| Time | Topic | Speaker | |
|---|---|---|---|
| 09:30 - 09:40 | Welcome | Scott Colman | |
| 09:40 - 10:20 | Basics of Cold Chain Management Cold chain management is an essential part of the pharmaceutical industry, ensuring product quality and safety from manufacture to end user. This training offers an introduction to cold chain management, covering critical aspects such as facilities, equipment, containers and vehicles, and the importance of temperature mapping and monitoring. The course also touches on significance of validation and qualification for a robust cold chain system. | Sarantis Kosmas | |
| 10:20 - 11:00 | The Gateway to Computer System Validation Computer System Validation training provides comprehensive insights into the process of ensuring that all IT systems function as intended, meeting predetermined specifications consistently. The training emphasizes the significance of validation, regulatory compliance, methodologies to undertake successful validation, and the role of documentation in maintaining system integrity. | Micaela Costa | |
| 11:00 - 11:10 | Q&A | ||
| 11:10 - 11:40 | BREAK | ||
| 11:40 - 12:20 | Introduction to Transport Validation Transport validation training equips participants with an understanding of the criticality of ensuring product integrity during transit. It covers key elements such as methodologies for validating transport processes, regulatory guidelines, risk management strategies, and the importance of temperature control and monitoring during transportation to guarantee product quality and safety. | Raveshnee Moodley | |
| 12:20 - 13:00 | Introduction to Total Cost of Cold Chain Packaging The total cost of cold chain packaging incorporates various factors, including the cost of insulated packaging materials, temperature monitoring, storage, transportation, validation and qualification. This also needs to account for the cost implications of regulatory compliance, quality assurance, and potential loss due to temperature excursions. The actual cost can vary significantly based on product specific needs, transportation distance, and environmental conditions. | Sarantis Kosmas | |
| 13:00 - 13:10 | Q&A | ||
| 13:10 - 14:40 | Lunch | ||
| 14:40 - 15:20 | Introduction to Digital Quality & Validation Management Digital Quality & Validation Management highlights the integration of digital technology in upholding quality and validation processes. This includes understanding automated systems for quality management, use of digital tools in validation processes, ensuring regulatory compliance in a digital environment, and harnessing data analytics for decision-making, all while maintaining stringent data security and integrity standards. | Sarantis Kosmas | |
| 15:20 - 15:30 | Q&A | ||
