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PDA Webinar: Extractables and Leachables for Parenteral Applications Series

Aug 10 - Aug 19, 2021
9:00 AM
-
11:00 AM
| Eastern Standard Time
Online
  • Webinar
  • Virtual
  • 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 pre-recorded webinar series 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.

The following sessions will take place in this pre-recorded webinar series:

Week 1

10AUG2021 (09:00 – 11:00 UTC -5)
Session 1: Introduction - Helicopter View - Setting the Stage
Dennis Jenke

11AUG2021 (09:00 – 11:00 UTC -5)
Session 2: Polymers 101 and Mechanism of Leaching
Piet Christiaens

12AUG2021 (09:00 – 11:00 UTC -5)
Session 3: Analytical and Toxicology 101
Dries Cardoen and Kevin Breesch

Week 2

17AUG2021 (09:00 – 11:00 UTC -5)
Session 4: Do’s & Don’ts Extractables and Leachables
Dries Cardoen

18AUG2021 (09:00 – 11:00 UTC -5)
Session 5: Single Use Systems – Biodisposables and Simulation Studies LVP
Karen Pieters and Dennis Jenke

19AUG2021 (09:00 – 11:00 UTC -5)
Session 6: Small Volume Parenterals – Rubbers, Lyo Applications, Combination Products
Piet Christiaens

Highlighted Speakers

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

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 $299

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