|Time: 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend:
This course is intended for anyone directly or indirectly responsible for the creation, content or validation of summary data sets, tables, and data lists 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 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission 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
• Quality Assurance Specialists
• IT Professional Support
• SAS Statistical Managers
• Medical Writers
• Regulatory Affairs Associates
• Clinical Data Managers
• Directors, Statistical Programming
• CRO Professionals
• Health Care Professionals
• Research University Specialists
This course will be available On Demand: November 30, 2012
This intense 90-minute accredited online training course focuses on all of the key resources and tips required by SAS Statistical Programmers in the pharmaceutical industry. Project management using SAS Enterprise Guide, as well as analysis, reporting and validation of clinical data such as lab data are reviewed. CDISC and 21CFR Part 11 regulatory requirements are also emphasized.
Students will be able to download and apply relevant SAS examples and utilities. In addition, SAS Statistical Programmers can access useful tips on each of the five analytical SAS procedures e-guides as well as debugging tips. Both managers and technical professionals will benefit from this course. To better manage access to SAS Savvy online resources, students will be able to download twenty SAS Savvy mind maps.