Pre-Conference Training Days: Monday, September 26th – Tuesday, September 27th, 2011

SOLD OUT Good Transportation Practices for Air, Road and Ocean for Temperature-Sensitive Healthcare Products

Through interactive learning, case studies and student participation, this unique competency-based training course will provide participants with the tools upon which to increase understanding of end-to-end temperature assurance and the importance of individual practices within the supply chain. Learn the importance of SOP’s and Quality Agreements, trends in distribution and take part in practical demonstrations of packaging solutions and temperature monitoring. The course ends with a fun but serious review, assessment and certification of learning by taking part in the Cold Chain Game©.

September 26th (10.00am start) - September 27th (4.30 close)

Session 1

Session 2

Session 3

Welcome & Introduction Exercise

  • The evolving world of global healthcare logistics – terminology, trends & forecasts
  • The product development cycle
  • Trends in distribution – how does this impact logistics?

Real drugs for Real People

  • What is ‘temperature sensitive’?
  • Common temperature ranges

The regulatory environment

  • Review of global regulations
  • Overview of GXPs – focus on GDP
  • Responsibility in the supply chain – let’s map it out!

Good temperature management

  • Storage & Handling temperature Vs. Product temperature
  • Temperature deviations
  • Validation & Qualification explained
  • Temperature Mapping – facilities, transport vehicles; supply chains

PROTECT YOUR DRUG!

  • What you need to know about Active and Passive Packaging Systems
  • Choosing the right solution
  • Universal & Seasonal packaging configurations
  • Temperature Monitoring Devices - get set for your overnight exercise!
  • Data collection

Session 4

Session 5

Session 6

Session 7

Real drugs for Real People

Temperature Mapping - what we learned from yesterdays exercise.

Meeting cold chain requirements

  • Air cargo
    • Regulations
    • Packaging & labeling
    • Acceptance
    • Documentation
    • Ground handling
  • Road & Sea transportation
    • Best practice
    • Temp mapping
    • Qualification
    • Check-list

Real drugs for Real People

Quality Management

  • Purpose of a Quality Management System (QMS)
  • Implementation
  • Basic Audit Requirements; what do inspectors focus upon?
  • Risk assessment methodology
  • Training – creating a matrix

CAPA and its role in GDP

  • Case study and group exercise

SOP’s and Quality (Service) Agreements

  • The role of the SOP in logistics
    • Group exercise
    • What do I include?
    • How do I write it?
  • SOP’s & temperature excursions
    • The role of the Quality (service) agreement
    • Responsibilities
    • Contingency plans
    • Monitoring suppliers
    • KPI’s
    • Improving performance

Recap

Course Review and Assessment ‘The Cold Chain Game’©

Course Benefits: By the end of the 2-day course participants will have gained a detailed understanding of:

  • The world of healthcare logistics and the increasing pressures of globalization
  • The various and varied roles with the logistics supply chain
  • The regulatory environment for Good Distribution Practices
  • Good temperature management
  • Passive and Active packaging solutions
  • Quality management in logistics
  • Best practices in land, sea and air distribution
  • Service Level Agreements and SOP’s
  • Improving supplier performance
  • Audit requirements

Target Audience: This course will be of benefit to all those involved in the Healthcare Cold Chain process, in particular

  • Logistics service providers
  • Healthcare product manufacturers
  • Wholesale distributors
  • Cargo ground handling companies
  • Quality Organizations
  • Freight forwarding companies
  • Transportation providers – land, air and ocean
  • Packaging solution providers
  • Regulatory Authorities

Trainers

Good Transportation Practices for Air, Road and Ocean for Temperature-Sensitive Healthcare Products - a 2 day Training Course

1

Tony Wright, Managing Director of Exelsius Cold Chain Management has many years’ experience of the distribution and temperature-controlled air cargo sector, having worked as a Senior Executive with British Airways World Cargo and subsequently as Senior Vice President at Swedish cold-chain container company, Envirotainer. His experiences in these sectors lead Tony to form Exelsius in 2007as an independent cool chain management consultancy. Since then the company has progressively developed into a foremost provider of independent leadership, consulting, research and training services to manufacturers, airlines, forwarders and handling companies in the life science logistics sector. With its unique cross-sector knowledge of the industry, Exelsius has been consulted on a diverse range of projects around the world and has been a driving force behind the development of the IATA Chapter 17 Regulations for Time and Temperature-Sensitive Healthcare Products, having co-authored the publication and chair of the working group that created the Time & Temperature-Sensitive air cargo label. Having successfully developed and delivered the first ‘Chapter 17’ training course, Exelsius has gone to create in-house training programs for several companies based upon a matrix approach to Good Distribution Practice requirements. Tony is a member of the Parenteral Drug Association (PDA) and serves on its European Cold Chain Interest Group as well as being an elected member of the IATA ‘Time and Temperature Task Force’.

Kevin O’Donnell is Senior Partner at Exelsius Cold Chain Management - US an international provider of consulting, research and training services to manufacturers, airlines, forwarders and other stakeholders in the life science logistics sector. With its unique cross-sector knowledge of the industry, Exelsius has been consulted on a diverse range of projects around the world including in-house and public training, logistics product development, Quality Management System introduction and facility design.

Mr. O’Donnell’s contributions to industry are widely recognized. He is internationally respected as an advocate, author, blogger, educator, training developer, and champion of good distribution and logistics practices for temperature-sensitive drugs. His involvement with industry spans such organizations as the International Air Transport Association, where he serves at Chair of the Time & Temperature Task Force; the World Health Organization, as a temporary advisor; the United States Pharmacopeia, as a member of the 2010-2015 Expert Committee on Packaging; and the Parenteral Drug Association, as a founding member of the PCCIG, co-author of Technical Report #39, and training co-developer.

Prior to joining Exelsius, Mr. O'Donnell was Director and Chief Technical Advisor to Industry at ThermoSafe Brands. He retired in 2005 as a Principle Packaging Engineer after a 26-year career at Abbott Laboratories.

 

Pharma IQ

Become a Pharma IQ Member and receive our weekly newsletter!

Connect to a global Pharma IQ social network

  • Linkedin

    Linkedin

  • Twitter

    Twitter

  • Facebook

    Facebook

Early Bird Discount

Early Bird Discount

Special Offer!
Register by July 22 to receive discounts of up to $2,603!

Early Bird Discount

Mark Your Calendar

Reminder for this event

Early Bird Discount

Tell a colleague

Tell a Colleague

Media Partners

_media

Sponsorships and Exhibits are excellent opportunities for you to showcase your latest product/service.

For Sponsorship Opportunities please contact Andrew Heholt at Andrew.heholt@iqpc.com

Event Bag Sponsor

BA-World-Cargo

UPS – Main Cocktail Reception Sponsor

UPS