In the 30-minute recording Marc Holfelder, Managing Director LA2 GmbH and our guest speaker Christian Alexander Graf, Quality Assurance & Statistics, talk about the following topics:
After a total of 71 FDA Warning Letters with findings on data integrity were sent out between January 2014 and January 2016, the FDA drafted a draft document on this subject in April 2016. Further documents exist from the British MHRA and the WHO. This webinar provides information on the influencing factors that can jeopardize data integrity, what ALCOA+ does, and why humans play a decisive role alongside technical considerations. The speakers also clarify the terminology and give tips and recommendations on how to prepare for future audits.