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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

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