The Program

Day One
Monday 19 October, 2009

Registration

Opening remarks from the Chair

Opening Keynote:
Complying with Guide 069: the temperature control of drug products during storage and transportation

• Reviewing the content of Guide 069
• Analysing the major changes that will have to be implemented in Autumn 2009
• Identifying what departments will be affected by these new requirements
• Effectively managing your suppliers to ensure compliance
• Recommendations for achieving compliance fast

Understanding and Applying the USP <1079> Revised Guidelines

• Outlining the new 1079 Chapters for implementation
• Comparing the main changes with the previous version
• Specific protocols for receiving, shipping and storing temperature controlled pharmaceuticals
• Using examples and grids to demonstrate how to use the guidance to make decisions for your cold chain management

Case study:
Tightening the screws: ensuring global import/export compliance

• Import/export compliance and the pharmaceutical industry
• The evolution of biopharma and trade compliance
• Understanding cross-border requirements
• Implementing an effective strategy to ensure compliance and speed global distribution
• Real life examples

Towards global standardisation: reviewing air, sea and land transportation requirements for ensuring efficient and effective cross-border distribution

• Exploring current global regulatory requirements and guidance for temperature sensitive products
• Comparing and contrasting regulations and procedures which countries and regions have the best practices?
• Reviewing international packaging regulations
• Expanding your supply chain into emerging markets
• Practical strategies for ensuring compliance

Morning refreshments

Using technology to improve the temperature monitoring process

• Addressing the key constraints within current industry practice
• How these were addressed using available technology
• Critical success factors for the project
• Improvements and benefits to the supply chain

Cargo security programs and their impact on pharmaceutical shipments

• Government programs for Cargo Security  (CTPAT, AEO, CCSP)
• Cargo theft prevention programs
• International Mutual Recognition
• Cost to Implement
• Implementation of cargo security programs
• Benefit of Implementation
• Government Agency interaction

Lunch

Understanding active temperature-controlled shipping solutions

Optimising the cost effectiveness of transportation: shipping by road and rail versus air

• Regulatory bodies, manufacturers and suppliers: discussing techniques for complying with international requirements fast
• Developing sustainable development processes: reducing waste and protecting the environment while ensuring the integrity of your cold chain
• Implementing cost effective and efficient processes throughout your cold chain
• Employing effective risk management strategies to ensure quality
• Incorporating temperature monitoring devices into the packaging process
• Cold chain practices for large scale distribution
• Effectively validating and qualifying the cold chain

Managing cold chain excursions for clinical supplies

• Understanding the impact of temperature excursions on the shelf-life of your product
• Establishing a risk management approach for desired temperature maintenance
• Leveraging your IVRS to manage cold chain
• Implementing an auditing process with your suppliers
• Sharing experience with partners and clients to implement better practices
• Choosing a monitoring device to prevent erroneous temperature excursion reports

Implementing automated temperature monitoring to improve clinical distribution processes

• Effectively using the scientific data available for a product
• Evaluation of a temperature monitor to distribute clinical supplies
• Mapping the distribution plan for a product and preparing clinical sites and depots to utilize updated technology
• Implementing shipping containers and temperature monitoring devices
• Demonstrating the value of using technology in real-time

The critical importance of validating a cold chain procedure

• Agreeing upon a concrete definition for validation
• Standardising the definitions of both qualification and validation
• Ensuring shipping packs are suitable for the contents
• Managing frozen products (-196°C to -10°C) in comparison to products required to stay at 2 to 37°C
• Practical steps for validating and qualifying the cold chain to ensure quality

Closing remarks from the Chair and close of day one

ALMAC drinks reception

Unwind and discuss the day’s presentations with your peers at this exclusive networking event.

Day Two
Tuesday 20 October, 2009

Registration

Opening remarks from the Chair

Nigel Cryer,
Head of Quality Manufacturing and Supply Chain,
Norgine

Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to a current aspect of cold chain storage and distribution.

Lunch

Keynote presentation:
Bracketing mass, time and temperature in the design and operational qualification of active and passive shipping containers

• Packout design parameters: quality and regulatory factors
• Evaluation of the products to be shipped: packout configuration, stability data, excursion design
• Route analysis: handling, touch points
• Time bracketing: buffering the timeline accurately
• Temperature mapping: data acquisition, historical information
• Quantifying minimum and maximum mass and volume load
• Standardization of the qualification report to cover the bracketed parameters

Panel discussion: Ensuring the integrity and the quality of your ambient temperature products under different climatic conditions

• Ensuring that your colleagues and partners are up-to
• date with the increasing regulatory demands of ambient
• temperature-controlled product distribution
• Collectively defining how to best handle these increasing
• needs for transportation and logistics
• Expanding risk assessment, stability data and deciding on
• safety margins
• Exploring the applicability of Mean Kinetic Temperature (MKT)
• Implementing best practice approaches to controlling
• ambient temperatures for long durations

Afternoon refreshments and exhibitor card prize draw

Nigel Cryer
Head of Quality Manufacturing and Supply Chain
Norgine

Optimising the monitoring of the cold supply chain

• Discussing the problems and benefits of using different logistics suppliers
• How to co-ordinate your monitoring
• Ensuring a good quality cold-chain with good communications with your logistic suppliers as well as in-house

The validation life-cycle for shipping: an approach to managing planning documents

• The use of development testing
• Defining temperature requirements (stability vs. in-house storage)
• Conducting effective risk assessments
• Auditing and the use of vendor documentation
• Planning for the type of equipment used (single use, leased or company owned)
• Strategy for initial validation documents (IOQ and PQ)
• Deviation planning
• Validation maintenance

Closing remarks from the Chair and end of the conference