Bringing Risk Based processes into your SDLC

Risk Assessment is now an underlying principle in global regulatory compliance, appearing in both governmental, i.e., FDA, EMA and non-governmental standards such as ISO. Gain an understanding of how, when and where to apply risk assessments to IT compliance processes. Learn how to achieve ROI for the effort in terms of process improvements resulting in reductions in time and other resources dedicated to CSV. Attending this webinar enables “smarter” allocation of Information Technology/systems compliance resources.

Areas Covered in the Session :

  • “Science based” risk assessment processes
  • Benefits of risk assessment, the return on investment
  • Risks and impacts to look for across the Information Technology compliance landscape
  • Applications to Information Technology/systems compliance and testing strategies
Who Should Attend:

  • Technology/systems compliance professionals and direct management
  • Professionals responsible for development and execution of testing strategies
  • Quality Assurance professionals with oversight responsibilities for IT systems or the Quality Management System
  • Information Technology/systems Business, Data and Process Owners


Gail Schumacher

Gail Schumacher’s 20 years of hands-on experience in IT Quality Systems Compliance focuses on Risk Based Computer System Validation for F500 pharmaceutical and medical device companies. Her quality assurance expertise encompasses a deep familiarity with international GxP regulations and the application of risk assessment processes to compliance strategies coupled with a fundamental understanding of IT Systems and the Systems Development Life Cycle.

Gail’s professional practice includes compliance oversight, developing and applying electronic data integrity controls and authoring numerous compliance processes and procedures. She is a change agent, leading cross functional teams in quality process reviews, improvement and implementation. Gail also pre-reviews articles submitted for publication to the Institute of Validation Technologies: Journal of GXP Compliance.

Gail is the founder and owner of Schumacher Consultants, assisting IT Quality Assurance and Compliance professionals in the biotech industry.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance