The FHS Team

Fritz Speck

Fritz Speck has worked in the pharmaceutical industry for more than 40 years. After completing his apprenticeship and engineering degree, he worked for various pharmaceutical companies in the fields of R&D, clinical trial products, production and marketing & sales.

 

In 2011, he founded FHS Unternehmensberatung. Currently his focus areas are:

 

  • Implementation and maintenance of pharmaceutical quality management systems (QMS)
  • IT and computer validation (CSV) in the fields of GMP
  • Data Integrity and compliance with cGMP regulations
  • Supplier management

Britta Pöschl

Britta Pöschl has worked in various positions and as a Senior GMP Consultant for manufacturers of pharmaceuticals and medical devices. Since 2017, she is member of the FHS-Team.

 

She has a special expertise in quality management. Currently her focus areas are:

 

  • Preparing and monitoring of QM systems according to GMP and ISO 13485
  • Process validation and qualification of equipment according to GMP
  • Maintenance and calibration
  • Execution of internal audits and support during approval inspections by authorities

Lisa Landsteiner

Lisa Landsteiner has supported our team as a Junior GMP Consultant since 2019. The certified computer validation representative has most recently worked for several years in the field of quality assurance for a research-oriented biotech company.

 

Currently her focus areas are:

 

  • Qualification and validation of computerized systems (CSV) in the Pharma Industry
  • Quality management and Periodic Quality Review (PQR)
  • Introduction and maintenance of QM systems according to GMP and ISO 9001
  • Supplier management