Richard Denk studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, pharmaceutical engineering, and quality control at the University of Applied Sciences in Albstadt/Sigmaringen, Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment, and eight years ago he founded the expert containment group of the ISPE DACH. The containment group published the Containment Manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

Walid El Azab is an industrial pharmacist, a qualified person and a Lean Six Sigma green belt. He is a technical services manager for STERIS Life Sciences. He provides technical support related to cleaning, disinfectants, sterility assurance and process validation. Finally, he leads audits at manu­facturer sites and workshops to improve processes and inspection readiness level. Walid is a lecturer at a pharmacy and medicine university. He has published different articles and book chapters, and he is also part of working groups on sterilisation and EU GMP Annex 1 guideline revision. He is a plan­ning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th editions), and part of the editorial committee of the PDA Letter. Walid is an observer member of the ISPE Belgium affiliate board. Finally, he is secretary of the Belgium Qualified Person Association.

Dr. Mauro Giusti holds a Master's Degree in Chemistry at the University of Florence and he is Board Certified by National Chemist association.

After completion of mandatory military service as an Army officer, he joined Eli Lilly at the Italy manufacturing plant site in 1988.  Over the 32 years with Eli Lilly, Dr. Giusti has covered several positions within the Lilly Manufacturing organization (Regulatory, Technical Services, Project Management, Quality Control, Quality Assurance, Production of oral and parenteral products, Technical Director/Qualified Person, Six Sigma Champion. Manufacturing Science and Technology, Manufacturing Procurement), dealing both with Lilly manufacturing plants as well as with Contract manufacturing in the Europe/Africa/Asia.

Among the several experiences with Lilly, he has worked approximately 5 years outside of Italy, both in United States (2.5 yrs, from 1992 to 1994) and in United Kingdom (2.5 yrs, from 1997 to 1999).

Since late 2003, with the Lilly Italia mission change from Sterile and Oral cephalosporin to Biotech products,  he has had responsibility for Lilly Italy TSMS (Technical Svcs/Mfg Science Department), with responsibility for Metrology, C&Q of facilities, utilities, and equipment, Sterility Assurance, Process Validation, set-up of new manufacturing processes and of new manufacturing technology for Biotech products, including automatic assembly of disposable Ins. pens and Autoinjectors. In September 2009 he also added to his TSMS duties,  the responsibility for Manufacturing Sourcing and Vendor Management.

In September 2019 he has taken a new role, as Advisor, Site External Network, dealing with external entities linked to the Lilly Sesto Manufacturing site (especially Universities) and leading a Lilly Global project for improvement of technical capabilities in Parenteral Manufacturing.

For more than 12 years he has served as a member of the Italy Chapter of PDA, with several participations to national and international forum both as a speaker and as chairman.

Mrs. Vinnerås has been with Fresenius Kabi since 2017, and previous to that since 2000 she worked for pharmaceutical and medical device companies such as Abbott and Pfizer within different quality departments and holding various management responsibilities and positions. Recently, as an associated senior quality consultant at ÅF Life Science, she had assignments within the areas of quality assurance, risk management, validation and education at clients such as GE Healthcare, Thermo Fisher Scientific, Fresenius Kabi and smaller life science companies. Currently, Henrietta is part of a global compe­tence center within Fresenius Kabi, supporting the companys’ pharmaceutical manufacturing operations worldwide by establishing global corporate proce­dures, performing on-site assessments, education and training, trouble shoot­ing, root cause investigations, CAPAs and continuous improvement projects; specifically within the areas of microbiology and aseptic technique.

Thomas Schwarz has a PhD in chemistry and an executive MBA. He joined Aventis in 1999 in Frankfurt, where he worked in recombinant insulin pro­duction. He has worked at Novartis since 2006 in a variety of functions in­cluding process manager of sterile manufacturing, plant manager of biotech in the US and QA/QV team leader. He is currently the head of strategic plan­ning for aseptics, which includes nine drug product sites around the globe.

Principal Scientist for Parenteral Process Development in Pharmaceutical Technologies at Merck Healthcare KGaA in Darmstadt, Germany.

Robert is a pharmacist by training and holds a PhD in Pharmaceutical Technology from the Ludwig-Maximilians University in Munich, Germany. At the LMU he gained profound knowledge in the field of formulation development of therapeutic protein-polymer conjugates. He joined the pharmaceutical industry in 2014 as a compliance expert at Sanofi-Aventis Deutschland GmbH (Frankfurt am Main, Germany) and was responsible for the industrialization of parenteral late stage projects as well as process optimization of marketed parenteral products. In 2017, he joined the Merck Healthcare KGaA (Darmstadt, Germany) in the role of a principal scientist for parenteral DP development. Additionally, he represents the head of manufacturing for the construction of a novel high containment GMP pilot plant for sterile DP manufacturing where cutting-edge single-use technology as well as latest regulatory expectations will be implemented. 

Matthias Angelmaier has a bachelor’s degree in industrial and mechanical engineering as well as a master’s degree in business development. He joined Syntegon Technology GmbH in 2009. During his first 3 years, he was a project manager for handling complex customer projects. Since 2012, he is the globally responsible product manager for barrier systems, isolator and process technology. His expertise includes process engineering, sterilization, bio-decontamination, aseptic and high-potent Isolator applications, glove testing systems as well as topics related to advanced aseptic processing. He is a frequent speaker on international symposia and conferences including organizations like ISPE and PDA

Dr. Lee is responsible for product and business development along with providing strategic direction. Before joining LLS Health, Rob held senior management positions at Novavax, Inc., Lyotropic Therapeutics, Inc., and Imcor Pharmaceutical Co. He holds BSs in Biology and Chemistry from the University of Washington and a PhD in Physical Bioorganic Chemistry from the University of California, Santa Barbara. Rob has published more than three dozen articles and five book chapters plus holds 11 issued patents and 15 provisional or PCT patent applications. He has over 30 years of experience in pharmaceutical research and development of both therapeutic drugs and diagnostic imaging agents. Rob maintains strong academic ties, including an appointment as Adjunct Associate Professor of Pharmaceutical Chemistry at the University of Kansas in the early 1990s, serving as a reviewer for both the International Journal of Pharmaceutics and Journal of Pharmaceutical Sciences, and serving on the Editorial Board for the Journal MOJ Bioequivalence & Bioavailability, The Scientific Pages of Nanotechnology, and The Journal of Analytical and Pharmaceutical Research.

Sebastian Scheler (born 1987) is a qualified psychologist and expert trainer. As CEO and Lead Psychologist (since 2017) at Innerspace - The DeepTraining Company, he is not only responsible for company management moreover for the global business development and implementation of deep training products in the pharmaceutical industry. As an expert in training transfer and human error analysis, he is also a speaker at various specialist events.