Current occupation: Consultant on QA Validation projects at Abbott Laboratories BV, Zwolle, the Netherlands
CURRENT HOT TOPICS:
- PROCESS & CLEANING VALIDATION
- CONTINUED (ONGOING) PROCESS VERIFICATION
- PRODUCT QUALITY REVIEW (PQR) PROCESS OPTIMIZATION
- GAP ASSESSMENTS
- QMS REPORTS & QUERIES
SpeQ Reports is based in the eastern part of the Netherlands, founded by Drs. Ing. Michel Offringa in 2005.
As SpeQ Reports has over 20 years of GMP experience within the pharmaceutical industry, extensive knowledge is gathered related to several areas of expertise:
- GMP documentation, incl. templates and spreadsheets
- Quality Systems: QMS / DMS / ERP systems, e.g. TrackWise / Vault / Ennov / SAP
- Quality Assurance, e.g. Deviations / Changes
- Compliance
Reference standards provided by several international organizations are used, for instance EMEA, FDA, Ph. Eur., USP, ICH and ISPE.
Pharmaceutical companies can benefit from outsourcing projects related to all kinds of Good Manufacturing Practices (GMP) documentation.
In addition to the pharmaceutical industry also the Food, Veterinary and Chemical industry can benefit from SpeQ Reports.
The founder has studied various aspects of chemistry and has 5 years of experience within chemical research companies (analytical and organic chemistry related).
