Audit Trails and Data Integrity in Pharmaceutical and Life Sciences

On today’s episode, Stacey Bruzzese welcomes Ivan Soto, Director Manufacturing Validation for Emergent BioSolutions. They discuss a variety of aspects around the topic of data integrity.

 

Why are we hearing more about audits and audit reviews lately?
Ivan talks about the history of audit trail reviews and the current challenges
Why are audit trails important to safety, efficacy and reliability or pharmaceuticals and how does that impact data integrity efforts?
Why is it important to assess the products’ entire legacy or history?
Ivan shares advice on the frequency of periodic reviews and what should be included in those reviews
He shares some tips for simplifying the review process
Where does Ivan see the industry moving regarding audit trails?

Ivan has been in the life science industry for over 20 years and held several technical and management positions at different Pharmaceutical companies in the areas of Validation, IT Compliance, Quality Control and Quality Assurance. In his previous role under his leadership, his team successfully implemented a lean validation program. He is an active speaker at conferences related to validation cost reduction and efficiency improvements. He is also a contributing editor for the Journal of GxP Compliance and Validation Technology. He has a (B.S) in Chemistry from the Catholic University of Puerto Rico.

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