Programme Day Two

Case study: Outlining the key elements of temperature and quality management and how these contribute successfully to your overall distribution strategy

• Identifying what a pharmaceutical company aims for in terms of successful temperature management in accordance to current regulations
• Highlighting which solutions are in place by temperature control solution providers and exploring future trends to optimise the outcome
• Learning how to ensure effective quality management by
  • Developing internal cold chain guidelines and updating quality agreements
  • Establishing detailed cold chain documentation according to regulatory requirements
  • Auditing cold chain capabilities and qualifying shipping lanes and road and air transportation equipment
• Uncovering how to implement these successfully in your overall distribution process map and distribution strategy

Overcoming challenges related to the control of frozen shipments and uncovering solutions to validate reliable freezers and qualify shippers

• Presenting regulatory developments and trends with respect to frozen shipments in Europe
• Finding the right technology or solution provider who is able to develop a freezer system that matches your needs
• Establishing ways to validate your packaging and freezing devices successfully in order to ensure integrity of your products at all times
• Qualifying shippers that are able to guarantee safe handling and delivery
• Analysing defrost cycles of the products in order to establish when the product quality is jeopardized in case of failure of the cooling system

• Identifying approaches to remedy the breakdown of a freezing system to ensure the temperature is kept within the required limit

Case study: Dealing with temperature excursion successfully in a challenging environment

• Addressing the Italian logistics system to explore and understand characteristics and challenges
• Outlining temperature excursion risks and potential issues for biotech drugs and vaccines
• Explaining selected systems and solutions to ensure the maximum safety level

• Debating the trends of cold chain logistics and exploring new solutions of some of the main players

Implementing cold chain controls from manufacturing to distribution for cold chain pharma products

• Understanding national and international regulations on temperature requirements in terms of ambient, 2-8°C or dry ice shipments
• Evaluating acceptable excursions based on stability data
• Assessing distribution and production scenarios from the manufacturing site to the last mile
• Identifying the risks and challenges on each distribution level and establishing strategies to overcome them cost-effectively
• Implementing lean documentation practices to support the quality of the product
• Checking that all shippers are well informed about product handling requirements and implementing a monitoring system to ensure product safety

Managing cold chain and ambient storage facilities to actively preserve valuable supplies

• Electronic vs. mechanical temperature monitors: which perform best?
• Assessing how to implement adequate temperature monitoring in a study site
• Outlining best practice temperature control methods: ambient and temperature specific product distribution
• Managing deviation and guaranteeing your product stability through comprehensive temperature control and monitoring strategies

Outlining the cold chain distribution of medical samples: what are options, challenges and how to overcome them

• Presenting the different existing options for the distribution of medical samples
• Clarifying the regulatory requirements and how to ensure compliance
• Describing options of storage and assessing the pros and cons
• Exploring current ways of transportation and addressing issues faced
• Explaining the equipment used
• Clarifying which parts of the process can be qualified and how to achieve full qualification
• Identifying how to optimise the process by quality issues management

Reviewing airfreight shipment of cold chain products using PAG shippers

• Identifying the system design and temperature specification of the product
• Assessing shipping lanes and routes to be considered and how to qualify them
• Exploring the challenges to keep the temperature stable within the specification of 2-8°C and how to overcome them
• Outlining the options of green credentials for cold chain products and how to secure them