This seminar will help you understand in detail the application of FDA’s guidance on the use of social media with computer systems subject to FDA regulations.  This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.  It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

The use of social media can vary, and the approach to ensuring compliance should be based on the specific case and the risk associated with it.

Course Objective:

• Gain an understanding of FDA’s guidance on the use of social media
• Develop the ability to apply FDA’s guidance on social media when implementing, validating and maintaining computer systems in your organization
• Understand the best practices for maintaining a computer system to be used in conjunction with social media in a validated state
• Discuss the best practices necessary to ensure all systems with functionality related to social media are validated appropriately
• Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, as it applies to the use of social media capability
• Understand how to effectively document the process of computer system validation where social media capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated state
• Learn how to gain information about trends in validation related to the use of computers and social media, as industry progresses and new best practices emerge
• Understand some of the key “pitfalls” to avoid when employing social media capability in an FDA-regulated environment

Course Outline:

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Validation Strategy
• System Risk Assessment
• GAMP 5 “V” Model
• Use of Social Media in an FDA-regulated Environment

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers