Blood, Plasma and Stem Cells - Audits and Inspections - Live Online Training
5/6 November 2024
Course No. 20604
Speakers
Dr. Stephan Kiessig
PreviPharma Consulting
Dr. iur. Bita Bakhschai
Rechtsanwälte Scheller & Kollegen
Elke Weitershaus
Landesverwaltungsamt Sachsen-Anhalt
All times mentioned are CET.
Objectives
This Live Online Training 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.
Background
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.
Target Group
This Live Online Training is aimed at employees from blood and plasma suppliers, such as blood donor establishments, transfusion centres, fractionators etc. It is aimed at the same way to blood and plasma processing companies such as pharmaceutical manufacturer. Especially employees in manufacturing, quality assurance, quality control and analytics will benefit from this Course.
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
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Testimonials
Seminar Programme as PDF