Documentation requirements.
- Going through a life inspection.
- Software tools for infrastructure qualification.
Who Will Benefit:
- IT managers and personnel
- Everybody responsible for FDA compliance of computer systems
- Managers from purchasing, documentation and operations
- All users of computer systems used in regulated environments
- QA managers and personnel
- GLP/GMP/GCP auditors
- Consultants
- Teachers
Course Provider
Dr. Ludwig Huber,
