Webinar On 21 CFR 11 Compliance for Excel Spreadsheets

Description :

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

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1399