CfPA - The Center for Professional Advancement, New Brunswick, NJ
February 8-9, 2010
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
• CROs
• 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.
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