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Navigating the Intersection Between Regulatory Requirements & Risk Management Webinar August 5, 2021

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Pharmaceutical Quality Risk Management:

Navigating the Intersection Between Regulatory Requirements & Risk Management

An FDAnews Webinar

Thursday, Aug. 5, 2021, 1:30 p.m.-3:00 p.m. EDT

https://wcg.swoogo.com/pharmaceutical-quality-risk-management

How solid is one’s QRM?

The key to compliance in a world filled with increasing risk lies in quality risk management (QRM) principles and tools. But understanding the principles and how to apply them are not well-described in the regulations.

With many organizations making or having recently made decisions about how to maintain production levels given the pandemic, this webinar is a tremendous opportunity to explore the risks and apply risk-based decisionmaking to fully understand the long-term impacts.

Amanda McFarland, a QRM and microbiology senior consultant with ValSource, Inc., will clarify the regulations relative to risk management and how to apply the principles of QRM to do just that, sharing:


  • Best practices related to QRM program development and execution, including process, people and documentation

  • Ways to integrate QRM into quality systems such as change control and investigations and how integration can benefit your organization

  • The PIC/S Aide-Memoire on QRM and how one can prepare for a QRM program inspection

  • How to evaluate the risk management tools available to meet regulatory requirements, such as PHA, REM, HACCP and FMEA

  • Recognize the critical QRM regulations that apply to pharma such as ICH 9, ICH Q10, ISO 14644 and Annex 1

While risk is everywhere and ever-increasing, this webinar will enable attendees to use the principles of QRM and risk-based decisionmaking to ensure compliance going forward.

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:

Pharmaceutical Quality Risk Management:

Navigating the Intersection Between Regulatory Requirements & Risk Management

An FDAnews Webinar

Thursday, Aug. 5, 2021, 1:30 p.m.-3:00 p.m. EDT

https://wcg.swoogo.com/pharmaceutical-quality-risk-management

Tuition:

$297 per site

Easy Ways to Register:

Online: https://wcg.swoogo.com/pharmaceutical-quality-risk-management

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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