Cool Chain Brochure 2013.pdf - Sofrigam

pRe-CONfeReNCe WORkshOp Day
mondAy 28tH JAnuAry 2013
Workshop A
Dr. Mary Foster,
Chair, Packaging and
Storage Expert
Committee,
US Pharmacopeia
Workshop B
Andrea Graf-Gruber,
Manager, Cargo Business
Process and Standards,
International Air
Transport Association
(IATA)
Workshop C
Richard Peck,
Senior Program Manager
Life Sciences, EMEA
Professional Services,
Sensitech EMEA B.V.
Paul DellaVilla,
Project Manager Life
Sciences, Professional
Services,
Sensitech EMEA B.V.
Workshop D
Simon White,
Director Quality
Operations, Global
Logistics & Supply,
EMEA Region, Pfizer
9.00 –
12.00
an update of usP general Chapter good Distribution Practices—supply
Chain integrity and industry Comments
A new general USP Chapter Good Distribution Practices - Supply Chain Integrity has been presented in the new issue of the USP
Pharmacopeia Forum (volume 38, edition 2).
Attend this workshop to talk through the important chapters of regulations, with a specific focus on supply chain integrity. The objective of the new
chapter is to ensure product identity, strength, quality, purity, and safety remains intact throughout the supply chain.
The main issue of the new chapter focuses on counterfeited medicines. Here are the topics which are dealt with in detail:
Legal definition of counterfeit medicines (laid down in an EU Directive for Europe, in FDCA, 21 USC 321 § 201 for the USA, inexistent in some countries),
• Types of counterfeit medicines
• Medical consequences of counterfeit medicines
• Distribution (e.g. also via internet)
• How to prepare your organisation for changes to chapter
A paragraph entitled “Best Practices to combat Counterfeit Drugs and Medical Devices” presents a range of measures and possibilities to combat
counterfeit medicines – this workshop will give you an overview of these strategies and how you can implement them.
Some of these measures include;
• Packaging technologies (secured packaging, authentication and serialisation technologies, etc.)
• Establishment of Pedigrees / e-Pedigrees
• Use of 2D bar codes (ECC 200) or RFID tags
9.00 –
12.00
Practical approaches for implementing iata regulations for time & temperature
sensitive air Freight shipments
IATA has been collaborating with supply chain stakeholders to understand and define high-standard requirements for time and temperature
sensitive air freight shipments.
This workshop will examine practical approaches to sensitive healthcare products transport and how to comply with the Perishable Cargo
Regulations (PCR) Chapter 17, including IATA labels. The workshop will assess the current challenges in perishable air freight and discuss how
these challenges are addressed in the regulation to ensure communication, processes and standards are in place to maintain the integrity and
quality of the time and temperature sensitive products along the PCR supply chain.
The workshop will discuss:
• What is the feedback of the industry on the implementation of the IATA Time and Temperature label?
• Is the industry ready to implement end to end standard processes?
• The IATA’s Road Map for 2013
12.30 –
15.30
the use of time and temperature generated Data to Create Meaningful KPis,
Enabling a greater understanding of the supply Chain, Helping to safeguard
Product integrity
Time and temperature data related to the distribution of temperature-sensitive medicinal products is an important element of a company’s quality
initiatives. Throughout the supply chain, there are many unforeseen and uncontrollable factors that can cause products to be exposed to temperatures
outside of their acceptable range for storage and distribution. These variations, if not managed carefully, may result in expensive and time-consuming
quarantine processes, product loss, or at worst, harm to the end user.
Utilising a comprehensive data storage management tool capable of generating reports linked to Key Performance Indicators (KPIs), enables
managers to review the current state of the supply chain, assessing various risks, whilst delivering critical notifications to managers in quality,
logistics, distribution, warehousing, etc… These reports allow for the implementation of fast and effective preventative measures thus minimizing
risks in the supply chain.
The workshop will focus on two objectives:
1) Look at industry best practices and the pitfalls of data collection and report generation, then;
2) Outline the methods used to set up appropriate data collection processes enabling the development of meaningful KPIs, demonstrating how
certain KPIs can be used to support continuous process improvement.
12.30 –
15.30
Keeping up with the EMa: Controlled room temperature requirements
This session will lead you through the top 3 anticipated challenges relating to the GDP updates. Simon is actively involved in tracking feedback for
the GDP developments and will address each individually before assigning a crisis case study to you in groups. The challenges;
1.Distribution under controlled room temperature
Controlled room temperature implies a certain degree of control over the temperature of the storage conditions and a continuous temperature
monitoring system is required for the storage of medicinal products.
2.Segregation of product
Many Distribution Centres export globally, what is the purpose and benefit of segregating EU product from non-EU product? What is considered
a definition of ‘segregation’ (physical, electronic, both...)? All finished product batches can be considered segregated since they are – as A GMP
requirement - packaged, identified and managed in such as a way to avoid cross-contamination with other product, whether for use in humans or
animals and irrespective of the indication for use.
3.Intermediaries
What is the industry’s oversight protocol for Intermediaries in the distribution process, carriers, freight forwarders etc.? What is the most effective
quality oversight method for service providers, expectations, who should be responsible...?
Your Task;
You will be presented with a real life case study and must work through possible solutions in your group. Each group will then feedback to the whole
workshop and you will walk away with brand new strategies!
RegisteR NOW
phONe: +44 (0) 20 7368 9300 email: enquire@iqpc.co.uk WeB: www.cooLcHAineurope.com