Instructor: Dr. Ludwig Huber This excel validation training/ webinar will demonstrate how to design spreadsheets for part 11/GxP /SOX/HIPAA, document planning, specifications, installation, testing and changes to meet FDA requirements. Why Should You Attend:
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. 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® the requirements can be met. This seminar will demonstrate how requirements will be met.
Hand -Outs:
For easy implementation, Attendees will receive:
* User Manual with Excel functions that help to comply with FDA requirements
* SOP: Validation of spreadsheet applications
* SOP: Development and use of spreadsheets in regulated environments
* Gap analysis/checklist for Macros and Spreadsheet applications
* Examples for validation documents
Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.
Areas Covered in the seminar:
* FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
* How to design spreadsheets for part 11/GxP/SOS/HIPAA compliance.
* Validation during design, development, installation and on-going use.
* When, what and how much to test?
* Dealing standard Excel functions: Recommendations from GAMP® 5.
* How to ensure and validate spreadsheet integrity for GxP and part 11?
* How to apply risk based validation to spreadsheet applications.
* Validation of 'ad hoc' spreadsheet applications.
* How to ensure spreadsheet security and integrity for Part 11 and EU Annex 11.
* How to document planning, specifications, installation, testing and changes.
Who will benefit:
* Pharmaceutical and medical device industry
* All developers and users of spreadsheet applications
* Validation specialists
* QA managers and personnel
* Regulatory affairs
* Production and lab managers
* Training department
* Documentation department
* Consultants
Instructor Profile:
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of www.labcompliance.com , 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. For more information, visit Dr. Huber’s website: www.ludwig-huber.com . more
