The requirements in pharmaceutical distribution are constantly increasing for all partners involved. The seminar provides practical recommendations on how to meet the challenges that arise in an inspection-safe manner.
Background
The GDP Guideline of the European Commission was published to ensure the quality and integrity of medicinal products throughout the supply chain. The Good Distribution Practices apply to manufacturers, wholesalers and all other service providers involved in the distribution of medicinal products. They are also intended to prevent counterfeit medicines from entering legal supply chains.
To ensure this, the parties involved must establish a quality assurance system which, in addition to the typical requirements (risk management, training, qualification of equipment, etc.), also ensures complete documentation of all relevant information on the origin and whereabouts of the medicinal products. In addition, the systematic handling of complaints, returns, suspected cases of counterfeiting and drug recalls must be set out.
The speaker
Tim Ohlrich studied biotechnology at the Berlin University of Applied Sciences before working as a graduate engineer in development and production at various life sciences companies. He has been with gempex for about 15 years and is now responsible for the company's project area as GMP Compliance Manager. His core competencies lie in the development of overall concepts for GMP and GDP as well as the development and introduction of quality management systems.
The event
As a GDP expert, Tim Ohlrich will support the seminar on s with his know-how on the topic of "Qualification of service providers in transport" as well as in an interactive workshop in which examples from transport validation in air freight will be presented and discussed. In his lecture, he will present options for qualifying transport service providers and provide an overview of the entire distribution chain, known as "quality oversight".
The benefits
On the one hand, participants will meet speakers who will explain their experience and knowledge using practical examples, and on the other hand, representatives of the authorities who have to experience and evaluate the implementation in inspections. An extremely interesting forum for questions and answers.
The gempex team of experts will be happy to answer your questions on this topic via contact@gempex.com.