Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Instructor:
Dr. Ludwig Huber
Product ID: 701242
- Duration: 75 Min
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.
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
- Consultants
Dr. Ludwig Huber
Director and Chief Editor, Labcompliance
Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. Dr. Huber 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.
More Training By Experts
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- 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
- Effective Training for FDA Compliance: What to train - How much to Train - How to Document Effectiveness
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
