FDAnews Announces — Pharmaceutical Quality Risk Management: Navigating the Intersection Between Regulatory Requirements & Risk Management Webinar July 29, 2020

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Increased risk? Strengthen one’s quality risk management — consistently apply appropriate principles and tools to stay compliant.

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Pharmaceutical Quality Risk Management
Navigating the Intersection Between Regulatory Requirements & Risk Management
An FDAnews Webinar
Wednesday, July 29, 2020, 11:00 a.m.-12:30 p.m. EDT
https://www.fdanews.com/pharmaqrk

Risk is everywhere. And growing. Struggling to manage the types — and severity — of risk with Quality Risk Management (QRM) techniques?

QRM must be applied consistently to an ever-increasing roster of drug development, manufacturing, distribution, and inspection and submissions review processes. If one is exerting a huge effort but still feels adrift, this webinar is the answer.

Amanda McFarland, a QRM and microbiology senior consultant with ValSource, Inc., will explain the regulations relative to risk management and explain how to apply QRM’s principles to achieve compliance and maintain a competitive advantage. She will:

  • Discuss best practices related to QRM program development and execution, including process, people and documentation
  • Demonstrate ways to integrate QRM into quality systems such as change control and investigations and how integration can benefit an organization
  • Explore the PIC/S Aide-Memoire on QRM and how one can prepare for an inspection of a QRM program
  • Evaluate the risk management tools available to meet regulatory requirements, such as process hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP), and failure mode and effects analysis (FMEA)
  • Recognize the critical QRM regulations that apply to pharma such as ICH 9, ICH Q10, ISO 14644 and Annex 1

Given that organizations have made or are currently making decisions about how to maintain production levels in light of the novel coronavirus, this is an incredible opportunity: Ms. McFarland will assist one in exploring the risks and applying risk-based decisionmaking to ensure the long-term impacts of a company’s current decisions are fully understood.

Come away with the tools needed to ensure the QRM works to keep one compliant and moving 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
Wednesday, July 29, 2020, 11:00 a.m.-12:30 p.m. EDT
https://www.fdanews.com/pharmaqrk

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/pharmaqrk
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
703.538.7600
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