GMP for Pre-Filled Syringes (PFS) - Live Online Training Development, Manufacturing & Control

GMP for Pre-Filled Syringes (PFS) - Live Online Training

Course No 19026

This course is part of the GMP Certification Programme "ECA Certified Packaging Manager". Learn more.

Note: All times mentioned are CEST.

Costs

ECA-Member*: EUR 1690,--
Non ECA Member*: EUR 1890,--
EU/GMP Inspectorates*: EUR 945,--
APIC Member Discount*: EUR 1790,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Markus Busch, Vetter, Germany
Jean-François Decoster, UCB, Belgium
Susanne Hall, Vetter, Germany
Peter Huonker, FRÜH, Switzerland
Horst Koller, HK Packaging, Switzerland
Dr Bettina Rietz-Wolf, GMP Inspector for EMA and local Government, Germany
Dr Helen Sauter, Vetter, Germany

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 Assuranceƒ

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.

Programme

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
 
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
  • 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
 
 
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

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