Dr Bettina Rietz-Wolf
Regierungspräsidium Tübingen
Referent:innen
Note: All times mentioned are CEST.
Zielsetzung
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.
Hintergrund
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:
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.
Zielgruppe
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
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
Note: Provisional timetable, the actual schedule may vary depending on the situation.
Programme Day 1
09.00 - 09.15 h Welcome & Introduction
09.15 - 11.00 h
Basics & Regulatory Overview / GMP Issues in Inspections
- Applicable regulations and guidance
- The new Annex 1
- Personnel:
- Qualification & disqualification
- Training
- Protective clothing
- Gowning and gowning validation
- Personnel Monitoring
11.00 - 11.15 h Short Break
11.15 - 12.15 h
PFS made from Glass or Polymer
- Materials
- Manufacturing
- Sterilization methods
- Design
- Pros and Cons
12.15 - 12.45 h
Q&A Session 1
Q&A Session 1
12.45 - 13.45 h Break
13.45 - 14.45 h
PFS and Needle Safety Systems
- Regulatory Requirements
- Active vs. Passive Systems
- Design Considerations
- Examples
14.45 - 15.45 h
Fill-Finish Processes for Prefilled Syringes
Fill-Finish Processes for Prefilled Syringes
- Bulk and pre-sterilized
- RABS and isolators
- Annex 1
15.45 - 16.00 h Short Break
16.00 - 16.45 h
Pen-and Auto Injector Assembly Processes
- Assembly processes of the syringes into injection devices (auto-injectors, safety systems, etc.)
16.45 - 17.15 h
Q&A Session 2
Q&A Session 2
Programme Day 2
09.00 - 09.45 h
Container Closure Integrity
- Requirements for CCIT
- Method development and validation
09.45 - 10.45 h
Process Simulation / Media Fill
- Media Fill Design
- Worst-case parameters & requirements
- Validation of processes with Media Fills
- Trends with regards to Media Fills
10.45 - 11.00 h Break
11.00 - 11.45 h
Visual Inspection
- Requirements
- Method development and validation
- AQL testing
- Automated vs. semi-automated vs. manual inspection
11.45 - 12.30 h
Sterile Secondary Packaging: Case Study
- Sterile secondary packaging of PFS
- Validation of sterilization methods
12.30 - 13.00 h
Q&A Session 3
Q&A Session 3
Dieses Seminar/Webinar kann nicht gebucht werden. Alternative Termine für dieses Seminar/Webinar und ähnliche Veranstaltungen finden Sie in der Übersicht nach Thema..
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* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Packaging Manager"
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E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Seminarprogramm als PDF
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