Data Integrity Trends and Analysis

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:

Hovsep 85x105Hovsep Kirikian is a 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.

 

 

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…
See all Testimonials