The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: December 5, 2013 from 10am to 10:30am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Event Type: fda, validation
Organized By: Referral
Latest Activity: Nov 18, 2013
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 webinar will demonstrate how requirements will be met.
For easy implementation, Attendees will receive:
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 seminar:
Who will benefit:
Dr. Ludwig Huber,Ph.D., is Director of Labcompliance and editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. Dr. Huber 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 200 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars and presentations for the US FDA, ISPE, PDA, USP, PIC/S and several national health agencies. For more information, visit Dr. Huber’s website: www.ludwig-huber.com.