GMP for Pre-Filled Syringes (PFS) - Live Online Training
3/4 May 2022
Course No. 19026
Speakers
Dr. Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Peter Huonker
Lonza
Note: All times mentioned are CEST.
Objectives
In this live online course you will learn which requirements for pre-fillable syringes as a packaging material are defined by the regulations. You get to know all aspects of the manufacture of pre-fillable syringes that influence the filling process and the quality of the final product. In addition practice-oriented videos and case studies will guide you through the relevant production processes, simulations and controls for pre-filled syringes.
Background
Currently there is a growing demand in the development of prefillable syringes (e.g. ready-to-fill, ready-to-use, sterile clean filling) for several enhanced Biotech applications (i.e. for the final product, the Pre-filled Syringe). However, new GMP requirements, also for the sterile packaging material (e.g. regarding validation of the sterilization procedure for the syringe), will apply with the upcoming revised EU GMP Annex 1 entitled “Manufacture of Sterile Products”.
This event will therefore deal with the current discussions and trends in the manufacture of pre-filled syringes:
GMP requirements for pre-fillable syringes / devices
PFS Design & Safety Systems
Alternatives to glass
GMP Requirements for personnel, cleanrooms, equipment & facilities
Processing of pre-filled syringes
Auto-injector Assembling
Sterile secondary packaging
Observations during GMP inspections
The presentations will be provided in a practice-oriented way (e.g. via videos) from the different viewpoints of authorities, suppliers of packaging materials / devices / services (including sterilization activities), and the pharmaceutical industry.
Target Group
This online event is designed for employees working in the pharmaceutical industry (including drug device combination products), for suppliers of packaging materials & devices and to all who have to deal with the manufacture, control and release of prefilled syringes. They key areas are
Sterile Production
Packaging material / Device development
Manufacturing / Processing / Assembling
Quality Control
Quality Assurance
Technical Requirements
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Testimonials
Seminar Programme as PDF