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 summer semester, the “Blue Belt Training”.
The main targets of the „Blue Belt Training“:
Dates:
18.06.2018 FDA WARNING LETTER ANALYSIS
25.06.2018 DRUG SAFETY OFFICER
02.07.2018 APPLIED GMP - CHANGE CONTROL
09.07.2018 APPLIED GMP - CAPA
16.07.2018 APPLIED GMP - QUALIFICATION
23.07.2018 SETUP OF QM SYSTEM: CASE STUDY
30.07.2018 ICH Q7 AUDITING GMP AREAS
06.08.2018 ADVANCED AUDITING - PSYCHOLOGY
27.08.2018 NEW ANNEX 15 - EU GMP GUIDELINE
03.09.2018 TOPIC CHOSEN BY THE AUDIENCE
10.09.2018 ADVANCED AUDIT SIMULATION
Duration: 06 p.m. – 07.30 p.m.
After successful participation, you will receive the certificate of
Blue Belt Training for Industrial Biotech Management
Duration: 06 p.m. – 07.30 p.m.
Location: Lecture Hall, Schlossplatz 4
Lecturer: Dr. Christian Grote-Westrick