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Risk Management and Impact Assessments in Change Control

This course provides practical methods for evaluating change impact, integrating risk-based decision making, and strengthening change control procedures to reduce product, regulatory, and cross-functional operational exposure in regulated pharmaceutical and medical device environments. This Course is designed for professionals responsible for regulated product changes, quality oversight, compliance decisions, and operational controls.

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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 : Alan M. Golden
  • Study time : 60 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3592
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Change control failures remain a common concern during regulatory audits and product nonconformance investigations within pharmaceutical and medical device operations. Changes made without sufficient impact assessment or risk evaluation can negatively affect product performance, compromise validation activities, or unintentionally influence related products and processes. Effective change management requires structured assessment methods that support informed implementation decisions and appropriate verification activities.


This course focuses on the operational role of impact assessments within the broader change control process and the importance of integrating risk management before, during, and after a change is introduced. Particular attention is given to defining low-impact changes, establishing practical internal procedures, and developing decision-making tools that guide consistent assessments. The session also addresses the formation of assessment teams, the use of change control roadmaps, and the importance of documenting justification decisions that support regulatory expectations and internal quality system requirements.

  • Build More Reliable Change Assessment Decisions:

    Participants will gain practical approaches for evaluating the operational and regulatory impact of proposed changes before implementation. The course clarifies how impact assessments support justification decisions, verification activities, and validation requirements while reducing the likelihood of overlooked product risks, ineffective documentation practices, or audit observations tied to inadequate change evaluations.

  • Strengthen Risk-Based Change Control Procedures:

    The session provides structured methods for incorporating risk management into routine change control activities using practical assessment tools, decision trees, and defined review processes. Organizations operating in regulated environments face increasing scrutiny around change documentation and cross-functional impact evaluation, making consistent internal procedures essential for maintaining product quality and compliance expectations.

Key Areas Covered

  • The operational role of impact assessments within the change control process
  • Regulatory expectations for reviewing, verifying, and validating changes as appropriate
  • Structuring change descriptions, justification requirements, and supporting documentation
  • Defining and managing low-impact changes within internal SOP requirements
  • Building and organizing impact assessment teams for change evaluation activities
  • Developing change control roadmaps using forms, decision trees, and assessment records
  • Integrating risk management considerations before, during, and after change implementation
  • Understanding regulatory and cross-product operational impact during change execution

Who Must Attend

  • QA/QC Departments
  • Regulatory Affairs Teams
  • R&D Teams
  • Manufacturing, Engineering & Operations
  • Production & Validation Professionals
  • GMP Trainers & Auditors
  • Consultants

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

ALAN M. GOLDEN

Alan has more than 30 years of medical device industry experience spanning research, quality assurance, and regulated product support. During his tenure at Abbott Laboratories, he held quality assurance responsibilities involving design control, change control, risk management, CAPA, validation, and quality systems oversight across development and operations. His experience includes implementing and supporting controlled change processes within regulated environments, along with delivering global training programs focused on quality assurance and compliance-related practices.

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“Some parts we already knew, but the way it was explained made it easier to apply. We ended up revisiting our internal approach after this.”

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