Location: Bellevue Space, Biarritz, France
A3P International Congress
October 15-16, 2019
9h 30 | WORKSHOP | Wednesday, October 16
Investigation based on real cases, resolving regulatory discrepancy and answer to inspection observations related to sterile / aseptic field
Presented by: Walid El Azab (STERIS) with Olivier Chancel (MERIAL)
This workshop will discuss various topics with a specific focus on EU GMP Annex 1. In addition, four different Authorities observations (ANSM, EMA or US FDA) will be shared as part of the process of making observations aseptic / sterile aspects with two real case studies (environment, manufacturing tools, aseptic behavior, water loops.
This workshop is intended for anyone involved in aseptic / sterile field. It will allow participants to discover various situations that can take place everywhere, even "at home" ... Under realistic conditions, the workshop will lead participants to conduct an investigation, to seek together not only the causes, but also the root causes of the deviation in order to prevent them efficiently. For this purpose, suggestions arising from root causes will be proposed. The workshop will be broken down, whenever it is possible, to illustrate the experience of the future review of the contamination control strategy.
Visit STERIS at Stands R16 / 17 / 18 / 19