New authors


Siegfried Schmitt provides consulting services to medical device manufacturers and the pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of quality management systems and competitive compliance. His declared interest is in reliable, effective and efficient quality systems to ensure compliance and, not least, data integrity.


Peter Schober is Principal Consultant at gempex GmbH and advises clients in the life science industry in the areas of IT compliance, computer system validation and organisation.


Thomas Schreiner has been Head of Quality Management, EHS & Vigilance of the COO Organisation since 2022. Before that, he held different positions in the company. His tasks included sterile production, qualification and validation, consultancy and compounding. He works as a speaker on specific topics in the area of GxP compliance.


Stephan Schwarze has been Head of Counterfeit Protection since 2005. He has developed and implemented processes to prevent counterfeit medicinal products and is a recognised expert in this area. He is involved in different working groups for national and international associations and holds presentations on the subject of preventing counterfeit medicinal products.


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.


Florian Sieder is the Branch Manager responsible for the Vienna office of CLS Ingenieur GmbH. He leads a group of experts who provide high-quality GxP services in the areas of engineering, qualification, validation and standard-compliant process instrumentation.


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 has been with Takeda since 1995. After being responsible for different validation topics (e.g. facilities incl. control systems and process control systems), he is now responsible for representing qualification in projects at the manufacturing site in Vienna.


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 at Novartis Pharma Produktions GmbH since 2015. She fulfilled the role of process expert in packaging here until the summer of 2021. During this time she has gained a lot of experience in all aspects of the packaging process. Especially the continuous development and adaptation to new regulatory requirements provided deep insights into various systems.

Subsequently, Vera Werner took over the management of QA Compliance at the site and is responsible for a wide spectrum of GMP compliance matters. Since September 2022, she has been Laboratory Manager for Starting Materials.


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 – dissolved).