FDAnews Announces — Drug Shortages and cGMP/Quality: An Interview with CDER Deputy Director Dr. Douglas C. Throckmorton Webinar, Mar. 18, 2020

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Want to improve product quality to prevent drug shortages? Former FDA Associate Commissioner interviews CDER Deputy Director for insights and agency plans.

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WCG FDANews

Drug Shortages and cGMP/Quality:
An Interview with CDER Deputy Director Dr. Douglas C. Throckmorton
An FDAnews Webinar
Wednesday, March 18, 2020, 2:00-3:00 p.m. EDT
https://www.fdanews.com/drugshortages

How will the Center for Drug Evaluation and Research (CDER) approach the challenges in assessing quality management maturity?

What are CDER’s plans to handle transparency across the supply chain?

How will CDER address the lack of market reinforcement of effective quality management maturity?

What can one do to help prevent quality related drug shortages?

Learn the answers to these questions and more during an exclusive interview:

Douglas C. Throckmorton, MD, CDER’s Deputy Director for Regulatory Programs, will be interviewed by Peter Pitts, former FDA Associate Commissioner and current President of the Center for Medicine in the Public Interest.

Dr. Throckmorton will also discuss CDER’s steps regarding its two most important 2020 initiatives: drug shortages and pharmaceutical current good manufacturing practices (cGMP)/quality. Discover how these two interrelated issues facing CDER relate to quality and drug shortages challenges in 2020 and beyond.

Dr. Throckmorton and Mr. Pitts will reveal the actions one can take to prevent drug shortages by promoting and sustaining quality manufacturing:

  • How the FDA is implementing its landmark report on the topic — Drug Shortages: Root Causes and Potential Solutions
  • How the FDA is interacting with drug manufacturers to alleviate the drug shortage situation
  • The pivotal role manufacturers can play in assessing potential threats to quality and in taking proactive remediation in areas such as facility redundancy
  • The crucial role that data and transparency play in quality issues affecting drug shortages
  • How the FDA is currently administering the requirements to be followed by drug manufacturers for good manufacturing practices in manufacturing, processing, packaging and holding of drugs under 21 CFR Part 210
  • How drug manufacturers can stay in compliance with FDA regulations on cGMP quality

Bolster pharmaceutical cGMP/quality and avoid drug shortages. Don’t miss this opportunity to hear directly from CDER’s Deputy Director and a former FDA Associate Commissioner on two of the agency’s most important 2020 initiatives.

Interested in registering multiple sites?
Call 888.838.5578 in the U.S. or +1 703.538.7600 globally to learn about our special multisite discount.

Webinar Details:
Drug Shortages and cGMP/Quality:
An Interview with CDER Deputy Director Dr. Douglas C. Throckmorton
An FDAnews Webinar
Wednesday, March 18, 2020, 2:00-3:00 p.m. EDT
https://www.fdanews.com/drugshortages

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/drugshortages
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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Michelle Butler
FDAnews
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