Course offering number:0910-405
Course ID:
2234
Best Practices in SAS Statistical Programming for Regulatory Submission
19-20 October 2009
Hoofddorp
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 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’s
• 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.
Past Participants have said…
“The class will help me implement new standards immediately and will aid in creating a programming environment where planning and validation are integral in developing submission tables and listings sufficient for regulatory review and audits. Sunil’s course was a pleasure to take.”
- C.W., Biostatistic Supervisor, Tolmar Inc.
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