Computer Systems Validation & Software Assurance University

Philadelphia, PA Philadelphia, PA

From the event website: With FDA’s heightened focus on Software Assurance and Data Integrity – Computer Systems Validation has taken on a new movement initiated by regulatory authorities. In fact, FDA has taken the lead with a proposed guidance on Computer Software Assurance and is asking firms to rethink their approach. With that said, the [...]

Stability Operations for Drugs, Biologics and Medical Devices; Steps to a Successful Stability Function

From the event website: This 12-hour accredited course focuses on the operational aspects of the stability function as practiced by the pharmaceutical, biological and medical device industries. Establishing and maintaining strong stability operations programs will be covered, including: SOPs, training, protocols, life cycle stability strategies, storage conditions, chamber maintenance, and monitoring, trending data and sample [...]

KENX Laboratory University / PSDG 2023 Meeting

San Diego, CA San Diego, CA

Stability Testing and Program Management. More information coming in the future. Advance information contacts: Program: John O’Neill Registration: Howard Wilensky