Since April 2017, the European Pharmacopeia allows to produce Water for Injection using other methods than distillation. Meanwhile, the additional water quality "Highly Purified Water" could be found in the Ph. Eur. but will be removed in April 2019. This means a huge change in the regulatory situation for the pharmaceutical companies. A new Q&A document had been launched by the EMA, but some topics remain unclear. Therefore, the ISPE D/A/CH CoP water and steam has discussed all questions extensively for 1.5 years and written down their position.
This webinar provides insight into the thoughts of the ISPE D/A/CH experts and additionally addresses the following questions:
- What are suitable technologies for the final treatment step of a cold WFI system?
- How can the final treatment step be validated?
- How much control and oversight is needed for a cold WFI system?
- Why did we set up a new standard to determine the cut-off of an ultrafiltration module?
- Help, HPW does not exist anymore! What can I do? Do I have to upgrade my existing HPW system now?
- How could a requalification from HPW to WFI be carried out?
Meet the Presenter:
Fritz Röder is a recognized expert in the pharmaceutical industry. He has worked in a number of different positions which has allowed him develop a deep understanding of the different perspectives in a company. Mr. Röder has large experience in pharmaceutical media supply, GMP environments and the processing of solid, semisolid and liquid (sterile) dosage forms. Over recent years, he has been involved in several audits and inspections. As a member of the EDQM working group “water”, the ISPE DACH expert group “water & steam” and the PDA, he has a broad network and is contributing to international standards. After completing his studies, Fritz Röder started working for a facility engineering company where he acquired the necessary technical knowledge and experience. Afterwards, he worked as a responsible operator and also in the procurement of all water systems for a medicinal product manufacturer for solid dosage forms. He then took on a position at Bayer AG Grenzach where he managed various larger projects involving semi-solid and liquid sterile dosage forms and took part in an important FDA inspection. From 2015 to 2017 he was engaged as a project leader at Allergan plc. Since June 2017 he is working as Senior Manager Validation, Qualification & Engineering at Merck KGaA, Darmstadt (Germany). Fritz Röder is a member of the International Society for Pharmaceutical Engineering (ISPE), ISPE D-A-CH Expert Group “Water and Steam” and of the PDA (Parenteral Drug Association).=