News | October 19, 2015

Aseptic Manufacturing: Do Engineers And Microbiologists Speak A Common Language In Order To Achieve The Drug Excellence Goal?

Source: Fedegari Group

Background

A real synergy (and not just in words) between the main professionals involved in the production processes is essential to get quality products.

In the reality, this does not always happen. Sometimes Quality Assurance Dept and Engineering seem to speak two different languages when it comes to aseptic manufacturing!

ASCCA is organizing a seminar at the headquarters of Fedegari Albuzzano with Italian and international speakers from the pharmaceutical world, end users, designers and process equipment manufacturers. At the end, a tour of Fedegari facilities is planned.

Speakers

  • Claudia Roth (Vetter Pharma, Germany)
  • Ian Symonds (Head Aseptic Quality - GSK)
  • Gilberto Dalmaso (Particle Measuring Systems)
  • Conor Murray (Contamination Control Expert, Ireland Convenor Biocontamination Working Group CEN 243 -WG-5)
  • Patrizia Muscas, Michele Zavaglia (Eli Lilly Italy)
  • Pier Angelo Galligani (Techniconsult Italy)
  • Sergio Mauri (Fedegari Group)
  • Roberto Maglio, Soffiantini Roberto (IBSA Italy)

Learning Objectives

  • The universal language of engineers and microbiologists
  • Aseptic manufacturing: needs and future expectations
  • QbD, ICH Q9 and Q10 requirements relevant to a sterile production
  • The new relationship, coexistence and intersection of Non-Viable (Engineers) and Viable (Microbiologists) contamination control in aseptic manufacture
  • Building, utilities, process integration and timelines: essentials factor to face critical projects for sterile productions
  • The use of robotics within process automation leads to lower risk of personnel induced contamination
  • Case study: RABS vs. Isolators; discussion of the engineering and microbiological challenges
  • Case study: Rapid Microbiological Methods (RRM) for controlling material transfer into a RABS

Target Group

This ASCCA Conference addresses those employees from the pharmaceutical industry involved in the engineering and microbiological dept., especially from the areas

  • Engineering / Production
  • Quality Assurance
  • Qualification/ Validation
  • Microbiology

For more information: http://www.fedegari.com/news/events-exhibitions/aseptic-manufacturing-engineers-and-microbiologists-speak-common-language-i68

Source: Fedegari Group