09.13.21
The 2021 Science Symposium will be held virtually on Oct. 26-27. The annual event gives the industry a chance to learn, network, and engage with colleagues and speakers on game-changing insights facing microbiology, quality assurance, safety and the environment.
This year’s Quality Assurance Workshop will feature a session on remote data integrity auditing of critical suppliers. John Avellanet, managing director and principal consultant, Cerulean Associates LLC, will walk attendees step-by-step through how to conduct a remote data integrity audit of critical suppliers and their own company.
The same approach to evaluate your suppliers can be applied to evaluating the data integrity practices of your own company, (e.g. the effective use of risk assessment, how to manage various virtual records in order to maintain compliance, and what qualifies as a good manufacturing practice record in a virtual workspace.)
Avellanet will also review the items to request when first discussing and scheduling the audit with a supplier; the records to request throughout the audit; the specific items to verify during virtual data system walkthrough; and – using a brief series of questions and a table of audit focus – how to decide whether or not an eventual onsite audit will be necessary.
Avellanet trains U.S. Food and Drug Administration and Health Canada inspectors and district officers on advanced data integrity inspection techniques and detecting data fraud. He has served on behalf of the U.S. Department of Justice as the independent overseer for corporate integrity agreements, served as the industry reviewer for multiple international standards and has authored several books.
To register, click here.