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PDA EU00175 Extractables and Leachables for Parenteral Applications Series

Nov 08 - Nov 10, 2021
1:00 PM
-
6:00 PM
| W. Europe Standard Time
Online
  • Education
  • Virtual
  • Europe
  • Online

Overview

When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements to further investigate the materials that will be in contact with the drug product either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations; recently, quality issues, i.e. for biopharmaceuticals, have become an additional concern.

This education series (pre-recorded webinars combined with live discussions at the end of each day) will look at Extractables and Leachables (E/L) from many different angles:

  • Regulatory Requirements and Guidelines
  • Materials and Polymer Science
  • Mechanisms of Leaching and Material-Drug Product Interaction
  • Analytical E/L Methodologies
  • E/L Study Design for Different Packaging Systems
  • Large Volume Parenterals
  • Lyophilization Applications

Several interesting case studies on the above topics will also be presented.

At the end of each day, trainers are available to answer questions in a Live Q&A session.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Monday, 8 November 2021

    13:00 – 15:00
    Session 1: Introduction - Helicopter View - Setting the Stage
    Dennis Jenke

    15:00 – 17:00
    Session 2: Polymers 101 and Mechanism of Leaching
    Piet Christiaens

    17:00 – 18:00
    LIVE Q&A

  • Tuesday, 9 November 2021

    13:00 – 15:00
    Session 3: Analytical and Toxicology 101
    Dries Cardoen and Kevin Breesch

    15:00 – 17:00
    Session 4: Do’s & Don’ts Extractables and Leachables
    Dries Cardoen

    17:00 – 18:00
    LIVE Q&A

  • Wednesday, 10 November 2021

    13:00 – 15:00
    Session 5: Single Use Systems – Biodisposables and Simulation Studies LVP
    Karen Pieters and Dennis Jenke

    15:00 – 17:00
    Session 6: Small Volume Parenterals – Rubbers, Lyo Applications, Combination Products
    Piet Christiaens

    17:00 – 18:00
    LIVE Q&A

Trainers

Kevin Breesch
Kevin Breesch
Nelson Labs
Dries Cardoen
Dries Cardoen
Nelson Labs
Piet Christiaens
Piet Christiaens
Nelson Labs NV
Dennis Jenke
Dennis Jenke
Triad Scientific Solutions
Karen Pieters
Karen Pieters
Nelson Labs

Learning Objectives

Upon completion of this training course, you will be able to:

  • Explain in detail the current regulatory requirements for container/closure qualification form an E/L perspective.
  • Explain the upcoming changes in regulations, standards and recommendations from PQRI, USP and BPOG and how these changes could impact a future evaluation of a pharmaceutical C/C-system.
  • Understand the materials of construction – and their composition – of container closure systems, and how they could impact the safety and quality of a parenteral drug product.
  • Put together an evaluation program (review of provided documentation, analytical testing) of different types of parenteral drug product container/closure systems.
  • Perform a safety/risk assessment of analytical results, obtained after completion of an E/L study

Who Should Attend

This webinar series is intended for professionals who are involved in contamination control strategy development for sterile drug manufacturing.

  • Quality Control
  • Quality Systems
  • Quality Compliance
  • Technical Operations
  • Validation

Registration Fees

Register Now
Registration Type Price
All Participants $800

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