This intensive 1 day course is intended to evaluate Good Distribution Practice (GDP) as required by Directive 2001/83/EC, Directive 2004/27/EC, EU Guidelines on Good Distribution of Medicinal Products for Human Use 94/C 63/03; it covers the new revised Guidelines, 2013/C 68/01 published on the 8th March 2013, and that are to be implemented within 6 months, by September 2013.
It offers a practical explanation of the guidelines for those who are active in the field of setting up and implementing GDP, as well as those involved in the management of quality systems for pharmaceutical products.
It reviews GMP/GDP supply chain integrity and examines the risk of counterfeit pharmaceutical products, a growing concern today. The course also reviews sample deficiencies found by regulators and how to improve compliance in these critical areas.
It offers a practical explanation of the guidelines for those who are active in the field of setting up and implementing GDP, as well as those involved in the management of quality systems for pharmaceutical products.
It reviews GMP/GDP supply chain integrity and examines the risk of counterfeit pharmaceutical products, a growing concern today. The course also reviews sample deficiencies found by regulators and how to improve compliance in these critical areas.