Biotech Quality Manager / Regulatory Affairs Manager – Job Insights and Training

Technical University München

Quality Management becomes obligatory for companies producing medical products such as drugs and diagnostics. Especially
international business and approval requires certified quality management systems thus new quality managers have quite attractive job prospects these days.
For reproducible processing in biotech manufacturing and also total traceability at all stages of production quality managers in biotech industry face several important tasks
and challenges. 

This workshop illustrates the job of quality managers in biotech companies dealing with general regulating documents
(ISO 9001), medical products (ISO 13485), analytical and calibrating services (ISO
17025) and US market approvals (510(k) procedure). Within this workshop participants will construct an own quality management system for their own fictional company with
different product focus.


Workshop directory:
1. Introduction into quality management

2. Setup of quality management handbooks

3. How to certify quality managements

4. Case studies: quality managements of biotech companies

5. Approval of medical products based on QM systems (European Union, United States of America, Asian Markets)

6. Interaction (setup of quality management for own company)
3 groups:
Company 1: QM system compliant to ISO 9001
Company 2: QM system compliant to ISO 13485
Company 3: QM system compliant to ISO 17025

7. Job Preview: Quality Manager (Tasks and Goals)

More Information
Flyer and Programme
More about Grote-Westrick.com
Publication

Registration: gzw.trainings@wzw.tum.de
Registration Deadline: 20.10.2017
The course is free of cost.

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