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.

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. Olivier Chancel is a doctoral pharmacist, graduating in technological pharmacy, quality control, and management. He is currently a sterility and aseptic practice assurance expert and formerly head of performance and pharmaceuticals in Merial, Toulouse, France. He provides corporate support for sterility and aseptic processes to Merial sites. He used to work in the pharmaceutical industry for 15 years in various positions including pharma­ceutical research and development, quality assurance, quality control, proj­ect management, and production for both solid and injectable dosage forms. He has published a number of papers in peer-reviewed journals relating to cleanroom activities or aseptic practices and also presented/moderated vari­ous industry forums in Europe and the US (PDA, A3P, SFSTP, SMI, ASPEC, ECA, PHARMIG).

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.

Since January 2015, Zinaid Dzinovic has been the program manager MES at Novartis Pharma Stein AG, in Stein, Switzerland. Zinaid is accountable for MES PAS-X V3 rollout including technical equipment integration and replacement of legacy systems in the Novartis sites in Stein. He is furthermore a member of the unit for strategic planning & PMO Stein Steriles, leading the digital transformation initiatives and projects. In parallel, Zinaid held the position of global business process integration lead until 2018 at Novartis AG, in Basel HQ, Switzerland. His core responsibility areas focussed on the strategic plan­ning of global Novartis MES templates and roadmap such as the development of global MES governance and process structures. In addition, he was leading the global process harmonisation projects within the Novartis Steriles plat­form. Before taking on his current position at Novartis, Zinaid was team leader at Werum IT Solutions GmbH, in Lüneburg, Germany. Since 2018, Zinaid has been a member of the advisory board MES and process minds. He holds a diploma in business science from the Osnabrück University, Osnabrück, Ger­many, and a master’s in business process and supply chain management from the Linnaeus University, Växjö, Sweden.

Nicola Rutigliani holds a master’s degree in pharmaceutical chemistry from the University of Bari “A. Moro” and a specialisation in industrial pharmaceuti­cal technologies from the University of Rome “La Sapienza”. Before joining Merck KGAA in 2014, he worked for different CMOs pharma companies hold­ing positions in manufacturing, QC and project management. In his first four years at Merck, Nicola led the manufacturing science and technology depart­ment at Bari Site, dealing with commercial products life cycle management and process validation for both fill and finish and medical device areas. Since 2018, he has been working as the technology transfer manager for NBEs and biosimilars for all immune-oncology and immunology products manufactured at Merck – Bari Site. He has experience on GMP manufacturing process design and validation (QbD) for both stainless steel and single-use technology.

Andreas Kerschbaumer gained a diploma in chemistry and a BSc in inno­vation management. He started his professional career at Fresenius Kabi Austria in 1995 and was responsible for development and validation of ana­lytical procedures and head of the laboratory “Spectroscopy”. Starting in 2007, he was involved in the implementation of pre-filled syringes within the Fresenius Group in a leading position. In February 2010 he became the global project manager and responsible person for the center of competence for pre-filled syringes. In September 2014, Andreas changed to Novartis as deputy head of manufacturing for compounding, filling and visual inspec­tion. In this function he was responsible for the implementation and quali­fication of compounding, filling and inspection processes and going live of the manufacturing area. Since October 2018, Andreas has been focussed on visual inspection and especially on automated visual inspection.

Maximilian Augustin holds an MSc in biology. He joined Roche Diagnostics GmbH (Pharma Division) in manufacturing science and technology (MSAT) as a qualifica­tion engineer and process validation manager in 2014. For more than four years, he has been responsible for media fills/aseptic process simulation in sterile drug product manufacturing in Mannheim, Germany, and writing of pharmaceutical technical regulatory dossiers and validation of sterilisation and cleaning processes.

Christa Myers has been in the pharmaceutical industry for over 25 years and is a leader and subject matter expert. Christa is a well-recognized speaker at conferences and is frequently on-stage teaching others about regulatory requirements, operational issues and what to expect in the future of the in­dustry. Christa champions approaches that integrate strong project execution and technical solutions. Christa is on the steering committee for the ISPE community of practice for sterile products processing, a certified ISPE instructor of the sterile product processing baseline guide, the chair of ISPE’s women in pharma group, as well as an author of the most recent ISPE sterile processing baseline guide. Christa provides guidance and leadership to clients on how and when to utilise common or innovative solutions and continuously promotes the technical growth of people willing to learn more to advance the industry. She was recently awarded an honour as one of the 2019 Influential Women in Manufacturing.

