We are specialized in assisting clients by providing expertise, on site support and on site training courses covering implementation and optimization of Quality Systems according to FDA, EU GMP and PIC/S with emphasis on:
- Risk management & risk-based GMP interpretation
- Inspection Preparation (US-FDA, National Authorities)
- Batch Release and QP Services
- CAPA and Deviation / Complaint Handling
- Supplier Quality Assessment and Auditing
- Operational Excellence
- Laboratory & Analytical Operations including OOS (Out of Specification) Result Handling
Bernd Renger has scientific education as a synthetic organic chemist and holds a Ph.D. from Justus-von-Liebig University, Giessen.
He has over 45 years of professional experience and expertise in Pharmaceutical R&D, API production, Pharmaceutical Analytics, Quality Control, Quality Assurance and has considerable management experience in running complex Quality Organisations of global companies including Hoechst AG, Mundipharma, Byk Gulden/Altana, Baxter BioScience, and Vetter Pharma.
Bernd Renger has been member of several expert groups of the German Pharmaceutical Society and European Compliance Academy (ECA) and of the Advisory Board of the European Compliance Academy (ECA).
He was a co-founder and member of the Advisory Board and first Chairman of the European Qualified Person (QP) Association.
Bernd Renger is author or co-author of more than 80 publications, and a frequently invited speaker for various reputable conference and training providers, having given presentations at more than 200 events or training courses, covering:
- Synthetic organic chemistry
- Pharmaceutical analysis & analytical uncertainty & specification limits
- Qualification and validation
- Benchmarking and efficacy of quality operations
- Regulatory and FDA compliance
- Handling of OOS results and failure investigations
- Quality Systems
Services:
- Risk Management & risk-based GMP interpretation
- CAPA and Deviation/Complaint Handling
- Batch Release and QP Services
- Laboratory & Analytical Operations including OOS (Out of Specification) Result Handling
- Supplier Quality Assessment and Auditing (Finished Product, API, Excipient and Packaging Material Suppliers, Contract Facilities, Warehouses and Testing Sites)
- Operational Excellence
- Inspection Preparation (FDA, National Authorities)
- Electronic Batch Recording
- Data Integrity Assessments
- Validation and Qualification Services
- Document Management Systems
- In-house Trainings and Work Shops
- Professional Project Management
