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On-Demand Workshop

A review of the Data Integrity related 483 warning letters issued by the FDA in 2017, this webinar will identify warning letter trends and common data integrity issues impacting the life sciences industry, how to identify potential data integrity risks, and proactive remediation strategies.   

The discussion will include:
  • Evaluation of 2017 Warning Letters and trends regarding Data Integrity
  • Case studies of actual warning letters and remediations
  • How to minimize risk of receiving a data integrity related 483 Warning Letter
  • Live Q & A session

About the Presenters:

Diane Gleinser

Senior Vice President of Life Science Services and 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.

Hovsep Kirikian

Project Manager at USDM Life Sciences Hovsep has over 12 years of experience managing projects in the life science industry, with specific focus on regulatory compliance, validation, equipment lifecycle & sustainability, laboratory operations and data management across all phases of the product life cycle.

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