Successful Computer System Validating and Control Using Managed Services SaaS, and Cloud Based Platforms

The use of Managed Services, Systems as a Service (SaaS) and “Cloud” providers are becoming more popular choices for hosting and managing IT systems. Understanding the risks and responsibilities that come from using these choices for Quality Systems used for Regulatory purposes becomes ever more important. Learn more about taking advantage of the benefits gained from employing these options while maintaining control of validated systems.

Areas Covered in the Session :

• Who’s responsible for compliance – Contacting Company or the 3rd party supplier? Who gets the “observation”
• Supplier evaluation and selection
• How to maintain control of your quality systems
• Audits
• Leverage the Supplier’s processes and system documentation

Who Should Attend:

• Technology/systems compliance professionals and direct management
• Quality Assurance professionals with oversight responsibilities for IT systems or the Quality Management System
• Information Technology/systems Business, Data and Process Owners
• Professionals responsible for service procurement contracting

Course Director: 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.