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
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
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
For more information and enquiries contact us at
Compliance Trainings
5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada
Customer Support : #416-915-4458
Email : support@compliancetrainings.com
