Best Practices in SAS Statistical Programming for Regulatory Submission
This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.
This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is intended for anyone directly or indirectly
responsible for the creation, content or validation of summary
tables, data lists and graphs used to support research, drug
or medical device efficacy and safety in a regulatory
submission. Professionals in the pharmaceutical,
biotechnology and medical device industries who want to be
21 CFR Part 11 compliant in relation to the SAS
programming environment will benefit from this unique
course. Effective technical and practical solutions to address
real-world issues will be provided.
This course is recommended for:
• SAS Statistical Programmers
• SAS Statistical Managers
• Director, Statistical Programming
• Statisticians
• Clinical Data Managers
• Quality Assurance Specialists
• Medical Writers
• Regulatory Affairs Associates
• CRO Professionals
• Health Care Professionals
• Research Universities
Description
This intense two-day course focuses on the validation
process to assure that correct, consistent and reliable
summary tables are reproducible. In addition, a variety of
effective methods for producing standard and custom
summary tables will be provided. SAS data sets used in
the course are CDISC ready. Discussions will focus on
proven techniques to address real-world issues. Get your
SAS technical and validation questions answered and learn
efficient tips for producing a quality regulatory submission in
a timely manner. Students will receive a CD containing all
tools and SAS macros reviewed in the course.