Advanced 2 Day GDP

Good Distribution Practice (GDP) & Temperature Controlled Logistics (TCL)

Course Outline

This course offers a practical explanation of the current guidelines for those who are active in the field of setting up and/or implementing GDP, as well as the management of quality systems and the supply chain for Pharmaceutical & Medical Device products. The training workshop is highly interactive and is aimed at individuals who wish to increase their knowledge and understanding of the current requirements of GDP.

Two 2 Day Intensive Workshop

2012 Dates: September 10th & 11th.

Training Objective

This two day training course aims to offer participants a comprehensive understanding of Good Distribution Practice (GDP) & Temperature Controlled Logistics (TCL) in relation to the guidelines and directives of the Irish Regulatory Authority (Irish Medicines Board-IMB) and other International Regulatory Authorities including EMEA & FDA.

Understand the regulatory requirements and constraints facing manufacturers in the management of the supply chain from sourcing to final distribution (Bona fides of suppliers and customers).
Become familiar with EU 94C 63/03 Guidelines and the Irish Medicines Board (IMB) Guidelines on GDP and the expectations of the regulator.
Identify the controls necessary to ensure compliance with GDP along the supply chain including all facilities used
Latest expectations on Temperature Controlled Logistics, including a review of Temperature Management requirements across the supply chain.

Target Sector

Pharmaceutical Manufacturers
Medical Device/Diagnostic Manufacturers
Supply Chain Service Providers
Distribution and Wholesale Companies

Target Audience

Manufacturing Quality Personnel overseeing Compliance in Warehousing, Distribution & Transportation Activities
Warehouse and Distribution Supervisory and Management Staff
Quality Assurance personnel engaged in Auditing & Inspecting Logistics Service Providers
Corporate Quality & Logistics Executives with input into overseeing Supply Chain Quality Compliance.

Course Format

The course consists of formal content presentation interspersed with content quiz sessions. The presenter’s style involves intensive audience participation.

Course Design & Accreditation

Certificate of Completion accredited by Institute of International Trade of Ireland (IITI) the Research & Training Body of the Irish Exporters Association – IEA (a Fetac approved training body). The Course was designed in consultation with IMB and inline with GDP Manufacturers Code of Practice (IEA).

Booking

For further information or to book a place please contact us.