TCL Controlling Your Pharmaceutical Products During Transport & Storge Guidlines

Temperature Controlled Logistics - Certified     - One day Training Course                                               Target Sectors: Pharmaceutical Manufacturers ( FDA & IMB Licenced Manufacturers) Export Service Providers Freight Forwarders, Distribution,Transportation, Air & Sea Cargo Warehousing & Storage Supported by the Irish Exporters Association  (Accel Funded) & Certified by the Institute of International Trade of Ireland (IITI), a division of the IEA and a  Fetac approved Training Body. Wednesday 31st October 2007 Bewleys Hotel Sandyford Dublin Tuesday 4th December 2007 Bewleys Hotel Sandyford Dublin Thursday 7th February 2008 Radisson Hotel Little Island Cork To book a place contact PharmaCareers at 01 2800437 or email info@pharmacareersireland.com Temperature Mapping We believe there is little understanding of the new temperature mapping requirements that the IMB now like to see when reviewing licence holders wither GDP or at GMP level. The IMB requirements in light of recent warmer summers have dictated higher standards and they have specified more detailed temperature mapping requirements and on-going temperature monitoring thereafter. It is essential that a company assess the warehouse in maintaining a defined temperature range specific to the product needs and monitor the worst –case locations identified by the temperature mapping studies. A protocol is required in advance of the study to state the key objectives of the study. In the course we will talk through in some detail Temperature mapping which would include showing participants a detailed sample mapping report and reviewing how this is carried out on the ground. It would also contain a review of the ‘hot & cold’ points and how these are used for ongoing temperature monitoring and a review of specific product temperature requirements. Temperature Monitoring In addition to the list of topics outlined below the course includes a review of current monitoring methods and review what is now available to increase standards in this area including the move towards RFID technology for monitoring temperatures. A review of records and actual temperature monitoring results would also be reviewed together with how excursions should be handled which is a very sensitive issues for many licence holders at IMB inspections We will review also what is available on the latest Root Qualification to provide assurance that product is delivered under the right conditions and within compliance. Discuss shipping studies and investigate current performance the actual supply chains. The IMB in 2006 have issued the new Guide: Guide to control and monitoring of storage and transportation temperature conditions for Medicinal Products and active substances. Other Topics  include: 1.     Basic Rules of Temperature Controlled Logistics 2.     Terminology 3.     Temperature Monitoring  Agreed Times Thermometer Placement Documentation 4.     Modal Application (Air, deep sea, trailer) Modal Selection 5.     Designated Responsibility Audits Quality Systems Team Training 6.     Equipment Calibration Cleaning 7.     Escalation 8.     Assessment/ Q & A Open book assessment within an allocated time frame Accredited by the Institute of International Trade of Ireland