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Practical Implementation Of Pharmaceutical Quality Risk Management (QRM)

This course equips pharmaceutical professionals to apply Quality Risk Management principles consistently across quality processes, improving risk-based decision making through structured evaluation of severity, occurrence, and detectability while reducing confusion around QRM implementation and tool selection. This Course is designed for professionals responsible for pharmaceutical quality processes, risk evaluation, compliance, and operational decision making.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Steven Laurenz
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2302
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Quality Risk Management remains a central expectation within pharmaceutical quality systems, particularly under ICH Q10, yet many organizations continue to struggle with consistent implementation across routine quality activities. Confusion often arises when risk management is treated only as an individual assessment tool rather than a structured process supporting scientifically based quality decisions. Clear understanding of severity, occurrence, detectability, and overall risk evaluation is necessary for reliable decision making and effective control of quality-related issues.

The course establishes practical understanding of core QRM terminology, the four primary components of Quality Risk Management, and the application of commonly used risk management tools within pharmaceutical operations. Attention is given to how risk levels are defined and interpreted, allowing professionals to apply QRM principles more consistently within existing quality processes. The material also clarifies the relationship between formal risk tools and broader QRM expectations within an effective pharmaceutical quality system.
  • Consistent Risk-Based Quality Decisions:

    Organizations frequently apply risk tools inconsistently because the underlying QRM process is not clearly understood. This course strengthens the ability to assess severity, occurrence, and detectability within a structured decision process, helping teams support quality actions with clearer rationale and better alignment to pharmaceutical quality system expectations, including principles referenced in ICH Q10.

  • Clearer Application of QRM Tools:

    Many pharmaceutical organizations struggle to distinguish between individual risk assessment tools and a complete Quality Risk Management approach. The course clarifies key terminology, core QRM components, and practical application of risk tools, supporting more consistent quality process execution and reducing operational uncertainty during risk evaluation and quality-related decision activities.

Key Areas Covered

  • Core terminology associated with pharmaceutical Quality Risk Management
  • The four primary components of an effective QRM process
  • Risk evaluation using severity, occurrence, and detectability criteria
  • Application of QRM principles within pharmaceutical quality processes
  • Examples of risk management tools and appropriate operational use
  • Relationship between QRM implementation and ICH Q10 pharmaceutical quality system expectations

Who Must Attend

  • Process Owners
  • Quality Auditors & Engineers
  • Quality & Compliance Professionals
  • Production Engineers & Supervisors
  • Senior Quality Managers
  • Regulatory Professionals
  • Manufacturing Engineers
  • Development Professionals & Managers

Quality training, expert insights, and answers that matter. Know your Expert

STEVEN LAURENZ

Steven Laurenz is Principal Consultant at BioPhia Consulting Inc. with more than 25 years of experience across product development, process development, technology transfer, and pharmaceutical quality systems. His work has included integrating Quality by Design and risk management into product development activities and establishing quality systems for R&D Quality Assurance organizations. He previously led product development functions at Abbott Laboratories and AbbVie Inc. and holds an M.S. in Chemical Engineering from Michigan State University.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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“Presenter didn’t overcomplicate things. Kept it moving. That helped keep the team engaged.”


Director, Manufacturing

“Some good points came up during Q&A. That part was useful for us.”

Auditor, Compliance

“Length was fine. Could sit through without losing focus.”


Supervisor, Manufacturing

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