Risk Management - A Process Flow Approach to Converting a Guidance into an SOP
Instructor:
David Husman
Product ID: 706414
Training Level: Intermediate
- Duration: 60 Min
Why Should You Attend:
To learn process flow approach that can be applied to any situation for creating effective standard operating procedures. This presentation utilizes ICH Q9 guidance as a vehicle for creating a Risk Management SOP.
When a new guidance or regulation is published, it is incumbent upon organizations to translate the guidance into system requirements, determine if processes exist, or implement new processes. This presentation will explore how to take a guidance that has been around for over a decade, but very few companies have effectively implemented into standard operating procedures (SOPs) - ICH Q9 – Risk Management guidance. This presentation will provide a process flow tool that results in effective SOPs.
Areas Covered in the Webinar:
- Capture Guidance Recommendations
- Process Flow Template
- Discuss Specific Process steps in each part of the Risk Management Process
- Initiate
- Access
- Review
- Control
- Discuss how to take process flow and create an Standard Operating Procedure
- Present sample SOP
Who Will Benefit:
- Quality Assurance Management
- Document Management
- Personnel responsible for creating Standard Operating Procedures
From Regulated industries – Pharma, Bio-pharma, Medical Device – all aspects from clinical to commercial.
Free Materials:
- Copy ICH Q9
- Process Flow Template
- Risk Management Standard Operating Procedure
David Husman
President and Principal Consultant, David Husman Consulting LLC
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