Why Should You Attend:
This webinar will focus on applying comprehensive and concise checklists for SOPs and computer validation as well as project management completion and six-sigma techniques for reducing exposure risks. The discussions will focus on proven techniques to address real-world SDTM and ADaM mapping issues relating to FDA submissions.
The session will focus on increasing confidence in FDA submission acceptance testing by thoroughly checking and questioning all details before an FDA audit. Further, to better manage access to SAS Savvy online resources, attendees will be able to download twenty SAS Savvy mind maps and have a free trial SAS Savvy membership.
Areas Covered in the Webinar:
Module 1: Categories of Submission Issues
Module 2: Project Management, Analytics and Key Performance Indicators (KPIs)
Module 3: Six-Sigma Techniques and Risk-Based Planning
Who Will Benefit:
Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course. In addition, this course is ideal for IT groups supporting FDA submissions. Effective and practical solutions to address real-world issues will be provided. This course is recommended for:
Sunil Gupta is an international speaker, best-selling SAS author, and a global corporate trainer. He is the principal SAS/CDISC consultant at Gupta Programming since 1994. Most recently, he taught both of his CDISC online classes with the University of California at San Diego and SAS Institute India. Mr. Gupta will start to teach the new Sharpening Your SAS Skills online class for UCLA Extension in 2016. In 2011, he launched his unique SAS resource blog, SASSavvy.com, for smarter SAS searches. Currently, SAS Savvy’s membership consists mostly of SAS programmers, university students and pharmaceutical corporate accounts.
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 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. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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