COURSE - INSTANT STREAMING ACCESS
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Impact Assessments for Supplier Change Notices

This course strengthens the ability to evaluate supplier-driven material, production, and location changes before implementation, reducing operational and regulatory exposure. Participants will improve decision-making around supplier notifications, risk prioritization, and change acceptability within controlled pharmaceutical and medical device supply chains. This Course is designed for professionals responsible for supplier oversight, regulated manufacturing changes, product quality, and compliance decisions.

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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: TF3591
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Supplier-driven changes to materials, manufacturing processes, or production locations can directly affect product quality, manufacturing performance, and regulatory obligations within pharmaceutical and medical device operations. Regulatory agencies expect manufacturers to maintain effective oversight of suppliers and demonstrate that changes introduced within the supply chain are appropriately assessed before implementation. Weak supplier communication practices or inadequate impact evaluations can create inspection concerns, product variability, and operational disruption.


This course addresses the practical assessment of supplier change notices, including the role of supplier agreements, continuing guarantee statements, and structured review procedures. Attention is given to triage methods, team-based evaluations, and distinguishing low or no impact changes from those requiring full assessment activities. The course also discusses determining acceptable changes, applying risk-based levels of work, and responding appropriately when proposed supplier changes cannot be accepted.

  • Strengthen Supplier Change Evaluation Practices:

    Participants will improve their ability to assess supplier notifications involving material, production, or location changes before those changes affect manufacturing operations. The course clarifies how structured procedures, triage activities, and risk-based review approaches support consistent decisions that align with FDA and ISO expectations for supplier oversight and supply chain control.

  • Improve Change Acceptance and Risk Decisions:

    The course provides practical direction for distinguishing low or no impact supplier changes from changes requiring expanded assessment activities. Participants will gain greater confidence in organizing review teams, applying appropriate levels of evaluation work, and determining whether proposed supplier changes can be accepted without creating unnecessary operational or regulatory exposure.

Key Areas Covered

  • Regulatory expectations for supplier oversight within pharmaceutical and medical device manufacturing
  • FDA and ISO considerations related to supplier change management and supply chain control
  • Supplier agreements, continuing guarantee statements, and change notification requirements
  • Procedures, triage activities, and team involvement in supplier change notice assessments
  • Determining low or no impact changes versus changes requiring full impact assessments
  • Risk-based evaluation methods and determining the acceptability of supplier-driven changes

Who Must Attend

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Production Departments
  • Supply Chain Departments
  • Technical Scientists

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

ALAN M. GOLDEN

Alan has more than 30 years of experience in the medical device industry spanning research, quality assurance, and regulated product operations. During his time at Abbott Laboratories, he worked in diagnostics research and later held quality assurance responsibilities supporting new product development, on-market products, and operations. His experience includes change control, risk management, CAPA, validation, and supplier-related quality activities directly connected to evaluating operational and regulatory impact from supplier changes.

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“Support team was quite responsive before the session. That made it easier to get aligned internally. Presenter kept things simple, not overloaded.”

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“Pre-session communication was smooth. No confusion on access or timing.”


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