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On Demand PDA Webinar: Mitigating Shortages of Critical Manufacturing Supplies During a Global Pandemic

Online
  • Virtual
  • Webinar
  • Online

Overview

This on demand webinar rebroadcast is free to all who register.

The COVID-19 pandemic has put an immense strain on the biopharmaceutical industry to continue to deliver life-saving medical products to the global population. Maintaining availability of consumable supplies critical to processing has been especially challenging for manufacturing sites. The purpose of this on demand webinar is to understand the impact of these shortages, potential mitigations, best practices in working with vendors, effectively managing and documenting changes, and regulator expectations. Future opportunities for streamlined regulatory pathways, creating supply chain flexibility and sustainability all with the goal to maintain patient access to critical therapeutic products will also be explored.

Agenda

  • General areas that will be covered:

    • Overview of the magnitude and impact of manufacturing and laboratory consumable shortages, including the review of a benchmarking survey completed by Chief Quality Officers (via PwC) from some of the top pharmaceutical companies
    • An end-user perspective on the current impact of COVID-19 on material supply and potential mitigation strategies
    • Case Study: Focus on process change to mitigate a shortage of filters, including technical risk assessment and related post approval change considerations
    • Potential strategies to reduce regulatory barriers to needed post approval changes

Highlighted Speakers

Denyse D. Baker
Denyse D. Baker
AstraZeneca
Mark Birse
Mark Birse
Parexel
Cathy Hoath
Cathy Hoath
Merck
Maik W. Jornitz
Maik W. Jornitz
G-CON Manufacturing Inc
Niraj Mehta
Niraj Mehta
Merck
Morten Munk
Morten Munk
Fujifilm Diosynth Biotechnologies
CDR Emily T. Thakur
CDR Emily T. Thakur
U.S. FDA

Who Should Attend

This on demand webinar is intended for professionals who work in the following departments:

  • Quality Systems
  • Quality Compliance
  • Manufacturing
  • Quality Assurance Operations
  • Research and Development
  • Regulatory Affairs
  • Technical Operations
  • Supply Chain

Registration Fees

Register Now

This on demand webinar rebroadcast is free to all who register.

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