| |
|
|
|
GlobalCompliancePanel, USA
2010-12-14
Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel has not been designed for regulated environments. However, with a good knowledge of Excel capabilities combined with good procedures and practices on how to validate and use Excel requirements can be met. For example, the FDA is widely using Excel and complies with its own regulations.
Areas Covered in the Session: - Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley.
- Recommendations from the new GAMP®5 and EU Annex 11
- How to design spreadsheets for compliance.
- How to ensure and validate spreadsheet integrity.
- When, what and how much to test?
- Validation of standard/native Excel functions?
- How to apply risk based validation to spreadsheet applications
- Validation of 'ad hoc' spreadsheet applications.
- How to document planning, specifications, installation, testing and changes
- Examples from manufacturing, laboratories and offices
Who Will Benefit: - Everybody developing Excel Worksheets for regulated environments
- QA Managers and personnel
- QC Managers and personnel
- Analysts and Lab Managers
- Validation Groups
- Validation Professionals
- Training Departments
- Documentation Department
- Consultants
|
|
|
|
|
|
|
|
Organized by:
|
|
GlobalCompliancePanel |
|
|
Invited Speakers:
|
|
Dr. Ludwig Huber: - Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
2010-12-09
|
|
|
|
|
|
|
|
Registration:
|
|
Tuesday, December 14, 2010
10:00 AM PDT | 01:00 PM EDT | | | Live live online training only for one participant | | |
| | | | | | Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care) | | |
|
|
|
E-mail:
|
|
webinars@GlobalCompliancePanel.com
|
|
|
|
|
|
|
|
|