GMP Compliance for Corona Vaccine Production
What you'll learn
- Manufacturing of Corona Vaccines and Compliance to Pharmaceutical Quality Standards
- No special knowledge required
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
Dr. Grote-Westrick studied biochemistry at Ruhr-University in Bochum followed by diploma thesis at Harvard Medical School, Boston, USA. After PhD Thesis at RUB and Yale School of Medicine Dr. Grote-Westrick started industry business at different biotech companies in various positions.
2000-2004 Biochemistry Studies (RUB, Harvard)
2004-2007 PhD in Biochemistry (RUB, Yale)
2007-2010 Manager in Biotech Company imusyn
2010-2013 Manager in Biotech Company BDL
since 2013 Head of QA at B.Braun
Pharmaceutical QA Head, RP GDP, GMP Trainer
Freelancing GMP Trainer at international graduate schools
Member of Directors Board at European GDP Association