Training course “Validation and Use of Excel® Spreadsheets in Regulated Environments” has been pre-accepted by RAPS as eligible for up to one.twenty five credits towards a participant’s RAC recertification on full completion.
Overview: Excel® Applications are extensively utilized in laboratories, places of work and manufacturing e.g., for knowledge seize, data manipulation and report era. debt payoff tracker excel of as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Portion eleven call for customers of software program and computer techniques to demonstrate and document info precision, integrity and confidentiality.
Out-of-the box Excel® has not been designed for controlled environments. Even so, with a great expertise of Excel® capabilities blended with great techniques and techniques on how to validate and use Excel® needs can be met. For illustration, the Food and drug administration is widely using Excel® and complies with its possess restrictions.
For effortless implementation, attendees will acquire:
Person Manual with Excel features that support to comply with Fda requirements
SOP: Validation of spreadsheet apps
SOP: Growth and use of spreadsheets in regulated environments
Gap analysis/checklist for Macros and Spreadsheet programs
Examples for validation paperwork from arranging to reporting
Areas Protected in the Session:
Regulatory needs for spreadsheets Food and drug administration Portion 11, GxP, HIPAA, Sarbanes-Oxley.
Suggestions from the new GAMP®5 and EU Annex eleven
How to style spreadsheets for compliance.
How to ensure and validate spreadsheet integrity.
When, what and how a lot to examination?
Validation of regular/indigenous Excel functions?
How to apply risk based validation to spreadsheet apps
Validation of ‘ad hoc’ spreadsheet apps.
How to document preparing, requirements, installation, screening and changes
Examples from manufacturing, laboratories and offices
Who Will Gain:
Everybody building and making use of Excel Worksheets for regulated environments
QA supervisors and staff
QC administrators and personnel
IT administrators and personnel
Analysts and lab managers
Validation groups
Validation pros
Instruction departments
Documentation department
Consultants
Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global Food and drug administration compliance at Agilent Technologies. He is the editor of Labcompliance, the world-wide on-line useful resource for validation and compliance issues for laboratories. He is the writer of the books “Validation and Qualification in Analytical Laboratories, and “Validation of Computerized Analytical and Networked Systems”, Informa Health care.
Webinar By GlobalCompliancePanel
Value Listing:
Stay : $245.00
Company reside : $495.00
Recorded : $295.00
Telephone: 800-447-9407
Fax: 302-288-6884
GlobalCompliancePanel offers a wide range of channels for broadcasting and exchange of details through net based mostly education, web alerts & dialogue community forums.
There are a number of causes why, but largely it is because we feel that it would consider as well significantly time out of our day to get organized.
It is indeed correct that placing up methods to manage your company does involve an investment of time, but this investment will spend off afterwards on. As soon as you have established up your organizational methods it does not consider any time at all to hold them likely, and to report the data into them. These quite exact same programs will make your daily life easier not only to track down items but also to create stories and schedules which will be required at the yr finishes.
As soon as you manage your business you will encounter the extra benefit of effectively currently being which will come from getting in handle of your enterprise. By this I imply the emotion of effectively becoming skilled when you know the place to uncover almost everything you need each and every working day for your enterprise – the experience of performance which will come from having your finger on the pulse and becoming ready to juggle all people enterprise balls at when! You can do this if you manage your business.