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CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
May 4, 2011 at 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 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
• SAS Statistical Managers
• Medical Writers
• Statisticians
• Regulatory Affairs Associates
• Clinical Data Managers
• Directors, Statistical Programming
• CRO Professionals
• Health Care Professionals
• Research University Specialists Description
This intense 90-minute accredited online training course focuses on applying comprehensive and concise checklists for SOPs and computer validation as well as project management completion and six-sigma techniques for reducing exposure risks. Discussions will focus on proven techniques to address real-world issues with references for in-depth details. This training will include opportunities for learning assessment.
Module 1: Categories of Submission Issues
• Review of Learning Objectives
• Top Ten Categories: Overall, SAS, SOPs, Training,
Specifications, Data, Development, Validation,
Audit, and Tools
• FDA Computer Systems and Industry Standards: EDC,
Janus, CDISC, HL7, and BRIDG standards and
integration
Module 2: Project Management, Analytics and Key Performance Indicators (KPIs)
• Practical Project Management and Checklists: Training,
Communication, Corrective and Preventative Action
Progress
• Effective KPI’s and Metrics: Study Enrollment, CDM (Data
Issues), Statistical Programming (TLGs), and Site Audits
Module 3: Six-Sigma Techniques and Risk- Based Planning
• Phases of Six-Sigma to improve Data and Specifications
• Better Planning: Risk Matrix, Outsourcing, Data
Management, Analysis, Reporting, and Submission
Question and Answer Session
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Organized by:
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CfPA - The Center for Professional Advancement |
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Invited Speakers:
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Sunil Gupta, Senior Consultant, Gupta Programming, 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. Additionally he has done numerous presentations and workshops at SUGI, Regional and Local SAS User Groups meetings. He has authored and co-authored on this topic. 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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sberg@cfpa.com
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