Data Integrity and Data Governance in GMP - Latest Regulatory Trends

ABOUT THIS WEBINAR

This webinar provides an overview about inspection trends and latest industry guidelines in 2023 (and beyond).
We will check FDA's inspection database and uncover some recurring inspection topics in 483s and Warning Letters such as Vigilant Monitoring (using data), completeness of manufacturing data and issues with third parties.

We will investigate the hot topics for the future guiding us away from Data Integrity as a "compliance activity" towards data as the enabler for knowledge management and Quality Intelligence.

AGENDA

Inspection Overview FDA and EMA
Regulatory Guideline Updates
483 Findings
The Intas Case: The next Chapter
What do we expect next

ADDITIONAL INFO

When: Monday, March 11, 2024 · 4:00 p.m. Berlin
Duration: 1 hour
Price: Free
Language: English
Who can attend? Everyone
Dial-in available? (listen only): Not available.

FEATURED PRESENTERS

1678717378-522f93d5a11bbeb6

GxP-CC

Tame Compliance, Avoid Penalties, & Trim Costs

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1605113543-0ddd85f9c52bd4f3

James Francum

CEO

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Webinar hosting presenter Ulrich Köllisch

Ulrich Koellisch

Partner

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