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On Demand PDA Webinar Extractable and Leachables for Parenteral Applications Series: Introduction, Helicopter View, and Setting the Stage

Online
  • Virtual
  • Webinar
  • 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 is part of the PDA Webinar: Extractables and Leachables for Parenteral Applications Series, which looks 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.

Highlighted Speakers

Dennis Jenke
Dennis Jenke
Triad Scientific Solutions

Who Should Attend

This webinar 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

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Registration Type Price
All Participants $99

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