Sterile Pharma Workshop

The recent increase in issuance of warning letters to sterile manufacturing facilities is a key indicator that the FDA guidelines for sterile manufacturing have become very stringent

Due to non compliance with these high quality and safety standards set by the FDA for sterile pharma manufacturing, there is a shortage of sterile drugs across the globe. Leading pharma companies are now looking at India as a sterile manufacturing destination to bridge this gap.

Keeping in mind this tremendous opportunity, CPhI has organized Sterile Pharma Workshop in Mumbai. This two day strategic workshop scheduled on 8th-9th October, 2014 which will focus on ensuring failure free sterility assurance and audits for sterile products and facilities.

This workshop will see Indian and International experts addressing the key issues related to sterile manufacturing by way of case studies, role plays and cross functional situation analysis.

Meet Our 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


Sterility Assurance

  • Avoiding cross contamination by ensuring microbiological controls
  • Identifying critical risk areas

 

Sterility Validation

  • Minimizing gaps / risks in validation master plan / protocol
  • Right first time validation with continuous monitoring to avoid failures

 

Audits in sterile plants

  • Anticipating key focus areas of next audit
  • Identifying non-focus areas that may be audited

 

Format of the technical workshops

  • Workshop day one
    • Breakfast briefing with international expert
    • Sterility assurance
    • Games
    • Case study discussion
    • Group exercises
    • Cross functional situation role play
  • Workshop day two
    • Breakfast briefing with workshop leader'
    • Sterility validation
    • Case studies on top non-compliance areas
    • Games and networking
    • Auditing sterile facility
    • Case studies
    • Audit role play

Key take aways

  • Updates on sterility assurance by international expert
  • Identifying and anticipating specific areas overlooked and identified during regulatory audits
  • Role plays to ensure optimum learning & interaction
  • Workshop format to get all your questions answered
  • Group exercises for classroom learning experience

 

Who should attend?
Senior Managers and Senior Executives from Quality Assurance department working in sterile facilities/drug products (formulations)

Senior Managers and Senior Executives from microbiology, engineering and production department working in sterile facilities/drug products (formulations) may also attend

conference website builder