Richard Denk has 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. He founded the expert con­tainment group of the ISPE DACH eight years ago. 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.

James is the current Head of GMP Compliance at Franz Ziel GmbH and actively involved on projects for Pharmaceutical, Biologics and ATMP product GMP manufacturing, specifically Aseptic manufacturing Fill & Finish projects. Based in the UK James has a global support role and additionally acts as a Senior Consultant for Franz Ziel supporting Contamination Control Strategy: CCS preparation across a number of international manufacturing sites. 

Ex-Chairman, honorary member of the PHSS: Pharmaceutical and Healthcare Sciences Society, a Not-For-Profit educational platform for GxP and current leader of PHSS special interest groups on Aseptic processing and Biocontamination. PHSS Co-lead of Focus group for Annex 1 revision and implementation – PHSS was one of the European Commission appointed commenting platforms in the Targeted Consultation process.   Co-lead of PHSS focus groups on Control strategies (CMC & GMP) including Annex 1 Contamination Control Strategy (CCS) Guidance (now published).

Dr Anne Orillo started her carrier in Pharma as a Post-Doc researcher in immunology at Otago University, New Zealand following her Pharmacy qualification and PhD at the Free University, Berlin.  From 2006, experiences across Technical R&D in Biologics formulation development followed by Technical Operations Supply Chain Management preceded later roles in Steriles production.  Since 2022, Anne has focused on the process transfer of Sterile products as Site Validation Lead at Novartis Stein. More recently she is directly involved in Health Authority audit site representation and Regulatory Filings. 

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.

Alberto is a pharmacist with 15 years of multinational experience in the pharma and biotech industries.

In his first roles he was responsible for Quality Assurance, Quality Systems and Quality Compliance for sterile products.

In his current position with Takeda’s Global Sterility Assurance and Microbiology team he has had a pivotal role on the company-wide implementation of Annex 1. His expertise lies with Aseptic Process Simulations, Contamination Control Strategies and application of Quality Risk Management to aseptic production. This can be summarized in his motto: “Think Aseptic”.

He is an invited speaker at industry conferences and is active in industry collaborations.

Steve has a Masters’ degree in Business Administration and has joined DuPont in 1995. After having held various positions within the company, he is currently the EMEA Training Manager and critical environments specialist for DuPont Personal Protection, the chemical protective & cleanroom garments business that Steve has been working for since 2003. A specialist in cleanroom & chemical protective garments, his articles were published in several specialised magazines (such as Salles Propres, Cleanroom Technologies, FarmaEspaña Industrial, Ascca News, Clean Air & Containment Review, C2 MGZN, SifaPlus or IOSH Magazine) and he has spoken at various events (such as Tema Renrum (Sweden), Pharmaceutical Cleanroom Technology Europe (UK), ContaminExpert (France), A3P International Congress (France), R3 Nordics (Finland), Reinraum Lounges (Germany), PHSS Annual conference (UK), PharmaForum 2023 (USA), SMi's 2^nd Annual Next Generation Pharmaceutical Cleanroom (UK), 4^th Annual HPAPI Summit or Cleanroom Expo (DK) or Cleanroom Forum (South Africa). Steve is providing training sessions on the selection and safe handling of chemical protective garments used in, amongst others, pharmaceutical production and GMP grade A/B, C/D cleanroom operations as well as giving technical support to health and safety specialists.

Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK) where he started in 1984 with Glaxo Verona (Italy). During his distinguished career he led a series of technology-driven process improvements using scientific methods, while achieving GMP compliance and regulatory approvals mainly for aseptic processes and sterile products.

Today Gilberto is the Global Consultant and Subject Matters Expert for GDM Pharma Consulting. In this role he collaborates and consults with global pharmaceutical companies to develop and implement science-based strategies and processes that utilize Quality by Design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes.

He’s also a qualified training for the most important regulatory agencies. 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, regulations interpretation and methods.

Dennis started working at Roche in Mannheim in 2010. After his apprenticeship as a chemical laboratory worker he completed his part-time Bachelor Professional of Pharmaceutical Production and Management (CCI) in 2018 as best of chamber. Additionally he now has completed his B.Sc. in industrial pharmacy at the University of Applied Science Kaiserslautern. After his apprenticeship, he started working as a chemical laboratory worker in packaging materials incoming inspection in 2014 and got promoted as a foreman in the laboratory in 2017. In 2020, Dennis worked as a team lead in packaging and kitting of insulin delivery systems at Roche Diabetes Care. Since 2022, he is working as process validation engineer with main emphasis on aseptic process simulations in Roche Mannheim sterile drug product manufacturing.

Alan is a highly experienced, self-motivated, enthusiastic Process Engineer who has a passion for technology having worked in various engineering roles within the Biopharmaceutical industry over the last 25 years, including Project lead, Process Engineering Manager for aseptic process start-up, Process/ Technical Lead and Program Lead in Fill Finish.

Comfortable working in a fast-paced and demanding environment and leading functional teams to successful delivery of Biopharmaceutical manufacturing processes/programs inclusive of Fill Finish Isolated filling lines with freeze dryers, Syringe and Cartridge Inspection systems, manual and automatic respectively, high speed packaging lines and program management of product transfers to site.

In his role as SME with PM Group, Alan has worked with several international clients in the Biopharmaceutical & Med Tech industry on concept, feasibility studies through to leading robotizied aseptic filling projects. Alan has conducted contamination control assessments based on Annex 1 and also interpreting and providing guidance on Annex 1 requirements for clients. 

Alan has presented case studies on Fill Finish Biopharmaceutical processes at several international events including PDA, ISPE, ECA and Pharma/MedTech Expo Dublin.

He is an active member of PDA Ireland, a member of ISPE and was lead organiser (through PDA Ireland) for several Annex 1 events in recent years.

Dr Ulrich Herber started his career in the pharmaceutical industry at Sartorius as Product Manager for their validation services. He then moved to Concept Heidelberg where he was the Operations Director of the business segment “Microbiological Quality Control and Biotechnology”. Later on, Dr Herber headed the European organization of Accugenix. In his current role at Charles River he leads the global scientific portfolio management activities for the Microbial Solutions division. Dr Herber is co-author of scientific papers on advanced technologies applied in microbiological quality control. He has held several talks covering developments in the area of alternative microbiological methods and is an Advisory Board Member of the Pharmaceutical Microbiology Working Group at the European Compliance Academy.

Ruben van der Galiën is a pharmacist with over 5 years of experience within the pharmaceutical industry. In 2016, he graduated as a pharmacist at the University of Groningen and received his MSc-degree.

After working for several years in hospital pharmacies, he started to work as a QA specialist / pharmacist at GE HealthCare in 2019.  As of 2021, he became Qualified Person at GE HealthCare Eindhoven, The Netherlands. Currently, he is responsible for amongst others batch release activities, complaint handling and audits.  Together with a multidisciplinary team, he was also responsible for setting up the Contamination Control Strategy together (CCS) and keeping it up-to-date. In 2023, he published a scientific article in PDA Journal on the set-up of a CCS applying the HACCP methodology.

James Smith is an applications scientist at Croda Europe, where he specialises in studying the effects of excipients on small molecules and proteins. His work revolves around optimising formulations for various protein modalities and platforms, addressing their unique excipient challenges. James has a deep understanding of excipients and their impact on drug delivery, stability, solubility, and efficacy. He further investigates excipient impurities and their potential direct effects on active pharmaceutical ingredients, emphasising the importance of using high-purity excipients in pharmaceutical formulations. James holds an MChem degree from the University of Liverpool and completed his Ph.D. at the Stephenson Institute for Renewable Energy.