Aseptic Process Simulation (APS) / Media Fills - Live Online Training GMP Requirements on Validation of Aseptic Processes

Aseptic Process Simulation (APS) / Media Fills - Live Online Training

Seminar Nr. 20235

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

Note: All times mentioned are CEST.

Kosten

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Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Bettina Rietz-Wolf, GMP Inspector for EMA and local Government, Germany
Luigi Scaffidi, Boehringer Ingelheim Pharma, Germany
Dr Florian Witte, Boehringer Ingelheim Pharma, Germany

Zielsetzung

During this course you will learn in lectures and workshops
  •  The new requirements of the revised EU Annex 1
  •  How to plan a media fill in compliance with European and US GMP requirements,
  •  How to interpret the results of a media fill,
  •  How to investigate deviations and define follow-up measures and
  •  How QA should be involved

Hintergrund

In the aseptic processing of medicinal products, the product quality usually cannot be ensured by means of lab controls of the final product. Process validation by means of media fills is the only way to furnish proof of product safety, which is why it justly is the focus of regulatory requirements and official inspections.

A number of revised and harmonised international regulations, especially the FDA Guidance for Industry „Sterile Drug Products Produced by Aseptic Processing“, the EU-GMP-Guide Annex 1, ISO 13408 and the PIC/S Guide „Recommendation on the Validation of Aseptic Processes“, define highly detailed requirements, the implementation of which is critically examined within the framework of official inspections.

In general, the required media fills should be able to simulate both routine operation and worst-case conditions.

In practice, the question of practicability often arises. How should the requirements be interpreted and how can they be implemented even for special production processes or dosage forms?

Zielgruppe

This Education course is directed at staff from
  •  Production
  •  Quality Assurance
  •  Microbiological Quality Control
who are responsible for the planning and evaluation of Aseptic Process Simulation (Media fill) programmes.

It is also valuable for decision makers who have to deal with Process Simulation data within the framework of production release and Aseptic Process Validation.
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 plugin. 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

Current Regulatory Requirements and Expectations of an Inspector
  • EU-GMP Guide Annex 1
  • Regulatory changes through the new EU GMP Guide Annex 1 Draft
  • Contamination control
  • Inspection practice, questions
    • Design
    • Interventions
    • Visual inspection
    • Target, Assessment
  • Media Fill Observations
Requirements for Cleanroom Staff Qualification
  • Staff qualification
  • Staff disqualification
  • Training
  • Gowning qualification
  • Qualification with APS (success control)
  • Personnel Monitoring
Design of Media Fill incl. Exercise
  • Overview PDA TR22
  • Parameter, which have to be consider in MF design
  • Different MF design alternatives
  • Consideration of long filling times
  • Consideration of holding times
  • The role of the MF in aseptic personnel qualification
Risk Management During Media Fill (Bracketing / Definition of Simulations / Interventions)
  • Approaches and parameters for bracketing concepts
  • Classification and grouping of interventions
  • Examples of simulations
  • Influence of the barrier system
  • Examples of risk management tools
QA-Oversight
  • Regulatory requirements
  • Different approaches to QA Oversight
  • Oversight during Media Fill execution
  • Link between Media Fill Interventions and Smoke Studies
Exercise: Risk-based Determination of Interventions
 
Microbiological Investigations and Environmental Monitoring as Part of the Media Fill
  • EM and personnel monitoring during Media Fill
  • Responsibility for execution
  • Fertility testing of the growth medium
Incubation, Assessment and Evaluation
  • Important conditions for visual inspection
  • Personnel qualification
  • Evaluation methods for the Media Fill
Managing Deviations - Root Cause Analysis
  • Consequences of deviations in Media Fill
  • Retrospective and prospective evaluation
  • Relevant parameters in root cause analysis
Case Study: Managing Interventions

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