Validation and Control of Excel Spreadsheets in FDA Regulated Environments
Price Details
Overview:
Areas Covered in the Session:
Who Will Benefit:
Excel® Applications are widely used in laboratories, offices and manufacturing e.g for data capture, data evaluation and report generation. Regulations such as FDA's GxPs 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 control, validate and use Excel® requirements can be met. Attendees of this webinar will get all details on how requirements can be met.
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
Areas Covered in the Session:
- FDA and other agency's requirements for spreadsheet validation -What do inspectors ask and what documents should be available
- Learning from FDA warning letters related to spreadsheets
- How to design spreadsheets applications for Part 11/GxP/Annex 11 compliance
- Validation during design, development, installation and on-going use
- When, what and how much to test?
- Dealing with standard Excel functions: recommendations from GAMP5
- How to ensure and validate spreadsheet integrity and security for Part 11?
- Learn about specific Excel functions that help to improve quality and compliance
- How Excel spreadsheet applications are used in FDA laboratories
- FDA recommendations for validation of 'single use' spreadsheet applications
- How to document planning, specifications, installation, testing and changes
- Examples from manufacturing, laboratories and offices
Who Will Benefit:
- Pharmaceutical and Medical device Industry
- API Manufacturers
- Contract Laboratories
- Developers and users of spreadsheet Applications
- Validation specialists
- QA/QC managers and Personnel
- Members of the Quality Unit
- Production and Lab Managers
- Regulatory Affairs
- Training Departments
- Documentation Departments
- Consultants
Speaker Profile
Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber's website www.ludwig-huber.com