Data Integrity and Computerized Systems - Meeting FDA Expectations

Tue. February 28| 11:00 AM - 11:45 AM | Conference Program | Room 122A PACK EXPO East

Speaker: Paul Labas, Dir., IT Compliance and CSV, IPS-Integrated Project Services, LLC

In 2015, the US Food and Drug Administration (FDA) cited data integrity issues in 85% of its warning letters, with the vast majority applicable to electronic data and systems. The trend continued through 2016. This workshop examines the current regulatory landscape and latest enforcement trends, and defines the steps that companies must take to meet FDA expectations.

Fifteen years of life sciences compliance and quality assurance experience with specific emphasis on computerized systems compliance and validation, and electronic data integrity. Proficiency with FDA 21 CFR Parts 11, 210/211, 820, EU EMA Annex 11, ISPE GAMP 5, FDA GxP, FDA and EMA guidance, IEEE and ISO Standards, SDLC and VLC models, infrastructure qualification, FMEA, etc. Experience with high criticality efforts such as system validation and quality measures deployed to meet FDA Consent Decree obligations, systems in use by 100,000+ worldwide users, etc.

Type: Healthcare Packaging and Processing Conference

Cost: $95 by Feb.10 / $130 after Feb.10

Track: Life Science Processing


Labas , Paul Director, IT Compliance and CSV, IPS-Integrated Project Services, LLC | Role: Speaker