New authors

Torsten Knöpke is responsible for the newly established LifeSciences division at Ecolab Deutschland GmbH since 2016. LifeSciences focuses on hygiene concepts and solutions in the pharmaceutical industry in the area of cleaning and disinfection as well as cleaning technology and validation of processes.

Annette Könemann has been Head of Quality at Labor LS SE & Co. KG since 1994. In July 2019, she was appointed authorized signatory and has been representing the department "Integrated Management System" since then in the management. She is technically responsible for ensuring compliance with national and international regulations in the testing of pharmaceuticals and medical devices.

Markus Kopf has been employed at Testo Industrial Services since 2012. As division manager he is responsible for about 50 employees of the GxP Service. These calibrate, qualify and validate throughout Germany for customers from the pharmaceutical, medical technology and life sciences sectors.

Nicole Kordek has many years of experience in the areas of Quality Control, Quality Assurance and Regulatory Affairs. Since June 2020 she has been working for Wessling GmbH, Münster as Qualified Person and Regulatory Affairs Manager.

As a senior operations manager, Frank Kugler is responsible for Microbiological Services at Labor LS SE & Co. KG. He also works as a trainer and is a safety expert. An expert in industrial hygiene, he advises customers when issues arise in this area.

From 2007 until his early retirement in 2018, Josef Künzle worked for Basilea and has been Head of Global Quality Management with responsibility for all GxP areas since 2013. He had previously worked in the pharmaceutical industry for 18 years in the areas of analytical R&D, quality control and quality management. He has taken part in official inspections and global supplier audits.

Max Lazar looks back on an outstanding career within the pharmaceutical industry. For more than 35 years he was working with Hoffmann-La Roche. Following his retirement, he established a consulting business specializing in API GMP issues and the training of personnel covering the ICH Q7 Guidance. His more than 40-year career in the pharmaceutical industry includes numerous memberships in professional organisations and chairs of committees.

Markus Limberger is co-founder of the QUASAAR GmbH which has been providing GMP consultancy in product development and product control to the pharmaceutical and life sciences industries since 2015. His areas of expertise include method transfer, OOX process, qualification of standard substances and reagents, auditing and increased efficiency in the laboratory.

After graduating in Law, Volker Lücker worked as a researcher in the Department of Criminal and Medical Law at the university.

in memoriam

Wolfgang Mahl was self-employed since 1980 in the field of clean room, air conditioning and laboratory technology. Since 2008 he worked as an external consultant for planning, consulting and delivery of cleanroom components. In addition, he was involved in standards committees and working groups.

Since 2019, Martin Mayer is Vice President and Head of the Manufacturing Quality Assurance Competence Center with global responsibility for production-related quality assurance issues. These include quality risk management, root cause failure investigation, technical compliance, visual inspection, container closure integrity, process control strategies, process validation and many more.

Heike Meichsner is is a Qualified Person and leads the QA Pharmaceutical Projects team together with Susanne Schweizer in job sharing.
She looks back on many years of professional experience with a focus on consulting in quality management, product and process development as well as stability management and quality systems.

Sabine Mendel has been working as Packaging & Artworks Senior Specialist for Wörwag Pharma GmbH & Co. KG since July 2016. Her main task is the coordination of the entire go-to-market process of printed secondary and primary packaging materials, as well as artwork creation/modification.

Thomas Moest has been working as a consultant for GMP, GDP and patent-related issues since 2010. He previously worked in the pharmaceutical industry for many years and held managerial positions in different departments (Galenics, Quality Control, Quality Assurance). Thomas Moest is the owner and co-owner of many patents.

Dr. Olaf Mundszinger is the founder of A&O Pharma GmbH, which since 2019 (initially as A&O Pharmadienstleistungen) has been offering consulting services for the pharmaceutical sector as well as releases of medicinal products and clinical investigational medicinal products. His main focus is the monitoring of GMP-compliant manufacturing and batch release of clinical investigational medicinal products.

Dr. Wolfgang Nedvidek has been working as an independent consultant since 2009 and deals with the practical implementation of GMP requirements. He conducts trainings for employees in the GMP environment and is also active as a speaker. His main topics are documentation, quality management and quality control.

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 has been Division Manager at Infraserv Logistics GmbH since 2009. During his career, he has acquired extensive expert knowledge in the area of quality management. He is a lecturer at the Provadis School of Business and Technologies in Frankfurt and at the Fresenius University in Idstein for QM/GMP and Logistics.