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A to Z of Supplier Management in the Medical Device Industry

This course strengthens the ability to qualify, audit, monitor, and control medical device suppliers under FDA QSR and ISO 13485 expectations. It helps professionals reduce supplier-related compliance exposure through structured oversight, audit planning, process controls, and supplier corrective action management. This Course is designed for professionals responsible for supplier oversight, quality compliance, manufacturing controls, and external partner management.

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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 : Meena Chettiar
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2674
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Supplier management directly affects product quality, regulatory compliance, and manufacturing continuity in the medical device industry. FDA expectations for supplier oversight, supplier audits, and OEM management continue to increase, placing greater responsibility on organizations to maintain documented control over qualification, monitoring, corrective actions, and supplier performance. Quality System Regulation requirements and ISO 13485 obligations make supplier management a critical operational function rather than an administrative activity.


Effective supplier oversight requires consistent evaluation methods, audit planning, process capability assessment, and alignment between supplier controls and product quality expectations. This course addresses qualification criteria tied to quality systems, product development processes, ISO certifications, and supplier manufacturing quality plans. It also addresses supplier audit frequency, SCAR follow-up activities, statistical process control considerations, first article inspection requirements, supplier training expectations, and regulatory obligations associated with supplier changes in medical device operations.

  • Strengthen Supplier Oversight and Audit Readiness:

    Participants gain practical direction for qualifying and sustaining suppliers while meeting FDA and ISO 13485 expectations. The course clarifies supplier audit frequency decisions, SCAR follow-up requirements, and documentation practices that support inspection readiness. Greater scrutiny on OEMs and external providers makes consistent supplier controls increasingly important for maintaining compliance and product quality.

  • Improve Process Control and Supplier Quality Decisions:

    The course connects supplier quality activities with manufacturing capability, SPC expectations, CTQ criteria, and first article inspection requirements. Participants develop stronger judgment for assessing supplier process controls, manufacturing quality plans, and sample inspection capability. It also clarifies the supplier quality role in new product release authorization and managing supplier-driven regulatory changes.

Key Areas Covered

  • Supplier qualification criteria based on quality systems, product development processes, ISO certifications, and regulatory requirements
  • FDA Quality System Regulation (QSR) and ISO 13485 expectations for supplier management and OEM oversight
  • Supplier onboarding, sustaining activities, and supplier training aligned with quality expectations
  • Supplier audits, audit frequency criteria, audit reporting, and SCAR follow-up activities
  • First article inspection, SPC correlation, CTQ and CTC criteria, and supplier process capability assessment
  • Supplier process control methods and capability assessment for sample inspections
  • Supplier quality responsibilities for new product release authorization and supplier manufacturing quality plans
  • Oversight considerations for testing laboratories, sterilization facilities, and supplier-related regulatory changes

Who Must Attend

  • QA/QC Departments
  • Regulatory Affairs Departments
  • Manufacturing  Departments
  • Engineering  Departments
  • Supplier Quality and Audit Teams
  • Supply Chain Department 

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

MEENA CHETTIAR

Meena Chettiar is a Quality and Regulatory Manager with experience across pharmaceutical, medical device, and regulated manufacturing environments. Her background includes supplier auditing, CAPA coordination, GMP compliance, and quality system implementation at organizations including Covidien, Baxter Bio Surgery, and Teva Pharmaceuticals. She has served as a lead supplier and internal auditor in domestic and international compliance audits and teaches ASQ certification courses related to biomedical auditing, quality auditing, and organizational excellence.

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