ComplianceOnline

Register

Toll Free: +1-888-717-2436


customer care
Fax: +1-650-963-2556
Email: editor@complianceonline.com
Read Frequently Asked Questions

21 CFR (11) Compliance For Excel Spreadsheets: 2013 & Beyond

Buy Now Section

This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Partet 11 validation.

Speaker
Instructor: Angela Bazigos
Product ID: 702450
Training Level: Basic to Intermediate

Why Should You Attend:

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.

This 2-hr training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on Part 11 validation. We will discuss the common compliance problems with spreadsheets and how you can avoid them. Attendees will also learn about documentation for Part 11 compliance and future trends in compliance for Excel spreadsheets.

Areas Covered in the Seminar:

Who Will Benefit:

Instructor Profile:

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley and has almost 30 years experience in lifescience. She has received a patent for speeding up software compliance and has applied for patents aimed at speeding up software compliance and FDA software audits. She has co-authored “Computerized Systems in Clinical Research” with the FDA, DIA and Academia and teaches classes in project management, computer systems validation, quality assurance and IT. She is the Vice President of the Pacific Regional Chapter of Society of Quality Assurance and writes articles for the SQA journal. She is also a member of DIA, RAPS and CVIC. She was recently inducted into Stanford’s Who’s Who for contributions to the LifeSciences industry.

Bookmark and Share
Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
For substitution, please email editor@complianceonline.com or call +1-650-620-3937.

Auditing and Administrating Human Resource Policies and Practices - 80024SEM
FDA's GMP Expectations for Phase - 80039SEM

This training hasn't been reviewed yet.

Review this training

Training Options Training Duration = 120 Min
$349.00 Access Recorded Version Only
One Person - Unlimited viewing for 6 Months
(For multiple licenses contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
$599.00 Get Training CD Only
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days