Webinar: Integrating Data Integrity Requirements into Manufacturing and Packaging Operations

You are invited to attend a webinar sponsored by the PDA Delaware Valley Chapter on integrating data integrity requirements into manufacturing and packaging operations 

This presentation will review the basic issues of Data Integrity and will include important elements of the recently released PDA Technical Report on Data Integrity.  Whether manual or electronic data, whether the integrity of data is lost due to unintentional, intentional or careless reasons, data is a valuable asset to the organization and needs to be properly managed.  A key difference in this Technical Report from the previous Technical Report on Data Integrity in the Laboratory is the development of a risk tool for evaluating the risk to Data Integrity, which will be highlighted in the presentation.

The presentation will be given by Mr. Chris Smalley. Chris is a consultant for Valsource, focused primarily on Compounding Pharmacies. His expertise includes Single Use Systems and Aseptic Operations. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally.  His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager.  Chris is a graduate of the Philadelphia College of Pharmacy of the University of the Sciences in Philadelphia.  His graduate education includes a MBA from Temple University Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from Temple University School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University. Chris has been a member of the PDA Board of Directors, as well as a member of the PDA Science Advisory Board.  Currently he is a member of the ISPE Disposables CoP.

Agenda

7:00-8:00pm  - Presentation

8:00-8:30pm - Q&A