2nd Annual Sterile Pharma Workshop

Sterile Manufacturing companies today are required to be compliant with stringent FDA regulations with regards to sterility assurance and validation. Under these circumstances, a thorough understanding of the FDA’s expectation from the sterile manufacturing plans becomes necessary. With more and more companies under the risk of being issued with a form 483 and subsequently a warning letter, the importance of ensuring failure free sterility assurance and audits for sterile products & facilities is imperative. Looking at these challenges faced by the sterile manufacturing companies, After the success of the first edition, CPhI brings the 2nd Annual Sterile Pharma Workshop scheduled from 18th – 19th November 2015 in Mumbai, India.

Key Focus of the event:
  • FDA focus during inspections for successful completion of audits
  • Recent PDA guidelines on sterile
  • Quality systems in sterile manufacturing
  • Contamination Control and environmental monitoring
  • Inspection failures in aseptic processing
  • Risk management in sterile manufacturingo

Who Should Attend?
Senior Managers, Senior Executives
  • Quality Assurance
  • Microbiologists
  • Engineering
  • Production


Past Speakers
Thomas J. Arista
Field Investigator
US FDA
Paul Larocque
President
Acerna Inc
Vikram Shukla
Vice President
Zydus Hospira
James Agalloco
President
Agalloco & Associates
*Video Presentation


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