INDUSTRIAL PHARMA MANAGEMENT - from Concept to Market
In this lecture, general tasks and responsibilities of a project manager in biotech industries will be illustrated. The participants will receive information on important aspects of GMP-conform pharmaceutical production, risk management in biotech industries, and modern management strategies.
The lecturer has developed a two stage concept for teaching GMP. The first part, had included basic principles, qualification and validation, and risk management. The successful completion of this “White Belt Training” would be helpful but is not a prerequisite to participate in the second part, to be offered in this winter semester, the “Blue Belt Training”.
The main targets of the „Blue Belt Training“:
Dates:
05.10.2020 FDA WARNING LETTER ANALYSIS
12.10.2020 PHARMACOVIGILANCE
19.10.2020 APPLIED GMP - CHANGE CONTROL
26.10.2020 APPLIED GMP - CAPA
02.11.2020 APPLIED GMP - QUALIFICATION
09.11.2020 SETUP OF QM SYSTEM: CASE STUDY
16.11.2020 IMPs - INVESTIGATIONAL MEDICINAL PRODUCTS
23.11.2020 ADVANCED AUDITING - PSYCHOLOGY
30.11.2020 NEW ANNEX 15 - EU GMP GUIDELINE
07.12.2020 TOPIC CHOSEN BY THE AUDIENCE
14.12.2020 ADVANCED AUDIT SIMULATION (FDA FINDINGS)
Duration: 06 p.m. – 07.30 p.m.
After successful participation, you will receive the certificate of
White Belt Training for Industrial Biotech Management
Duration: 06 p.m. – 07.30 p.m.
Location: Zoom Lecture
Lecturer: Dr. Christian Grote-Westrick