Magnus Stering is the senior product manager for all filter integrity testing related topics at Sartorius Stedim Biotech. He does regular seminars around the globe on integrity testing and the draft version of Annex 1 as the official Sartorius subject matter expert. He has also given trainings at conferences and is familiar with the PDA technical reports and texts of regulatory bodies. In addition to that he has a lot of experience with customer audits and train­ings, process improvements, troubleshooting related to filter integrity testing, gas and liquid filtration applications and SIP/CIP. Magnus holds six patents, all related to filter integrity testing and bag testing. He has also written and co-written several peer reviewed technical articles in scientific publications.

Matthias Angelmaier has a bachelor’s degree in industrial and mechanical en­gineering as well as a master’s degree in business development. He joined Robert Bosch GmbH in 2009. During his first three years, he was a project manager for handling complex customer projects. Since 2012, he has been the globally responsible product manager for barrier systems and isolator technology. His expertise includes process engineering, sterilisation, bio decontamination and glove testing systems.

Prior to joining WMFTG, Dr. Sade Mokuolu was employed at Pall Life Sci­ences as European technical manager for analytical chemistry, providing technical direction on extractables and leachables (E&L) studies of single-use systems. She has presented at international conferences on E&L testing on behalf of the Bio-Process Systems Alliance (BPSA), as well as delivered training to the TGA, the Australian regulatory agency and European GMP inspectors. Additionally, she has extensive pharmaceutical manufacturing experience gained whilst employed by SAFC and Aesica Pharma as a senior process, research and development chemist. She holds a BSc degree in chemistry from the University of Sussex and a doctorate in organometallic chemistry from the University of Nottingham. Her first-ever post was a post­doctoral research fellow at the University of Leeds.

Isa Alkan is director of sales and project management at SBM, a Bosch Pack­aging Company located in Austria. He joined the company in 2010 and is expert in sterilisation and process technologies. SBM developed and launched also a new freeze dryer in 2018 as part of a complete line strategy from Bosch Packaging. Before, he worked as sales, marketing and business development manager in the field of medical devices. Isa has a master’s degree in electrical and biomedical engineering.

Peter Koger has been active in the life science industry for over 40 years. His first 12 years were spent working in different laboratories in microbiology and the remainder working for various international companies, active in the life science/pharmaceutical industry. For the last 20 years, Peter has been a techni­cal resource to the pharmaceutical industry in relation to viable monitoring and cleaning and disinfection and other aspects related to contamination control. Since 2002, he has been a frequent industry speaker and since 2004 he’s been a faculty member speaking with frequency for the PDA and other training insti­tutes. Since 2005, Peter has been working with Veltek Associates Inc., a leading manufacturer of sterile disinfectants, detergents, viable monitoring equipment and several other innovative products focussed on the pharmaceutical industry. Peter is one of the co-authors of PDA technical report TR70. His role is that of sales and business development manager responsible for Europe and Asia.

Cosmin Vatră is the creator of the AseptSoft platform, which promises to integrate the actual software, mainly used by process designers, into one workflow oriented on the process. This innovative platform helps the engi­neers to simply develop the process with the mouse-click, to simulate it by colouring the P&IDs components and automatically release the documen­tation. All these ideas were born through personal experience in pharma projects, when he started to cooperate, since 2011, with companies like Pall, TecnInox, Fedegari and others. Due to the previous eight years of research and software developing background, Cosmin developed first the AseptSoft platform for his own designing needs and has live tested different versions since 2015. In 2018, Cosmin started a cooperation with the Swiss company Aseptconn and he joined its team in 2019.

Chuck Raye holds a bachelor’s in mechanical engineering and has nine years of experience in the bioprocessing industry at Merck KGaA. For the first seven years of his career, he held engineering roles that involved designing and validat­ing single-use (SU) components and systems, as well as supporting operational teams in the manufacturing of SU systems. In his current role as Merck’s global product manager of SU final fill products, he works with customers, R&D and operations to develop solutions that advance SU technology in sterile filtration and aseptic filling applications.

Enrico Zanetti holds a master’s degree in agrochemical sciences. He’s been working in the pharmaceutical field for many years, mostly on sales and busi­ness development of drug delivery and medical device companies taking care of European and far Eastern countries. After several years in the sales field he decided to improve his technical background by joining the R&D of a medical device company, working first as project manager, and then managing the R&D team located in the Swiss branch for about seven years. He also worked as a consultant, in 2017, for many companies, supporting them in finding new businesses/products/drug licenses, etc., and providing support to those companies interested in entering the medical device respiratory business. He recently joined Swissfillon to support the take-off of the business projects with all companies interested to partner with Swissfillon, a CDMO fill and finish company, with fully automatic systems, working in GMP sterile condi­tions, specialised in filling of biopharmaceuticals and high-potent products for clinical trials and for the commercial launch of vials, syringes and cartridges.