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.

Don Singer is a senior microbiology technical consultant, North America, for Ecolab, and a fellow in the American Society for Quality. He was formerly a GSK senior fellow. Don has been chair of the USP general chapters - microbiology committee of experts and a member since 2000. He is a certified GMP professional, a certified specialist microbiologist, a member of the European pharmacopeia group 1 microbiology committee, and a certified six sigma green belt. Don is also an adjunct professor in the biopharmaceutical quality graduate program at the University of Maryland, Baltimore County. Don’s career spans over 40 years of research and quality control.

Simone Biel is a Senior Regulatory Consultant and provides regulatory expertise to our customers and internal stakeholders with a focus on Single-Use Technology and filtration. Over the years, Simone has supported biopharmaceutical drug manufacturer’s implementation of Single-Use Technology in their manufacturing process and gained a deep understanding of market needs and industry trends in this field. Her objective is to ensure that product performance meets quality and regulatory requirements.

Simone holds a Ph.D. from the University of Frankfurt in Microbiology.

Oliver Schläfli, PhD, working 20 years plus in pharmaceutical industry. His work history includes positions as GMP inspector for vaccines and labile blood products in the Swiss Federal Office of Public Health (SFOPH), associate professor for pharmaceutical technology at the University of Tromsö, Norway, various positions in Quality and Technical  Research and Development (TRD) at Novartis and lately head of Quality at Lonza.

Amnon Eylath is a seasoned quality leader who's experienced in the complete life cycle of biological and small molecule drug development, from discovery through nonclinical and tox studies, clinical trials, process and method development, GMP manufacturing, validation, regulatory submissions, and US/EU/MHRA commercial product approvals. Amnon has direct experience with the manufacturing of biomolecules and peptides, cell and gene therapy, and with developing and troubleshooting aseptic processes, including design and fabrication of isolators and the implementation and validation of highly effective decontamination and sterilisation technology. Amnon has worked at various capacities in multinational companies, such as Amgen, Ely Lilly, and Genzyme-Sanofi, as well as at cell therapy companies such as Cellcor Therapies, Histogenics, and Minovia Therapeutics. Currently, Amnon is vice president of quality assurance at Rentschler Biopharma Inc. in Milford, Massachusetts, managing the GMP quality system, overseeing the quality and compliance of clinical and commercial biomolecule therapeutics and intermediate manufacturing, health authority inspections, client audits, and implementation of continuous improvement methods to the quality management system and related processes.

Thomas Schwarz started his career 20 years ago at Sanofi in Frankfurt in the area of recombinant insulin manufacturing. In 2006 he moved to Novartis, where he held several management positions (in Switzerland and US) with increasing responsibility within biotech manufacturing, quality assurance, and clinical supply operations. Before joining SiO2 Material Science as chief commercial officer, he served as head of strategic planning for Takeda.

Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK). Over his last five years with GSK, Gilberto led a series of initiatives implementing process analytical technologies (PAT) and rapid microbial methods (RMM) that improve quality and process understanding while yielding significant cost savings. In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today, Gilberto was the technical science director for Europe and Asia for Veltek Associates Inc., and in this role, he collaborated with pharmaceutical companies and authorities to develop and implement science-based strategies and processes that utilise quality by design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes. With his extensive experience in sterility assurance and microbiology, Gilberto has the capability of supporting pharmaceutical manufacturers in a wide variety of aseptic processes, machinery, and methods.

Miriam Guest is a principal microbiologist at AstraZeneca, working in the new modalities and parenteral development group, based at their Macclesfield site in the UK. Miriam has worked in pharmaceutical development for over 20 years in a range of roles, from the microbiology laboratory executing method development to being a facility microbiologist supporting a multi-product aseptic manufacturing facility, as well as some time in formulation development. She returned to microbiology in 2012.

In recent years, she has designed and developed AstraZeneca’s “21st Century Microbiology Strategy” to innovate, industrialise, and implement technology solutions to drive efficiencies and process robustness benefits with the AZ global network. She leads the global microbiology forum at AstraZeneca, which connects microbiologists from approximately 25 sites across the globe – here she fosters a culture of collaboration to support the quality function in driving standardisation and optimisation projects. The forum is an open learning network with broad representation from other skill areas as well key contributions from microbiology.

Miriam is an active committee member of the pharmaceutical microbiology interest group (Pharmig) and represents AstraZeneca on a range of cross industry collaboration networks. Outside of work, there is rarely a quiet moment – between being a taxi driver for her two teenage daughters and walking her two dogs, she also enjoys keeping active by playing football and squeezing in gym visits where she can.

