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Updated in [September 26th, 2023]

What does this course tell?
(Please note that the following overview content is from the original platform)
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 scalequalification of large scale production to GMP compliance (vaccines)

We considered the value of this course from many aspects, and finally summarized it for you from two aspects: skills and knowledge, and the people who benefit from it:
(Please note that our content is optimized through artificial intelligence tools and carefully reviewed by our editorial staff.)
What skills and knowledge will you acquire during this course?During this course, participants will acquire the following skills and knowledge:
1. Understanding the process of gaining authorial permission to produce a vaccine: Participants will learn about the necessary steps and requirements to obtain approval from authorities such as the US FDA and local authorities in Europe. They will gain knowledge about the regulatory processes involved in getting authorization for vaccine production.
2. Establishing GMP compliance: Participants will learn about Good Manufacturing Practices (GMP) and how to ensure compliance with these standards in the production of vaccines. They will understand the importance of following GMP guidelines to ensure the safety, quality, and efficacy of the vaccines.
3. Inspection readiness: Participants will gain knowledge about the inspection process conducted by authorities to assess GMP compliance. They will learn about the specific aspects that are subject to inspection and the requirements that need to be met to receive a manufacturing license.
4. Qualification of large-scale production: Participants will learn about the qualification process for large-scale production of vaccines. They will understand the steps and criteria involved in scaling up production from pilot scale to large scale, ensuring that the production facility meets the necessary standards for manufacturing vaccines.
5. Understanding pharmaceutical approval in clinical trials: Participants will gain knowledge about the approval process for pharmaceuticals, specifically vaccines, in clinical trials. They will learn about the regulatory requirements and guidelines that need to be followed to conduct successful clinical trials and gain approval for the vaccine.

Who will benefit from this course?
Professionals in the pharmaceutical industry, specifically those involved in vaccine production, will benefit from this course. This includes researchers, scientists, quality assurance professionals, production managers, and regulatory affairs personnel. Additionally, individuals working in government regulatory agencies such as the US FDA and local authorities in Europe will also benefit from understanding the requirements for GMP compliance in vaccine production.

Course Syllabus

INTRODUCTION