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Supplier And Contract Manufacturer Management

Two focused days dedicated to equip professionals to make structured, risk-based supplier decisions that reduce audit burden, control quality outcomes, and align sourcing strategies with regulatory expectations across the supplier lifecycle. This Course is designed for professionals responsible for supplier oversight, quality agreements, or ensuring external partners consistently meet operational and compliance expectations.

COURSE INFO

08 - 09 June 2026
10 AM to 3 PM (Eastern Time - US/Canada)
3 PM to 8 PM (GMT)
** Registration to this course includes Trial access to TalkFDA Subscription and Members-only Community. Contact our Support for more details after the course completion.
  • Course Director
    John E. Lincoln
  • Course ID
    SEM3256
  • Live Session +
    Post-live Continued Learning
  • Live Q&A + Post Session
    Ask The Expert Included
  • Presentation Handout
    & Templates
  • Assessment &
    Certification Included

 

Why take this course?

Supplier and contract manufacturer decisions directly influence product quality, regulatory outcomes, and operational cost. Inconsistent qualification practices, weak agreements, or poorly monitored performance often lead to nonconformances, audit findings, and supply disruptions. Effective supplier management requires structured decision-making across sourcing, qualification, risk evaluation, and ongoing oversight, aligned with FDA, EU, and ISO expectations.

This program outlines a lifecycle-based approach—from supplier identification and selection through performance monitoring and transition planning. It connects strategic sourcing decisions, such as make-versus-buy and sole sourcing, with practical tools including risk assessments, supplier scorecards, and quality agreements. The focus remains on maintaining control over supplier processes, managing failures, and ensuring continuity while reducing unnecessary audit burden through informed, risk-based prioritization.

  • Supplier Decisions That Withstand Operational and Regulatory Scrutiny:

    Supplier-related failures often originate from weak qualification, unclear agreements, or inconsistent monitoring practices. This course strengthens decision-making across sourcing, risk ranking, and performance evaluation, enabling teams to reduce quality costs, respond effectively to regulatory expectations, and maintain control over outsourced processes without over-reliance on audits.

  • A Sequential, Lifecycle-Based Progression Across Two Days:

    The seminar builds from foundational concepts and regulatory expectations into strategic sourcing and risk-based qualification, then advances toward relationship management, performance monitoring, and transition handling. Each stage connects logically, reinforcing how early supplier decisions influence downstream control, enabling participants to apply a consistent lifecycle approach.

Key Areas Covered

  • Establishing supplier management programs aligned with FDA, EU directives, and ISO standards
  • Structuring make-versus-buy and sole sourcing decisions based on operational and cost considerations
  • Applying lifecycle-based risk assessment models to prioritize suppliers and reduce audit intensity
  • Designing qualification processes using structured data collection and selection tools
  • Developing quality agreements that define responsibilities, communication, and process control
  • Implementing supplier scorecards for performance tracking and decision-based evaluation
  • Managing nonconforming events, supplier-driven changes, and improvement initiatives
  • Selecting appropriate assessment methods including desktop reviews and on-site audits

Who Must Attend

  • Quality Assurance (QA) Departments
  • Quality Control (QC) Departments
  • Regulatory Affairs Departments
  • Supply Chain Management
  • Procurement and Sourcing
  • Manufacturing Departments
  • Operations Departments
  • Engineering Departments
  • Research & Development Departments
  • Laboratory Management Departments

Course Agenda

DAY 1

Foundations, Strategy, and Qualification

  • Core components and benefits of structured supplier management programs
  • Regulatory expectations across FDA, EU, and ISO frameworks
  • Cost implications of supplier-related quality issues and management alignment
  • Strategic sourcing decisions including make-versus-buy analysis
  • Lifecycle-based risk assessment and prioritization approaches
  • Supplier selection methods and qualification data requirements

DAY 2

Control, Monitoring, and Transition Management

  • Building and maintaining effective supplier and contract manufacturer relationships
  • Developing and applying practical quality agreement structures
  • Implementing supplier performance monitoring using scorecards
  • Managing nonconforming events and driving supplier improvement actions
  • Selecting and applying desktop assessments versus supplier audits
  • Handling supplier transitions while maintaining continuity and control
COURSE DIRECTOR

John E. Lincoln

John E. Lincoln brings over four decades of experience in FDA-regulated industries, with deep involvement in quality systems, regulatory affairs, and supplier-related compliance. His work spans supplier oversight, QMS remediation, risk management, and audit readiness, making him well-positioned to guide structured supplier management practices across complex, regulated environments.

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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.

Your TalkFDA Webinar Experience

When you reserve your seat, everything is organized for you — from access to certification from one place.

1. Confirmation
You receive a confirmation email and your course appears instantly in your TalkFDA dashboard.

2. Your Course Hub
Your TalkFDA course page becomes your central hub where you can join the session, access materials, and manage your learning.

3. Join the Live Training
At the scheduled time, click Join Session and you’ll be connected to the live Webex session with the instructor.

4. Watch Again Anytime
After the session, the playback becomes available on the same course page so you can revisit important sections.
5. Earn Your Certificate
Complete the course and your certificate is unlocked automatically in your learning history.

Everything related to your webinar: access, materials, playback, and certification — lives in one place.
Simple. Organized. Professional.
Go ahead and reserve your seat with confidence.

Supplier And Contract Manufacturer Management

Dates: 08 - 09 June 2026

REGISTRATION OPTIONS

  • Live Session
  • Complimentary Streaming Access
  • Ask the expert
  • Assessment & Certification
  • Trial access to TalkFDA Membership
SINGLE ACCESS
FOR 1 ATTENDEE
$1800

$1200

  • 2 Days - Live
  • 30 Days post-live Continued Learning
  • Included
  • Included
  • Included
GROUP ACCESS
2 - 5 ATTENDEES
$4000

$2700

  • 2 Days - Live
  • 30 Days post-live Continued Learning
  • Included
  • Included
  • Included
CORPORATE ACCESS
6 - 10 ATTENDEES
$8300

$4500

  • 2 Days - Live
  • 30 Days post-live Continued Learning
  • Included
  • Included
  • Included
IN-HOUSE TRAINING
Via TalkFDA Elite Training Labs

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Upcoming Courses

Testimonials

This is an upcoming session. Feedback below reflects experiences from similar programs delivered by our expert faculty.

“Session was easy to follow even for non-core team members. That helped.”
- Production Officer
“Good balance. Not too basic, not too deep. Worked well for mixed team.”
- Manager, Regulatory Affairs
“Team found it useful. Especially for aligning understanding across functions.”
- Director, Operations

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