MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 820 MB | Duration: 1h 14m
What you'll learn
Manufacturing of Corona Vaccines and Compliance to Pharmaceutical Quality Standards
Requirements
No special knowledge required
Description
Recently BioNTech has acquired Novartis plant in Marburg for large scale manufacturing of Corona vaccines. This current approach represents innovative but also risky procedure since vaccine candidate must be approved and production line must be inspected by authorities (US FDA, local authorities in Europe)
In order to receive authorial permission to produce this vaccine, several things must be performed to establish GMP compliance. These aspects are then subject of authorial inspection representing prerequisite for receiving manufacturing License.
In this seminar you will learn all relevant issues to qualify a production plant for pharmaceuticals based on this prominent case study for large scale mRNA vaccine manufacturing. This theoretical approach will illustrate authorial requirements for pharma production and general drug approval.
Teaching goals [printed on certificate]:
approval of pharmaceuticals (vaccines) in clinical trials
from pilot scale to large scale
qualification of large scale production to GMP compliance (vaccines)
Who this course is for:
Life Science Students, Quality Managers in Pharmaceutical Industry
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Cantinho Satkeys
