Export of Pharmaceuticals

A one-day course designed to increase understanding and educate on the approach to self-inspections/audits and the practical techniques needed to perform self-inspections/audits. The training is designed to help towards understanding the rules and regulations relating to Chapter 8 of the Good Distribution Practice Guidelines for Pharmaceuticals Distributors and Wholesalers. The training and exercises are designed to be engaging and provide an insightful look into the thought process of an auditor. The training is led by experienced former MHRA GDP Inspectors with years of experience conducting regulatory audits.

A course to enable the correct use of the Quality Risk Management in pharmaceutical distribution. The course follows the ICHQ9 model as recommended by EU GDP and MHRA to achieve a state of control. The approach is primarily proactive to ensure compliance but is also applied reactively on occasions.

A more detailed look at the regulatory changes required for the importation of medicinal products from ‘Countries on an Approved List’ and the role of the Responsible Person for Import (RPi). Topics covered will provide a more detailed insight into the activities associated with the role and the group work sessions help further clarify requirements and changes needed to introduce the RPi role into your business. Course will also look at the supply chain to Northern Ireland.

A one-day course guiding the UK WDA holder and Responsible Person through all aspects of temperature management through the pharmaceutical supply chain. Training is designed to help towards understanding the rules and regulations relating to Chapter 3 & 9 of the EU Good Distribution Practice Guidelines. Suitable for the Responsible Person, persons involved in Logistics and QA personnel involved in storage and distribution of Pharmaceuticals. The training and exercises are designed to be engaging and provide an insightful look into the thought process & requirements of maintaining the correct temperatures of pharmaceutical product to prevent the efficacy and quality being compromised.

A one-day course to develop knowledge and experience at a management level. The WDA Licence Holder is required to have a high level of knowledge to ensure obligations and regulatory requirements are met. Key obligations include outsourcing, provision of suitable equipment and facilities, providing adequate resources, provision of a Quality Management System and appointing a Responsible Person. The sessions and exercises are led by former MHRA Inspectors who offer a practical, pragmatic approach to training using real-world examples