New authors

From 2015 to 2019, Paulino Alonso worked as toxicologist and GMP cosultant at Azierta. He led more than 50 projects of implementation of ICH Q3D. He was responsible for internal training, revision, customer service and development of tailor-made implementation strategies.

Thomas Altmann is Principal Global Technical Consultant for the Ecolab Life Sciences Division. He has more than 24 years of professional experience as a technical consultant in cleaning, cleaning validation and hygiene concepts of product-contacting surfaces in the pharmaceutical and biotechnological industry, cosmetics industry and API production.

Mr. Arslan completed his training as a mechatronics technician (automation technology) at Merck KGaA in Darmstadt from 2010-2013. After completing his training, he continued to work there as a mechatronics technician for a maintenance team in the solids production. During this time, he also successfully completed his further training as an industrial foreman in electrical engineering in 2015.

Authors from A to Z: Find an alphabetical list of our authors in the GMP Compliance Adviser. Click here!

Herbert Bendlin is a recognised expert in the field of pharmaceutical water. As a freelance consultant, he provides services, consultancy and training in this area. He also works as an expert, author and speaker.

Stephanie Blum is the owner and CEO of the cirQum consultancy in Frankfurt which she founded in 2008. The molecular biologist had previously worked in the biotechnological and pharmaceutical industry at managerial level for 10 years.

Cornelia Bodinet specialises in medicinal plants and their microbiological and pharmaceutical quality requirements. She is also an expert in pharmaceutical analysis, pharmacology and toxicology, quality control, quality assurance and sanitation.

Doris Borchert is a senior GMP expert and editor-in-chief of GMP BERATER for GMP-Verlag Peither AG. In addition, she is responsible for further publishing products, for example the technical editing of the german SOP for the pharmaceutical industry and she supports the development of new publishing products and is the technical contact for "Ask our Experts".

Frank Böttcher is a pharmacist who has specialised in pharmaceutical analysis. He looks back on a long career as a qualified person and in the management in various companies of the pharmaceutical industry. Since 2021 he is working as Managing Director and Qualified Person at HWI pharma services GmbH.

Ruven Brandes became Head of Technology and Compliance Support for technical QA in 2006. He combines technological expertise with a strong quality awareness and possesses a broad range of professional experience. Ruven Brandes is involved in a number of different associations and committees and also works as an author and speaker.

Melanie Braun works at Labor LS SE & Co. KG in the Microbiological Services section and is responsible for industrial hygiene, microbial identification, the maintenance of reference strains, and culture media. She also conducts training seminars and offers customers individual practical training courses.

Raimund Brett is a Principal Consultant at gempex GmbH.

Graduate engineer (UAS) Christoph Brewi is the team leader responsible for the GxP compliance department at CLS Ingenieur GmbH. He and his team support various clients with specialised, high-quality GxP services.

Ana María Castro was GxP Compliance & Safety Manager at Azierta. Her role was to support the clients in the risk evaluation of their products and processes as well as in their approaches for the safety improvement and compliance.

As a Principal Consultant at PAREXEL, Michael Craig helps clients prepare their CTA, marketing authorisation and variation submissions as a CMC Subject Matter Expert and provides regulatory and technical input for lifecycle activities in European and international markets.

André Deister has been employed by Sanofi - Aventis Deutschland GmbH as Head of OC Packaging Material since the beginning of 2015. In the meantime, he has assumed overall responsibility for packaging material control, which also includes secondary packaging materials, processing aids and single-use systems. He has many years of experience in the testing and release of pharmaceutical packaging materials and has carried out many supplier audits at manufacturers of packaging materials.

Richard Denk has been working in the areas of hygienic design, containment and the production of highly active substances for over 20 years. He has been head of the containment group for the production of highly active substances since 2014. He developed the Containment Pyramid and founded the Containment Expert Group of the ISPE DACH. Furthermore he was the initiator and responsible for the ISPE Containment Handbook published in 2015.

Xenia Dimont works as a GMP/GDP inspector for the government of Upper Bavaria.

Hannes Dittinger worked for many years as a chemical engineer in research and production before specializing in the field of computerized systems. Today, he is a Computerized Systems Representative and deals, among other things, with the qualification of computerized systems.