Product Details
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 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 report, we will cover:
- Achieving Compliance in Risk Management
- Applying various risk management tools
- Connecting ICH guidelines and quality risk management
- Assessing a quality risk management policy
- QRM Best Practices
- Program development and execution
- Understanding process, people and documentation
- Integrating QRM into Quality Systems
- Change control and investigations
- The benefits of integration
- Using Risk Management Tools
- Meeting regulatory requirements using these tools
- Options: process hazard analysis (PHA), risk evaluation and mitigation (REM), hazard analysis critical control point (HACCP) and FMEA
- Preparing for QRM Program Inspections
- 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.
About the Expert
Amanda McFarland, quality risk management and microbiology senior consultant at ValSource, assists companies with the design and implementation of CGMPs microbiology and quality risk management programs. She specializes in the creation and implementation of risk management programs, developing custom strategies and facilitation plans. She has a bachelor’s degree in entomology and a master’s degree in mycology, both from the University of Florida.
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
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Contributor:
Amanda McFarland
ISBN-13:
978-1-60430-149-6
Publication date:
Oct. 2020
Page count:
504
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