PDA New England Chapter Webinar: Integrating Data Integrity Requirements into Manufacturing Operations

This webinar will provide attendees with an overview of PDA Technical Report 84 on how to integrate the data integrity expectations of global regulators to pharmaceutical manufacturing operations. It will outline how to assess your current manufacturing operations to determine the criticality of the data, the vulnerability of the data given the current processes and evaluate the current controls in place. The result of this exercise will allow you to understand your current data integrity exposure in your manufacturing operations and where additional controls may need to be put in place.

Speaker Information:

Anthony C. Warchut retired from the U.S. FDA in 2006 as a Captain in the U.S. Public Health Service. He spent nearly 30 years as a New England field investigator specializing in pharmaceuticals. After leaving the FDA, he spent 13 years with an international consulting company providing clients with services to improve their quality systems to be in compliance with FDA regulations, prepare for inspections and assist after FDA Warning Letters and Consent Decrees. In 2019, he established his own consulting company. He is an author of PDA TR 84. He has a B.S. in Zoology and a M.S. in Environ. Health Sci. from the URI.