Overview: This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance. What makes this session unique are the real life examples that make application of the techniques understandable in the context of any validation project. It includes a workshop for participants to perform their own hazard analysis so they are proficient in applying the risk-based techniques.
Areas Covered in the Session:
Interactive real life examples.
How to identify risk and establish mitigations.
How to use the hazard analysis to make validation efficient.
How to document the risk assessment using a template
How risk assessment reduces validation time.
Determine risk in a process to reduce the testing effort.
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.\r\n\r\nGlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.