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.
Audits in sterile plants
Format of the technical workshops
Key take aways
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