Pharma
At this Summit we will highlight the latest trends and techniques in Aseptic Processing.
Read moreThis premier event provides the appropriate platform to share ideas and network with peers involved in pharmaceutical manufacturing, aseptic fill and finish, quality control, engineering, and container development. These and other hot topics will be discussed by leading experts from the industry. All of which, will provide a broad overview of regulatory updates, current technical trends, and innovations as they pertain to Aseptic Processing.
Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Senior Managers, Scientists, Chemists, Engineers and Fellows specialising in:
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Nigel is a recognized SME (subject matter expert) in pharmaceutical HVAC & CQV and is part of a global ISPE network of peers involved in critical HVAC and energy reduction within the pharmaceutical sector. He has provided co-author support for technical papers with W. Whyte, and T Eaton, whilst also authoring a number of papers on airflow performance in cleanrooms. He has co-authored a book on cleanroom management with T Sandle and co-founded the ISPE Sustainable Facilities CoP. He has been involved in ‘client side’ technical leadership on many high value cleanroom and laboratory facility designs with decades of experience.
Anthony Nye is a CQV project engineering contractor/consultant with over twenty years of experience providing commissioning and validation services to pharmaceutical and biotechnology clients. He has particular experience in the discipline of CQV project management of facility expansion/refurbishment and new build projects; from initial concept proposal through detailed design, tendering, vendor auditing, procurement, factory acceptance testing, construction/installation, commissioning, validation/verification and handover for beneficial use.
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).
Christoph Korpus graduated in pharmacy at the Goethe-University in Frankfurt am Main, Germany. He finished his PhD thesis at the Ludwig-Maximilians-Universität Munich under the supervision of Prof. Wolfgang Frieß. His research focused on the lyophilisation process development for Dual Chamber Cartridges. This included energy transfer studies and the analysis of different holder devices. For his 3 month research stay at the University of Connecticut, in the group of Prof. Michael Pikal, he was awarded with a graduate student scholarship from the German Academic Exchange Service. Since 2016, he is leading the liquid formulation stability laboratory at Merck KGaA (Germany) in Darmstadt. His current research focuses on the development of high grade excipients for final formulations.
Manfred Holzer has beeb involved in the pharma isolator business since 1995. He joined Skan in 2000. He is working in international sales & project management, as well as USA business coordination. Today, he is the responsible sales manager for Ireland/UK and the product manager for E-Beam applications at Skan.
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.
Christine brings more than 15 years of experience in management, design, construction supervision, commissioning and plant engineering of pharmaceutical fill-finish projects in the areas of injectables and oral solid dosage. She has overseen and prepared technical specifications and datasheets as well as developed process layouts, material, personnel and process flow diagrams. Christine’s experience also includes project management, cost estimating, procurement support, construction supervision and preparation of qualification documents in compliance with GMP requirements.
Gavin Wadsworth, Pharmaceutical, Medical Device & Biotech Quality Assurance Consultant for Microstar Control Systems, has over 18 years of experience in technical, quality, specialist and management roles. His experience shows that he has worked in areas from research and development (R&D), to active pharmaceutical ingredients (API) and finished products (including steriles).
A graduate in pharmaceutical sciences, his expertise lies in quality assurance & quality systems, validation, project management and risk management to name but a few. An active member of the Pharmaceutical Quality Group (PQG), Royal Society of Chemistry (RSC), Parenteral Drug Association (PDA) and Pharmaceutical & Healthcare Sciences Society (PHSS), he is always learning and advising on issues faced by the industry. He has both led and been a subject matter expert for numerous MHRA and FDA audits on new and legacy facilities. He has also overseen, written, and taken part in numerous legacy and new build projects from project conception to commercial production.
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.
Dr. Ildiko Ziegler has been a professional at Gedeon Richter for 14 years and has been leading different projects in her field for four years. She has been a distinguished validation expert since January 2014, specialising in cleaning validation and quality risk assessment in the pharma industry. Ildiko obtained a master’s in chemical engineering at the Budapest University of Technology and Economics (BUTE) in 1996. She received a licentiate degree at the Luleå University of Technology (Sweden) in 2000. She defended her PhD at the BUTE in 2000 and obtained the Géza Schay Award for her achievements in the field of physical and theoretical chemistry.
Francesco Nigris graduated from Università degli Studi of Milan in 1989, with a thesis on the European harmonisation Directive (EC Directive 86/653) on the Agency Contract. In 1991, he became Nicomac Srl export sales director and vice president. Also, in the same year became president and CEO of Nicomac Inc., (North American branch of Nicomac) incorporated in the state of Illinois. From 1991 to 2003, he actively managed projects of the Icos washing and sterilisation line of equipment by promoting the first sales of Icos Units in UK, France, Sweden and Germany; therefore, opening the markets for the thriving Italian manufacturer for which Nicomac was the sole distributor. In 1996, he coordinated the Nicomac team who worked for the ISO 9001 certification of Nicomac QA system.
In 2003, he moved to New Jersey with the mission of opening the North American market for the Nicomac line of modular cleanroom system. Since then, he has managed multimillion projects for both Icos washing and sterilisation equipment and modular cleanrooms both from the commercial and the critical technical aspects point of view. Franceso has been a ISPE member since 1991.
In 2007, he managed the transition from Nicomac Inc. to Nicos Group Inc, by incorporating the company under the state of New Jersey.
Christian Dunne is the Global Product Manager for ChargePoint Technology for the Aseptic range of products. For the past 15 years Christian has been creating innovative solutions for the Pharmaceutical, Biotech, Cell Therapy and Fine Chemical industries in the form of High Containment and Aseptic process solutions. His technical expertise experience includes supplying High Containment Isolators down to low nanogram levels; Grade A (ISO5) Sampling & Dispensing facilities, together with R&D / Production filling line RABs & Isolators.
For the past 4 years Christian has been working with Chargepoint Technology on the advancement of their Split Butterfly range of solutions in the aseptic and containment fields, handling high potent/sterile powders and small scale components, where both product and operator protection are paramount.
While working on many Aseptic applications, Christian integrated a number of different Bio decontamination systems and consequently has an in-depth understanding of their performance and application. This knowledge was key to the development of the now established Charge-Point Bio valve, used for the transfer of sterile powders in the industry. Christian is an active member of ISPE and PHSS.
Thank you for your interest!