New authors


Susanne Schweizer is a Qualified Person and leads the QA Pharmaceutical Projects team together with Heike Meichsner. Among other things, she is responsible for the coordination of pharmaceutical projects of Dr. Falk Pharma and the GMP system to ensure regulatory compliance. The focal points of her long professional career include quality management, training, complaints processing and stability management.


Silke Schwiertz has been Head of Quality Management and Assurance since 2010 and is responsible for the QM system of Medice and its subsidiaries. She is also the Quality Management Officer for senior management and a Qualified Person.


Hanfried Seyfarth is a renowned expert in the field of microbiology. During his career, he held different positions, including Head of the Laboratory for Microbiological Quality Control, Head of QC and Head of Microbiology.


Nicola Spiggelkötter has been a freelance consultant since 2009. She provides consultancy for companies in the areas of pharmaceutical logistics, transport service providers, strategy consultancy, validation and qualification based on many years of experience in the pharmaceutical industry. Her other areas of expertise are cold chain and process optimisation.


Anton Steurer is responsible for the validation of ventilation systems, clean rooms, building technology systems, temperature-controlled objects and transport validation.


Olaf Stoll has many years of professional experience in the area of heating, ventilation and air-conditioning. For the past 25 years, he has worked primarily in the pharmaceutical and cleanroom technology sectors. He has taken part in a number of different audits and frequently performs Quality Assurance assignments for various projects.


Thomas Trantow provides in-house training and consulting in almost all areas of pharmaceutical quality control. He is currently working on trend analyses, evaluation of stability studies, analytical method validation and Excel in GMP applications (data integrity in Excel applications).


Mark Tucker is the Founder and President of Mark Tucker, LLC, a consulting firm specializing in Inspection Management and GMP training. Mark has over 15 years experience in the area of Pharmaceuticals, including experience at FDA as an Investigator, Analyst, Compliance Officer and finally Investigations Branch Director.


Barbara Unger formed Unger Consulting, Inc. to provide GMP auditing and regulatory intelligence services to the pharmaceutical industry, including general GMP auditing and auditing and remediation in the area of data management and data integrity.


Professor Markus Veit is the Managing Director of ALPHATOPICS GmbH in Kaufering, Bavaria. He is also a member of the Committee for Pharmaceutical Chemistry of the German Pharmacopoeia. In his academic teaching activities he holds lectures at the universities of Frankfurt and Berlin.


After graduating in Mechanical Engineering with a focus on fluid mechanics, Thomas von Kahlden became a researcher at the Fraunhofer Institute in the area of clean room technology. He founded his own company in 1996 which develops and produces measurement and testing equipment for clean room technology and carries out all types of clean room-related measurements and qualifications.


Norbert Waldöfner has been working for blue inspection body GmbH, an ISO 17020 type A accredited service provider for GMP audits, since 2011. Since then, he has audited more than 200 companies worldwide, including manufacturers of starting materials and active ingredients for pharmaceutical products, as well as other suppliers and service providers (e.g. packaging manufacturers and logistics companies).


Cornelia Wawretschek has many years of practical experience in the fields of pharmaceutical processes and analysis with a focus on the development of solid, semi-solid and liquid dosage forms, sterile production and investigational medicinal products. She worked as a freelance consultant for many years.


Vera Werner has been working as a process expert in packaging at Novartis Pharma Produktions GmbH, Wehr since 2015. During this time she has gained a lot of experience in all aspects of the packaging process.


Dr Martin Wesch is a lawyer and co-founder of the law firm WESCH & BUCHENROTH in Stuttgart. The firm specialises in business and commercial law. From 1994 to 2011, he was Managing Director of the Gütegemeinschaft Pharmaverpackung e.V. (registered quality grading association for pharmaceutical packaging).