Application of Disinfectants and Sterilants to Control Microorganisms; FDA Endotoxin Test – Understanding the Latest Revision 2015

Topics

• Determining the vendor qualification requirements
• Determining the implementation aspects of a cleaning and disinfection program
• Determination of how application schedules apply to commissioning of a facility and after a shutdown
• How to develop an application schedule
• Impact of product expiration dating and regulatory implications
• The impact of sanitizers, disinfectants and sporicides on various common microorganisms found within a pharmaceutical facility
• The regulatory expectations of sanitizers, disinfectants and sporicides
• The use of coupons and liquid suspensions their advantages and disadvantages
• Resistance and rotation of disinfectants and its meaning to facilities
• Monitoring and interpretation of the results of the cleaning and disinfection program

Who should Attend

• Product Development
• Manufacturing
• Quality Assurance
• Project Management
• Regulatory Affairs
• Quality Control
• Validation
• Regulatory Compliance