New authors

Andreas Nuhn has been working as a freelance consultant since 2013. He uses his long years of experience in GMP compliance projects but also when preparing FDA audits and various training events. His areas of expertise include clean room planning and operation as well as the operation of isolators.

As a freelance GMP trainer, Christine Oechslein provides internal GMP training for pharmaceutical companies, manufacturers of active ingredients and suppliers. She has worked in the pharmaceutical industry for many years. As a speaker for different event organisers and an author, she shares her GMP knowledge in the areas of process validation, GMP training and GMP in development.

Silke Ohlendorf works in quality assurance at SK Pharma Logistics, where she is responsible for deviation, change and risk management. Other focal points of her work are the qualification of facilities and rooms as well as process validation in the logistics environment.

She also creates standard operating procedures and conducts employee trainings.

Jürgen Ortlepp is Head of QA, DACH (Germany, Austria and Switzerland) at Pierre Fabre Pharma GmbH in Freiburg since September 2023. During his career, he has acquired extensive expert knowledge in the areas of GMP and GDP. He is a lecturer at the Provadis School of Business and Technologies in Frankfurt and at the Fresenius University in Wiesbaden.

Dr. Sabine Paris is a senior GMP expert and was editor-in-chief of the GMP Compliance Adviser for GMP-Verlag Peither AG until 2024. In addition, she is responsible for the technical editing of the newsletter LOGFILE, reports from international conferences and is the technical contact for international external contacts and distribution partners. Besides that, she supports the publishing service "Toxicological Assessments".

After the foundation of the GMP publishing house in 1999, Thomas Peither was responsible for layout & production and supported the marketing. His main activity at that time was advising pharmaceutical clients as a GMP consultant (over 20 years). The changes of his activities in the last 20 years are considerable.

Christian Perlick is the head of GMP-Supply at Quasaar GmbH and is responsible for equipment qualification and the technical establishment of new analytical techniques. He has many years of practical experience in this field. Another focus of his work is software validation. Mr. Perlick is a member of the APV Task Force Data Integrity and has successfully participated in numerous audits and authority inspections (FDA).

As an independent consultant with experience in the pharmaceutical area for more than 30 years, Heinrich Prinz performs audits all over the world, runs national and international seminars, offers in-house training and supports companies to reach the regulatory compliance.

Petra Rempe works in the GMP/GDP inspectorate of the district government in Münster, Germany. After initially being responsible for the GMP supervision of manufacturing sites, her area of responsibility expanded with the increasing legal requirements and now also includes plants that have to work according to Good Distribution Practice (GDP) or the principles of good practice according to the EU Tissue Directive.

Bernd Renger has been working as a freelance consultant since 2011. He specialises in the development of efficient quality assurance systems, the preparation and follow-up of inspection, the establishment of effective deviation management and the design of sterile and aseptic processes.

Ulrike Reuter has been working for Sanofi-Aventis since 1989 in different technical positions. As an engineer in a pharmaceutical company, she strives to reconcile technical and GMP requirements. She is currently working on implementing the new Annex 15, Annex 11 and other technical GMP issues as part of operational support and project management.

Michael Rieth is a recognized expert in the field of microbiology and looks back on over 30 years of professional experience in the pharmaceutical industry. He gives presentations, provides training in his area of expertise and publishes in journals in books. Michael Rieth is involved in a number of expert associations and received the Wallhäußer award in 2013.

Rainer Röcker has been working in the pharmaceutical industry in different roles for more than 25 years. He was responsible for national and international facility construction qualification projects. He also works as a lecturer in the area of GMP, CSV, GDP, and calibration. Rainer Röcker is a GMP auditor and a recognised GAMP 5 expert.

Fritz Röder is a recognized expert in the field of water and ultrapure media technology. In addition to this specialisation he looks back on a wide range of of experience in the GMP environment. His various career stages enable him to a deep understanding of different points of view in the company.

Marta Rodríguez is a Biologist, Master’s Degree in Pharmaceutical Industry and Master’s Degree in Business Administration. She is passionate about science, health and technology, and throughout her professional career she has specialized in the pharmaceutical and life sciences industry.

Markus Roemer works as an independent consultant at comes compliance in Ravensburg. He is involved in a wide range of areas including the validation of computerised systems, auditing, quality management, project management and compliance management. Since 2008, he has been working as an ISPE ambassador for the DACH affiliate.

Andreas Rösch works as a project manager at Proleit AG since 2000. His emphasis lies on qualification of process control systems and implementation of the requirements of the EU and US authorities with regard to process control systems.

Markus Salemink has been working for Testo Industrial Services GmbH since 2008. After positions in the technical field service, sales and international, he is currently in charge of the Business Development Calibration division as division manager.

Christian Sander has been employed at Testo Industrial Services GmbH (TIS) since 2018. As head of metrology, he is responsible for the further development of calibration procedures and accreditation of new measurement quantities. He also coordinates the transfer of knowledge from the metrological institutes and scientific committees to the TIS laboratories.

Dennis Sandkühler is responsible for quality management at Digital Life Sciences GmbH. He is responsible for the introduction of GxP-relevant software solutions and computer system validation in customer projects. Previously, he worked in the development and regulatory affairs for medical devices. Dennis Sandkühler is a member of the ISPE D/A/CH and author of numerous technical publications.