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The Center for Professional Advancement, 90 Minute Accredited Online Training
February 19, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
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 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.
• SAS Statistical Programmers
• Quality Assurance Specialists
• SAS Statistical Managers
• Medical Writers
• Statisticians
• Regulatory Affairs Associates
• Clinical Data Managers
• Directors of Statistical Programming
• CRO's
• Health Care Professionals
• Research University Professionals
Description
This intense 90-minute accredited online course focuses on isolating and cleaning data issues to assure that correct, consistent and reliable analysis data sets are reproducible. Discussions will focus on proven techniques to address real-world issues. Get your SAS technical and validation questions answered and learn efficient tips for accepting and locking the clinical study data base in a timely manner. Selected edit check macros and acceptance testing guide are included in the course.
Module 1: Analysis of Clinical Data Issues:
• Identifying and quantifying the impact of bad clinical data
• Establishing protocol criteria for clinical data acceptance
testing
• Checking for data compliance at all three levels: general,
CDISC domain, and study protocol specific
Module 2: Effective Methods and SAS Macros to Identify Data Issues:
• Developing and testing edit check macros
• Applying standard edit check macro parameters
Module 3: Communicating and Monitoring Improvements in Clinical Data Issues:
• Timely and effective communication of results with Clinical
Data Management
• Managing metrics on clinical data acceptance testing for
quicker data base lock
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Sunil Gupta, Associate Director, Statistical Programming, Quintiles Inc., International SAS Expert, Speaker, Trainer and Author
Sunil Gupta has been an Independent Consultant since July 1994. He became a SAS Institute Quality Partner the following year. In 2000, he became a SAS Certified Professional V6 and in 2003 he passed the SAS Base Programmer Certification exam. During his 14 years experience in the Biomedical, Pharmaceutical, Biotech and Sales & Marketing Industries, Mr. Gupta has been in management and project lead positions. He understands how business functions and how to work together as a team member to achieve results.
Mr. Gupta has developed and taught many topics related to SAS skills and has done numerous presentations and workshops at SUGI, Regional and Local SAS User Groups meetings. Most recently, Sunil was honored to be one of the top 100 notable people in the Medical Device Industry for 2008. In 2006, he released his third SAS book titled “Data Management and Reporting Made Easy with SAS Learning Edition 2.0”.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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salbers@cfpa.com
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