• Pharmaceutical Quality Systems

    We are specialized in assisting clients by providing expertise, on site support and on site training courses covering implementation and optimization of Pharmaceutical Quality Systems according to FDA, EU GMP, ICH and PIC/S. Implementation of ICH Q10 throughout the product lifecycle should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.
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  • Change Management - Establish and Maintain a State of Control

    Innovation, continual improvement, the outputs of process performance and product quality monitoring and CAPA drive change. In order to evaluate, approve and implement these changes properly, a company should have an effective change management system. The change management system ensures continual improvement is undertaken in a timely and effective manner. It should provide a high degree of assurance there are no unintended consequences of the change.
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  • Enablers: Knowledge Management and Quality Risk Management

    Quality risk management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle. Quality risk management can be useful in identifying the monitoring and control systems.
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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 (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




Dr. Bernd Renger has more than 42 years industry experience in different managing positions in API Manufacturing and Pharmaceutical Industry. He started his professional career with Hoechst AG as a Research and Development Chemist.

Since then, he has held positions as Director of Quality Control and/or Quality Assurance at Mundipharma (Limburg), Byk Gulden/Altana Pharma (Singen), Baxter BioScience (Vienna) and Vetter Pharma Fertigung (Ravensburg).

He holds a degree in Organic Chemistry from the University in Giessen, Germany and is an appointed Qualified Person according to the European regulations and has acted as a Qualified Person in the EU for more than 34 years. He is an expert in Quality Systems and Quality Risk Management System design, development and implementation.


 Dr. Bernd Renger


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Dr. Bernd Renger


Bernd Renger has been Member of:

  • The Expert Group "Pharmaceutical Analysis/Quality Control" of the German Pharmaceutical Society
  • The Advisory Board of the European Compliance Academy (ECA)
  • The Advisory Board and Chairman of the European Qualified Person (QP) Association;  www.qp-association.eu (external link) 

He is author or co-author of more than 80 publications and is a frequently invited speaker by organizations such as PDA, Advanstar, IBC, IIR, Forum, PCS,  European Compliance Academy and Concept Heidelberg at more than 150 events or training courses covering:

  • Synthetic organic chemistry
  • Pharmaceutical analysis & analytical uncertainty
  • Qualification and validation
  • Measurement uncertainty and specification limits
  • Benchmarking and efficacy of quality operations
  • FDA compliance
  • Handling of OOS results and failure investigations
  • Quality Systems
  • Role and responsibilities of the Qualified Person




  • 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


  • L. Kaminski, M. Degenhardt, J. Ermer, C. Feussner, H. Höwer-Fritzen, P. Link, B. Renger, M. Tegtmeier, H. Wätzig; Efficient and economic HPLC performance qualification; J Pharm Biomed Anal. 2010 51(3) 557 - 564
  • E. Podpetschnig-Fopp, B. Renger, EMEA Reflection Paper on a Proposed Solution for Dealing with Minor Deviations from the Detail described in the Marketing Authorisation for Human and Veterinary Medicinal Products; Pharm. Ind. (2009) 71 (5): 844 – 851
  • B. Renger.; The "Qualified Person" according to Directive 2001/83 - GMP Manual, Update 07, Kapitel 19.B (2010), Maas & Peither AG – GMP Publishing
  • B. Renger: GMP Logfile 29/12: Korrektur- und Vorbeugemaßnahmen (CAPA) - GMP Berater - August 2012 - Read online
  • K. Ferenczi-Fodor, B. Renger, and Zoltán Végh, The Frustrated Reviewer – Recurrent Failures in Manuscripts Describing Validation of Quantitative TLC/HPTLC Procedures for Analysis of Pharmaceuticals; Journal of Planar Chromatography 23 (2010) 3, 173–179
  • B. Renger , QPSHARE: a new way to share audits - Pharmaceutical Technology Europe, 22 (6), (2010) - Read online
  • E. Anhalt, C. Edelmann, C. Langer, E. Podpetschnig-Fopp, B. Renger, M. Sieling, M. Veit, R. Völler, White Paper der Forschungsvereinigung der Arzneimittel-Hersteller zur Kommentierung des EG-GMP-Leitfadens Kap. 1.4
  • B. Renger, Rolle der sachkundigen Person in pharmazeutischen Qualitätssystemen, Pharm. Ind. (2010) 72 (7): 1160 - 1165 ; 72 (8): 1346 – 1353
  • B. Renger , O. Schmidt; The Role of the Qualified Person in European Pharmaceutical Regulations; Pharmaceutical Technology North America (online), 34 (10): (2010) - Read online
  • B. Renger; Präzision - Abweichungen und OOS („Out of Specification")–Ergebnisse in der pharmazeutischen Analytik; quantos Journal 01/10, 2 – 7 (2010)
  • B. Renger, Z. Végh, K. Ferenczi-Fodor; Validation of thin layer and high performance thin layer chromatographic methods; Journal of Chromatography A, 1218 (2011) 2712–2721
  • K. Ferenczi-Fodor, Z. Végh, B. Renger; Impurity profiling of pharmaceuticals by thin-layer chromatography; Journal of Chromatography A, 1218 (2011) 2722–2731
  • B. Renger - GMP Logfile Nr. 18 - Mai 2013 (online and print) - Read online (German version only)
  • O. Lopez (B. Renger, M. Roemer) - EU Annex 11 Guide to Computer Validation Compliance - CRC Press – 368 Pages – 22 B/W Illustrations; ISBN 9781482243628 - Read more


Contact details

Dr. Bernd Renger

Bernd Renger Consulting

Moegginger Steig 28

78315 Radolfzell


email: bernd.renger(at)br-consult.eu

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