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Quality, Quality, Quality: from manufacture, through fill/finish to final inspection
This seminar has been designed to provide a comprehensive, practical and useable overview of the production of Pre-Filled Syringes and will provide the latest information on manufacture, packaging for fill/finish through to final (post-fill) inspection. Quality will be a key focus for the day and topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.
Those working in the area of Pre-Filled Syringes with responsibility for device programmes, product development, product life cycle management, regulatory affairs, quality assurance, combination products, drug delivery specialists, business development managers, product development managers.
Welcome and introductions
Pre-filled syringes for biotech: improvement in the manufacturing process development
Syringe manufacture from components to the final product – an overview
The next step: fill/finish for nested syringes, vials and cartridges
Visual inspection of pre-filled syringes
Secondary packaging of PFS
Design verification testing of device function for PFS
State-of-the-nation address for PFS and summary
Close of seminar
Dr. Andreas Rothmund is Qualified Person at Vetter Pharma-Fertigung in Ravensburg, Germany, an independent contract manufacturer specialised in the aseptic production of pre-filled application systems. He started his industrial career in 1985 as a lab manager. After two years he took over production responsibility for a German company specialised in eye drops and eye ointments, a position he held for nearly eight years. He joined Vetter in 1994, where he has held several positions, including Head of Production for one of Vetter’s aseptic production units. He holds a degree in organic chemistry from the University of Constance, Germany.
Horst Koller started his professional career in 1994 to work for a large pharmaceutical company in Germany managing the Process Engineering Group. He holds a degree as Dipl. Ing (FH) in Biotechnology. In 2000 he joined Schott in the business segment Pharmaceutical Packaging. He has been a key player in building the manufacturing unit for the Schott TopPac® polymer syringe within Schott AG. He held different positions including Quality Manager, Head of R&D, Manager Scientific Advisory and Manager Global Regulatory Affairs and Quality R&D. He is now CEO of HK Packaging Consulting GmbH.
He is an active member as expert of ISO/TC 76/ working groups and a frequent speaker at extractables & leachables as well as Prefillable Syringe conferences.
Dale has spent a life long career in Life Sciences & Biotechnology spanning over 28 years covering work in both the academic and industrial sectors. Following his first degree in Biological Sciences and spells at Porton Down & Pittman Moore vaccines (Formerly Glaxo Animal Health) developing vaccines/adjuvant systems, Dale settled back into the biotech industry proper developing therapeutic Monoclonal Antibodies at Celltech in Slough UK.
Dale successfully undertook a PhD at Pfizer Drug Discovery Sandwich, Kent UK & the University of Nottingham on peptide drug candidates before moving out of academia and into the supply industry in the field of robotics and automation for the biopharmaceutical industry. Dale progressed from Product Specialist to Managing Director of an independent Life Science company until moving to his role as Director of Business Development for the Optima Group pharma, Germany and more recently to ATS Sortimat.
He has a number of scientific publications to his name and has written a number of articles for journals and magazines and regularly gives presentations at numerous international conferences in the field of Fill/Finish.