Intermediate Good Distribution Practice (GDP) Intensive 3 Day Program - Certified Target Sectors: Pharmaceutical Manufacturers ( FDA & IMB Licenced Manufacturers) Export Service Providers Freight Forwarders, Distribution,Transportation, Air & Sea Cargo Warehousing & Storage Tuesday 6th Wednesday 7th and Thursday 8th November 2007 Radisson Little Island Cork Monday 14th Tuesday 15th Wednesday 16th January 2008 Radisson Hotel Little Island Cork  Tuesday 4th Wednesday 5th Thursday 6th March 2008 Bewleys Hotel Sandyford Dublin 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. To book a place telephone PharmaCareers on 01 2800437 or email info@pharmacareersireland.com Day 1 Introduction to GDP (click on link to see details of topics cover in day 1) Day 2 GDP & Temperature Controlled Logistics(click on link to see TCL topics) ReFacility/Warehouse Layout Rceipt, Storage & Distribution Inventory Management Deliveries to Customers Training & the role of people Role of the RP Traceability/ Bona Fides Day 3 Quality Systems Quality Systems - Personnel - Documentation Premises and Equipment -Deliveries to Customers -Returns Self Inspections –Traceability - Bona Fides Product specifications - Storage & Transportation Concept on managing the extended Supply Chain Key vulnerabilities of GDP What is expected from the Regulators- on the ground? Examples of what can go wrong when GDP best practice is not followed. The Role of the RP (Responsible Person). What the RP must do in practice to ensure compliance Day 3 Self Inspections & Standard Operating Procedures (SOPs) lThe aim and objective of inspections/audits lHow and who should carry these out. lHow often and what type of inspection/audits lHow do you know what areas need to be improved lWho should be involved lHow do you in practice carry out corrective and preventative actions (CAPA’s) lCritical GDP SOP’s required by the Regulators. lHow should they be operated in practice on the ground? lIdentifying what is required in writing SOP’s and ensuring these are maintained lDocumentation – essential standards required for GDP compliance lControlled forms lVersion control.