Blood and Plasma - Audits and Inspections

This seminar will familiarize you with existing regulatory requirements for blood, blood products, plasma and blood products and will give you an overview of the latest changes. In addition, representatives from authorities, establishments, industry  and consultants will show you which requirements are placed on you and your quality management system during an audit or inspection and how you should prepare and follow- up an audit or inspection.

As a manufacturer or supplier of medicinal products or their starting materials, blood and plasma donation establishments as well as stem cell facilities are subject to drug approval and/or drug supervision. This means that the current rules and regulations regarding the collection, storage, transportation and processing of blood and plasma products should be familiar. In addition to the current legislation some national requirements (e.g. the German Guideline on haemotherapy), the Guideline on Plasma-derived Medicinal Products, or the guidelines of the medical associations in the member states should be taken into account. Especially for establishments and responsible persons located in the medical field, the pharmaceutical legal requirements and documentation requirements often present a new challenge.