Location

Productivity and Quality Institute - Alexandria

Objectives

• To give a clear understanding about thermal mapping best practices

Outcomes

• Enhance your understanding of pharma specific requirements in the area of in-transit and/or cross dock storage• Provide insights in practical application and enhance audit readiness• Discuss regulatory requirements, national and international related to storage of Time and Temperature Sensitive Pharmaceutical Products (TTSPPs)• Relate practical insight from mapping study Protocol preparation to final Temperature mapping Report• Select the best strategy for deciding on type and number of EDLMS, where to place control devices according to risk assessment

Course Contents

• Regulatory requirements for storage of medicinal products• General requirements for storage areas for Time and Temperature Controlled Products• Use of Electronic Data Logging Monitor (EDLMS)• Pharma specific storage area requirements• Temperature mapping study preparation and execution