Compliance Industry Trends: Evolution of Managed Services

On-Demand Workshop

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:

Mike Canale 85x105Michael Canale is the Vice President of Compliance Wellness at USDM Life Sciences. Michael 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.

 

Diane Gleinser 85x105 rightDiane Gleinser is the Senior Vice President of Life Science Services and Solutions at USDM Life Sciences. Diane has more than 27 years of experience in life science based industries, encompassing quality assurance, quality control, validation and regulatory compliance for research and development, clinical affairs, manufacturing and packaging, laboratory setup and analysis, and auditing under cGMP, cGLP and cGCP regulations and 21 CFR Part 11.

 

 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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