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Validity : 22nd Apr'25 to 02nd May'25
Using Excel for FDA Compliance
- FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
- We will discuss spreadsheet related examples of warning letters and give recommendations on how to avoid then.
- Design, develop and validate spreadsheets for Part 11/GxP/Annex 11 compliance.
- When, what and how much to test for spreadsheet validation?
- How to ensure and validate spreadsheet integrity and security for GxP and Part 11?
- Validation of 'single use' spreadsheet applications.
- How FDA is using spreadsheets.
- How to document planning, specifications, installation, testing and changes of Excel spreadsheets.
- Examples from manufacturing, laboratories and offices.
Overview of the webinar
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,with practices on how to control,validate and use Excel® and with “add on”software the requirements can be met.
Who should attend?
- Software engineer
- IT administrator
- QA/QC manager
- Laboratory chemist and supervisor
Why should you attend?
Attendees will understand how Excel can be used for FDA and other national and international regulations despite of limited Part 11 functionality. Correct understanding of the regulatory requirements combined with a good understanding of FDA/Part 11 related functionalities will ensure efficient design and development and use of spreadsheet applications while reducing or eliminating FDA warning letters and 483 form inspectional observations.
Faculty - Dr.Ludwig Huber
Dr. Ludwig Huber, Ph.D., is the chief advisor and editor of www.labcompliance.com 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, and of the 70-page primer: Validation of Analytical Methods".
He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.
Dr. Huber has been awarded as
• The Presenter of the year at IVT conferences, selected by thousands of attendee as #1 out of 175 presenters
• The Winner of the "First International GLP Award" from Indian Drug Manufacturer Association for Publications and Presentations in the Area of GLP and GMP
• Winner of the Wallhaeusser award, sponsored by the European Compliance Academy for publications in the area of 'Quality and Safety of Drugs'