Issues with Risk Assessments for Parenteral Facilities 2015

Topics

• Setting Limits ADE and PDE (declared synonymous by the EU)
• Briefly review the new regulations
• HVAC
• Why Parenterals are not a problem, viable versus non viable particles
• The issues with Lyophilizers
• Disposables versus dedication or Shared equipment
• Closing powder handling processes
• Why liquids are so much easier that powders
• It`s not just about cleaning

Who should Attend

• Senior Managers in the Quality and Regulatory Areas
• Directors
• Engineering and for CMO Business Development Leadership
• Senior Managers of Operations