Pharma Microbiology Summit

We are pleased to invite you to the Pharma Microbiology Summit, scheduled for June 13th - 14th, 2018 in Vienna, Austria.

IIn the face of growing challenges and changing the regulatory landscape in the pharmaceutical industry, this event will enable the pharma microbiology community to get an interdisciplinary grasp and tackle trending topics such as low endotoxin discovery, mycoplasma manifestation, and sterility assurance in combination products.

In addition, our unique knowledge sharing platform will attempt to bring a fresh perspective to the microbiology profession, by peeking into case studies that go beyond the conventional discourse in pharma gatherings.

Join us in Vienna for this vital discussion on creating operative frameworks for a faster time to market and methodologies for impeccable product safety alongside regulatory, quality and manufacturing experts!

Key Practical Learning Points of the Summit:

  • Regulatory updates from the EU and US pharma policy makers
  • Breaking down The New Annex 1: what to expect and how to prepare for it?
  • Delivering on data integrity in microbiology: what are the regulators’ expectations?
  • Mycoplasma safety testing in biopharmaceutical manufacturing: current regulations, challenges, and trends
  • Quality control: microbial detection methods, water contamination prevention, and endotoxin testing
  • Promises and pitfalls in the field of endotoxin: low endotoxin recovery
  • LER case studies from a CMO perspective
  • Monocyte activation test - raising the standards of pyrogen detection
  • Cell line-based MAT for pyrogen detection in routine quality control
  • Success factors for aseptic fill/finish manufacturing
  • Use of investigative techniques for environmental monitoring problem solving
  • Advanced aseptic processing with isolators and RABS
  • Global sterility assurance strategy for a combination product across three continents
  • Microbiologist, a key player on the shop floor: series of case studies
  • Boosting innovation in pharma microbiology: surpassing regulatory and intellectual property restrictions
  • Preparing for the future of drug evaluation and safety assurance

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders Managers, Senior Managers, Scientists, Chemists, Technicians and Fellows specialising in:

  • Microbiology
  • Biotechnology
  • Drug Development
  • Product Innovation
  • Parenterals
  • Biopharmaceuticals
  • Combination Products
  • Aseptic Manufacturing
  • Non-Sterile Manufacturing
  • Sterilization
  • Fill/Finish
  • Validation
  • Quality Assurance
  • Quality Control
  • Bioprocess
  • Process Monitoring and Control
  • Upstream Process Development (USP)
  • Downstream Process Development (DSP)
  • Secondary Operations
  • Contamination Control
  • Risk Management
  • Environmental Monitoring
  • Facility Management
  • Clean Rooms
  • Corrective and Preventive action (CAPA)
  • Current Good Manufacturing Practice (cGMP)
  • Good Laboratory Practice (GLP)
  • Regulatory Affairs
  • Compliance
  • Business Development