For the past decade, Life Science companies have been dealing with rising Computer System Validation (CSV) and IT compliance costs by implementing risk-based processes and leveraging lower cost resources. However, the anticipated benefits of lower costs, a decrease in regulatory compliance risk, and maintaining high quality have not materialized as anticipated. Companies are now turning towards a Managed Services approach, which includes defined performance and service levels that are tied to financial agreements.
Join this workshop to learn about the evolution of Managed Services for CSV and IT compliance.
The discussion will include:
- How Life Science companies are moving towards a Managed Services model
- Benefits and challenges of typical Managed Services programs
- A recent Case Study
- Live Q & A session
About the Presenters:
Vice President of Life Science Solutions Diane has more than 29 years of experience in the life science industries. As a member of the senior management team at USDM Life Sciences, Diane leads a highly skilled team of implementation and compliance engineers and was instrumental in establishing USDM's Regulatory Compliance focus.
Vice President of Regulatory Compliance Mike has more than 20 years of experience providing strategic information management and regulatory compliance consulting services within the Life Sciences industry, including the implementation of quality and compliance programs, policies, and guidance in the areas of Computer System Validation, Auditing, Risk Management, and 21 CFR Part 11 compliance.