Webinar On 21 CFR 11 Compliance for Excel Spreadsheets
October 21, 2014 - Mississauga ON CACompliance Trainings
uttam@compliancetrainings.com
Phone:4169154458
In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings. Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment. Areas Covered in the Session : Requirements for Excel Spreadsheets FDA Part 11 Validation Guidance Compliance Problems with Spreadsheets Design Specifications for 21 CFR 11 compliance Documentation for Part 11 Future Trends in 21 CFR 11 compliance for Excel Spreadsheets Who Will Benefit: Quality Managers Quality Engineers Small business owners GxP Consultants Quality VPs IT VPs Price Tags: Live Single Live : For One Participant $ 249 Corporate Live : For Max. 10 Participants $ 899 Recording Single REC : For One Participant - Unlimited Access for 6 Months $ 299