View, browse and sort the ever-growing list of sessions by pass type, track, and format. With this Session Scheduler, you can build your schedule in advance and access it during the show via export or with the Mobile App, once live. Sessions do fill up and seating is first come, first serve, so arrive early to sessions that you would like to attend.
Tony Pezzolo (Practice Manager, Compliance and Validation Services / Global CSV SME, PerkinElmer)
Date: Wednesday, May 1
Time: 2:15pm - 3:00pm
Track: Drug Manufacturing
Vault Recording: TBD
Validation of computerized instruments is not a one-time activity but viewed and approached as a lifecycle, including commissioning, change control/maintenance, and retirement. Computer System validation is an integral part of this process. As the regulations on validation grow in complexity, their interpretation and response is not uniform in the industry. As such, many SDLC & CSV policies are over-engineered, inefficient, and as a result, the time and cost of commissioning and maintaining new equipment can grow exorbitant. Best practices need to be deployed that allow for flexibility and streamlining. In other words, compliance is no longer enough – every company needs an SDLC program that allows the business to move quicker and reduce instrument down time.