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FDA Efforts at Global Harmonization Management Report

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Protecting the Pharma Supply Chain:

FDA Efforts at Global Harmonization

FDAnews Management Report

https://www.fdanews.com/products/61596

Ready to comply with FDA’s new push to tighten its control of the global supply chain?

Recent cooperation in inspections … regulator focus on global supply chains … and increased harmonization efforts … although borne of the pandemic, they show no signs of stopping.

Protecting the Pharma Supply Chain: FDA Efforts at Global Harmonization explains the changes so one can pivot accordingly and comply with stricter quality standards, new supply chain rules, enhanced quality manufacturing metrics and much more.

While harmonizing good manufacturing practice (GMP) regulations across borders and instituting more information-sharing between U.S. regulators and others will prevent the kinds of drug shortages and reduced quality brought about by the pandemic, it means additional burdens on pharmaceutical companies.

Based on a webinar by Howard Sklamberg, partner at Arnold & Palmer and former FDA deputy commissioner for global regulatory operations and policy, Protecting the Pharma Supply Chain explains:


  • The future of the U.S.-EU Mutual Recognition Agreement and what it means for inspections

  • The long-lasting effects of FDA guidance on inspection alternatives during the pandemic — will these reforms continue?

  • How the CARES Act provisions on the supply chain will affect harmonization and how companies should prepare

  • The effect of pharmaceutical onshoring initiatives in the U.S. and Europe on harmonization efforts and what that means for manufacturers

  • How to prepare for the FDA’s ongoing quality metrics initiative.

Strengthen supply chain, bolster quality and ensure compliance with Protecting the Pharma Supply Chain: FDA Efforts at Global Harmonization.

Management Report Details:

Protecting the Pharma Supply Chain:

FDA Efforts at Global Harmonization

FDAnews Management Report

https://www.fdanews.com/products/61596

Price:

$397

Easy Ways to Register:

Online: https://www.fdanews.com/products/61596

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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