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12.30 20140917 IATA Cool-Chain-Association Regulatory-Standards
12.30 20140917 IATA Cool-Chain-Association Regulatory-Standards
Ronald Schaefer
September 17th, 2014
Cool Chain Association, Milan
Agenda
IATA Standards: Ensuring compliance to Regulations for Time & 2 Milan, September 17, 2014
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IATA & Air Cargo
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About IATA
Founded in 1945. With 240 members, IATA represents 84% of global air
traffic
IATA’s mission is to represent, lead and serve the air transport industry
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About Air Cargo
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Industry Cooperation
The Time and Temperature sensitive goods play an important role in this
percentage
Live
E-Cargo
Animals Speed to market is therefore
Special essential and the healthcare
Cargo
(ULD, industry is increasingly dependent
Mail) upon air cargo.
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Industry Cooperation
Why is air cargo so important?
Immunization prevents
2.5 million deaths every year
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Regulations &
Standards
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IATA a standard setting organization
IATA adopted a supply chain approach by liaising with all stakeholders
…
Temperature
Sensitive
IATA
Products Cargo Services Conference (CSC)
Ground Temperature
Freight
Shippers Handlers Airlines Airports controlled
Forwarders packaging
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IATA a Standard Setting Organization
…from the health care industry to establish common standards
Temperature
Sensitive
Products
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Background: Pharmaceutical Product Logistics
The pharmaceutical industry has relied heavily on the airline industry for
its speed and efficiency but air cargo’s share of global pharmaceutical
products transport has dropped
Over the past 10 years, air carriers, handlers and Air cargo’s share of global pharmaceutical
freight forwarders have responded with branded products transport (in %)
products and services to grab a share of this
lucrative and niche market. 17
+35°C -10°C
+35°C -10°C
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Air Cargo Supply Chain Challenges
The process is quite complex and shippers have difficulties to identify
stakeholders that meet standards and regulations
Example of Flow from BRU to SYD
Ground handler BRU Airline BRU – SIN - SYD Ground handler SYD
… to identify and recognize the best Certify and then register best
players players on a publicly website
Advocate for Develop training Develop pre- Manage deployment Manage database
globally accepted contents validation of validators of validated
standards and Develop assessment toolkit Audit documentation, locations and
regulations assessment criteria Develop a standard processes and operators
Establish validation for instructors and validation operations Manage re-
checklist with validators exam methodology and consistently validation schedule
industry Train instructors, assessment tool Manage quality of
Establish industry validators and validations
steering group industry Follow-up
stakeholders Award and recognize
Manage database operators and
of certified locations as "CEIV
instructors and Pharma certified"
validators
Additional
Training: IATA Pharmaceutical Handling Diploma
Training
Assessment
CEIV Pharma
encompasses various regulations and standards e.g. EU GDP.
includes in the check list the GDP requirements.
aims at covering international standards and country-specific requirements.
aims at reducing the number of audits or simplifying them.
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Assessment
CEIV Pharma is looking at a global and consistent GDP+ certification as
the “GDP” is very EU centric and not specific to air transport.
Assessment
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Validation
Validate if recommendations have been implemented
Validation
On-site visit by Independent Validators to review progress made against recommendations during the
assessment phase.
At the end of validation decision on whether all requirements have been fulfilled
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Training: IATA Pharmaceutical Handling Diploma
The diploma includes 4 pharmaceutical specialized courses. Upon
successful completion of the 4 courses, the participants will obtain an
IATA Diploma.
Training: IATA
Pharmaceutical Handling
Diploma
2 key personnel involved in handling pharmaceutical products activities should be trained and pass
the examination of the 4 courses of the “IATA Pharmaceutical Handling Diploma” - before the
certification
Additional Training
All personnel involved in handling pharmaceutical products activities per station should be trained
on “IATA Introduction to Time and Temperature Pharmaceutical Products course“ (or equivalent))
within period of 12 months after the “Certification”
Assessment
Step 1
Training
Step 2
Validation
Step 3
Certification!!!
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Certification
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SATS Coolport Pilot Project
Handover ceremony in February 2014
2-8
Preparation 2 weeks Assessment Validation
weeks
Qualification Management
IATA conducts preliminary IVs are registered in IATA
interview with candidate to pre- database and available to
qualify candidate for training complete the assessments and
validations
IVs must undergo IATA training
and need to obtain the Diploma Coordination of IVs is
for Pharma Handling managed by the IATA
Consulting team for
IVs need to complete Diploma assessments and validations
within six months
IV cannot have been in a
IV’s can also become commercial relationship with
instructors but need to entity to be validated 12 months
undergo the IATA Train-the- prior to the engagement.
trainer course (optional)
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Recertification
Recertification will take place every two year – includes assessment and
one refresher training plus a validation if necessary
"CEIV Pharma
Certified"
Re-assessment
2 years 2 - 4 days
X Close gaps Validation
1 - 2 days
One Refresher
Training
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CEIV Pharma – Key Benefits
The CEIV Pharma is a win-win situation for the industry
Shippers Airlines, GHAs, Forwarders, Airports
Conduct simpler audits of operators Protect and grow revenues in fastest
Obtain guarantee that products would be growing segment of air cargo
handled in line with regulations Obtain recognition for operations, facilities
Experience lower rate of damage and loss and staff after meeting standards
due to temperature excursions Experience simpler audits from various
Be able to prepare their products ready for organizations
acceptance Promote their best practices to the shipper’s
community
Regulators IATA
Assured of safety of pharmaceutical Disseminated standards in the industry
products shipped by air Common audit criteria and global
Access structured and consistent training certification
and registry of independent validators and Promote air transport and so limit the modal
assessed operators shift
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Transforming Challenges into Success
The importance of partnerships
THANK YOU
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