Location: Bellevue Space, Biarritz, France
A3P International Congress
October 15-16, 2019
Investigation based on real cases, resolving regulatory discrepancy and answer to inspection observations related to sterile / aseptic fieldPresented 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.
Presented by: Jim Polarine (STERIS) with Benoit Ramon (Sanofi)
This workshop covers contamination control in cleanrooms applied to sterile processes using a good science based approach. Environmental monitoring, Risk based analysis, Viable and non-viable contamination in cleanrooms, Process design including barrier technologies, Cleaning and disinfection, Aging facilities, Fungal & spore forming organisms, Viral safety, Data integrity, Quality Systems & Quality Assurance, Disinfectant selection & testing. This workshop will help you to improve your knowledge of contamination control through case studies, feedback of experiences, audience interaction in groups, and a Jeopardy game based on contamination control.There will be a lot of audience participation and interaction related to contamination control regulations (eg Annex 1). There will be some critical thinking and risk based analysis of case studies and contamination issues in the cleanroom industry. CAPA investigation will be discussed.
Don’t forget to come see STERIS at booths R16 / 17 / 18/ 19 in the Espace Rotonde.