Name
Auditing Manufacturers: Linking Data Integrity with Quality Culture
Date & Time
Thursday, November 17, 2022, 10:00 AM - 10:45 AM
Description

Auditing a company to determine if its culture supports quality and data integrity is becoming an increasingly crucial part of inspections.

The FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), the World Health Organization (WHO) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) have all incorporated the topic of a quality culture in their guidances on data integrity in pharmaceutical and medical device manufacturing and clinical trials.

The trouble with a quality culture is determining how to measure it and how to train for it.

Come hear a world-class expert discuss ways you can create a world-class quality culture.

Kara Stockett Quinn
Track
Plenary
Location Name
Gallery 2-3