ComplianceOnline

Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment

Instructor: Sunil Gupta
Product ID: 704594
  • Duration: 75 Min
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Read Frequently Asked Questions

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. It will help attendees in determining how well your company is positioned to defend your FDA submission.

Why Should You Attend:

This webinar will focus 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. The discussions will focus on proven techniques to address real-world SDTM and ADaM mapping issues relating to FDA submissions.

The session will focus on increasing confidence in FDA submission acceptance testing by thoroughly checking and questioning all details before an FDA audit. Further, to better manage access to SAS Savvy online resources, attendees will be able to download twenty SAS Savvy mind maps and have a free trial SAS Savvy membership.

Areas Covered in the Webinar:

Module 1: Categories of Submission Issues

  • Top Ten Categories: Overall, SAS, SOPs, Training, Specifications, Data, Development, Validation, Audit, Tools
  • FDA 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: Training, Communication, Corrective and Preventative Action Progress
  • Effective KPIs 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

Who Will Benefit:

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 course. In addition, this course is ideal for IT groups supporting FDA submissions. 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

Instructor Profile:

Sunil Gupta is an international speaker, best-selling SAS author, and a global corporate trainer. He is the principal SAS/CDISC consultant at Gupta Programming since 1994. Most recently, he taught both of his CDISC online classes with the University of California at San Diego and SAS Institute India. Mr. Gupta will start to teach the new Sharpening Your SAS Skills online class for UCLA Extension in 2016. In 2011, he launched his unique SAS resource blog, SASSavvy.com, for smarter SAS searches. Currently, SAS Savvy’s membership consists mostly of SAS programmers, university students and pharmaceutical corporate accounts.

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