James L. Drinkwater is the ex-chairman and an honorary member of the Pharmaceutical and Healthcare Sciences Society (PHSS), a not-for-profit educational platform for GxP and current leader of PHSS special interest groups on aseptic processing and biocontamination. He's the PHSS co-lead of Annex 1 revision (sterile medicinal product manufacturing) focus group and contamination control strategy (CCS) guidance initiative. James is also the current head of GMP compliance at Franz Ziel GmbH and actively involved in pharmaceutical, biologics, and ATMP product manufacturing as well as fill and finish projects. Based in the UK, James has a global support role and is also a qualified trainer on aseptic processing.

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.

Sergio Cuevas is a well-seasoned and experienced packaging materials engineer with beyond 15 years of experience. He has developed his career in Alcon, Novartis, Sanofi, and Boehringer-Ingelheim. His roles in all of those companies in the departments of supply chain and production have provided him a wide expertise in the pharmaceutical and medical devices industries. He is specialised in packaging projects coordination thanks to a broad vision of the entire packaging lifecycle (quality assurance, validation, production, etc.). Sergio carried out different studies related to design, production, and management of packaging. He is currently studying a degree in chemistry.

Pino Cabrera is a senior pharmaceutical consultant with 15 years’ experience in the pharmaceutical industry. Pino has knowledge and practical experience in process and cleaning validation, equipment, utilities, facilities qualification, and risk analysis, quality system implementation, and GMP regulation compliance. As a GMP auditor, Pino has performed audits on suppliers of excipients, API and finished product manufacturers, as well as internal audits and gap analysis for GMP compliance.

Christian Scarpato is a sterile manufacturing fill and finish expert with almost 12 years of experience in pharma companies. In the last years, he worked on the design, installation, and start-up of three new production lines (vials, cartridges, and syringes) with cutting-edge technology like isolator in Merck's Bari site. He currently leads the process engineering in Merck Bari.

He graduated with honours in chemical engineering from Federico II University of Naples.

Chris Berridge is a global technical consultant, Bioquell specialist for Ecolab Life Sciences. He has over seven years of experience working in graded cleanrooms for pharmaceutical manufacturing as well as biosafety laboratories and biomedical facilities. He is a bio-decontamination specialist and subject matter expert on Bioquell technology, products, and services and their uses in the life sciences and healthcare markets. He also manages projects focussing on the implementation of Bioquell’s more complex integrated decontamination systems, including detailed design, building of bespoke documentation, and managing the validation and other siteworks. Chris is also an industry speaker at technical conferences and in webinars.

Fabian Stutz is the CEO and head of sales with Pharmabotix AG, a company that provides clients with innovative robotics and automation solutions for the pharmaceutical industry. From building an effective team to maintaining a large customer network, Fabian is adept at driving business development while delivering exceptional service to customers with a direct communications approach. He is passionate about trying new ideas and providing honest feedback on feasibility to ensure customer satisfaction.

Bianca Bohrer studied pharmaceutical technology at the University of Applied Sciences in Primasens (Germany). Early on, she gained experience in GMP-compliant work, especially in the area of qualification. As a division manager for analytical chemistry and a manufacturing manager for parenterals, she was able to further deepen these skills. Since September 2014, she has been head of quality control, and since 2019 she's been the managing director of PharmBioTec GmbH, a non-profit research institute, and since 2020 she's been the managing director of Topmedicare GmbH and PSM GmbH - both §13-AMG contract manufacturers for aseptic products

Dr. Sebastian Trennheuser is the newest member of the Topmedicare and PSM family. After studying pharmacy at the University of Freiburg (Germany), he recently completed his PhD in pharmaceutical technology at the University of Heidelberg (Germany). His focus will be scientific project management

Nicole Zangl has a degree in biochemistry and food and biotechnology, plus more than seven years of experience in the biotech industry. She’s a subject matter expert for mixing technology and magnetic coupled agitators, responsible for global business development of mixing technology and products.

Julian Petersen started his career in the pharma industry at a German fill and finish system supplier as a project manager. After a short timeout in the semiconductor/metrology business, Julian returned to the pharmaceutical fill and finish business as a sales director responsible for the DACH market.

Now leading business development and product management, Julian is passionately focussing on emerging and future technologies to meet the requirements of the vastly changing pharma market.

Julian is an active member at ISPE (SIG robotics) and PDA (PtC aseptic fill and finish). He enjoys public speaking and exchanging knowledge.

Susan B. Cleary, B.CS, EMBA, is the director of product development at Novatek International.  Susan has more than 20 years of experience in designing, developing, and implementing large scale quality management and contamination control systems. Susan works with pharmaceutical, biotech, and medical device companies and specialises in data integrity and regulatory compliance for cleanroom control and is highly experienced with streamlining quality processes and digitalising data for GMP and Annex 1 compliant systems.