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Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
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 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 validate and use Excel® the requirements can be met. This webinar will demonstrate how requirements will 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
- Examples for validation documents
Note: These complimentary hand-outs will be sent to customers on request. Please email firstname.lastname@example.org for these documents, stating your order number, and they will be emailed to you within 4 working days.
Areas Covered in the Webinar:
- 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/SOX/HIPAA 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 GxP and Part 11?
- 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:
- Pharmaceutical and medical device industry professional
- Contract laboratories
- All developers and users of spreadsheet applications
- Validation specialists
- QA/QC managers and personnel
- Production and lab managers
- Regulatory affairs Professionals
- Training department Personnel
- Documentation department Personnel
Dr. Ludwig Huber, Ph.D., is the director of Labcompliance 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". He has given multiple 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 SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.
ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.
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Dr. Ludwig Huber
Understanding and Implementing USP <1058>: Analytical Instrument Qualification Change Control for Computer Systems - strategies and tools for FDA compliance Master Planning for Computer System Validation Managing Failure Investigations and OOS Situations - Regulatory Requirements and Strategies for Implementation