Fritz Röder

Fritz Röder was both in plant engineering and construction and on the side of the procurer and the operator and is therefore aware of the difficulties involved in procuring of plants. He also has expertise in solid, semi-solid and liquid (sterile) pharmaceutical forms. In the last years he was involved in various audits and inspections.

Fritz Röder worked in plant construction and on the side of the pharmaceutical company as procurer, operator, project manager, troubleshooter and in quality assurance and can therefore illuminate GMP situations from all sides. Also he has expertise in solid, semi-solid and liquid (sterile) pharmaceutical forms. In recent years he has been involved in various audits and inspections.

After a first activity in plant engineering for ultrapure water technology he was both as the responsible operator and as the procurer for all media systems employed by a pharmaceutical company for solid forms. The next station led Fritz Röder to Bayer AG Grenzach, where he managed several major projects concerning semi-solid and liquid sterile pharmaceutical forms and was involved in a major FDA inspection. From 2015 to 2017, he was Project manager employed by Allergan plc.

Since June 2017 he has been working as Senior Manager Validation, Qualification & Engineering at Merck KGaA in Darmstadt and is driving site-wide projects there, among other things on data integrity and FDA readiness.

Fritz Röder is also a member of the EDQM working group for water, the ISPE Steering Committee "Water and Steam" and the Parental Drug Association.

He is author or co-author of the following chapters of GMP Compliance Adviser:

• 5.A Water qualities
• 5.B Pharmaceutical Water Generation
• 5.D Qualification of water supply systems