Pharmaceutical Quality Risk Management: Navigating New Regulatory Requirements

Kelly Thomas

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The COVID-19 pandemic is making it more difficult for pharmaceutical manufacturers to maintain production levels and meet regulatory requirements. As a result, the need for effective quality risk management (QRM) tools and programming has risen dramatically.

One way to ensure your products satisfy expectations is to develop an outstanding QRM system and stick to it.

Whether this is a new undertaking or you’re updating your current system our webinar Pharmaceutical Quality Risk Management: Navigating New Regulatory Requirements will guide you through determining which risks you need to manage, how to consistently apply risk management principles and ways to build an effective QRM plan. By using our expert tips, you can apply risk-based strategies to ensure that the long-term impacts of your company’s current decisions are fully understood.

In this webinar, we will cover:

  • Achieving Compliance in Risk Management
    1. Applying various risk management tools
    2. Connecting ICH guidelines and quality risk management
    3. Assessing a quality risk management policy


  • QRM Best Practices
    1. Program development and execution
    2. Understanding process, people and documentation


  • Integrating QRM into Quality Systems
    1. Change control and investigations
    2. The benefits of integration


  • Using Risk Management Tools
    1. Meeting regulatory requirements using these tools
    2. Options: process hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP) and FMEA


  • Preparing for QRM Program Inspections
    1. Critical quality risk management regulations, including ICH 9, ICH Q10, ISO 14644 and Annex 1

Quality risk management is an essential component of any successful pharmaceutical endeavor. With the complications of the current global health crisis, QRM is even more critical.

Don’t miss this opportunity to develop the most effective quality risk management program.


Who Will Benefit

  • Drug development companies
  • QA/QC personnel
  • R&D managers
  • Compliance officers
  • Executive managers
  • Risk management specialists
  • Regulatory and legislative professionals
  • Manufacturing directors and supervisors


Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Kelly Thomas, Vice President, Americas Quality Operations

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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