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
Attend this webinar to learn how to translate a new guidance or regulation into a working process, and how to use process flow, techniques and templates to develop procedures on your own. The webinar will provide you with a working SOP for Risk Management.
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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
Instructor Profile:
David Husman

David Husman
President and Principal Consultant, David Husman Consulting LLC
  • Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 18 years as a consultant to biopharma, pharma and device industries.
  • Experience has spanned from R&D to Commercial Manufacture
  • Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.
  • Extensive experience in laboratory operations including but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations.
  • Experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control.
  • Expert level in Compliance and Quality System development.
  • Executed numerous Data Integrity assessments and remediation projects worldwide.
  • Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs.
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