LIVE WEBINAR

WEBINAR - INSTANT STREAMING ACCESS

Contract Manufacturing: The CMO Supplier Agreement
– How to Comply with FDA and EU Regulatory guidelines

  • Charles H. Paul
  • FDB3767
  • Charles H. Paul
  • FDB3767
  • 90 Minutes Learning Time
This course equips teams to structure and manage CMO Supplier Agreements that clearly define responsibilities, audit expectations, and change control while aligning with FDA and European regulatory requirements, helping reduce compliance gaps and improve coordination across contract manufacturing relationships.
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REGISTER: CHOOSE YOUR ACCESS OPTION

ONE participant (viewer) – Live session Plus Complimentary 30 Days Streaming access

Up to 10 participants – Live session Plus Complimentary 30 Days Streaming access

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Why take this course?

Contract manufacturing places regulatory responsibility across multiple organizations, making clarity of roles, documentation, and oversight essential. FDA and European requirements expect that product quality, patient safety, and compliance are maintained regardless of who performs the manufacturing activity. This creates direct dependence on well-defined agreements, quality systems, and inspection readiness across both the sponsor and the contract manufacturer.

This program focuses on how regulatory expectations are translated into a structured CMO Supplier Agreement and supporting quality system controls. It addresses FDA cGMP requirements alongside European expectations such as EMA guidelines, MDR considerations, and CE marking obligations. Attention is given to how agreements define responsibilities, manage audits and change control, and support documentation, data integrity, and inspection readiness across contract manufacturing relationships.

  • Define responsibilities clearly across contract manufacturing:

    Contract manufacturing often weakens when roles between sponsor and manufacturer are not clearly documented. This course strengthens how responsibilities for quality, manufacturing, and regulatory compliance are assigned and maintained within agreements, helping reduce gaps that may surface during inspections or impact product quality and release decisions.

  • Strengthen audit, change control, and agreement execution:

    Regulatory expectations require consistent oversight of contract manufacturers through audits, change control, and notification processes. This course improves how teams structure these elements within supplier agreements and align them with operational practice, supporting more predictable execution when regulators review how external partners are managed.


Key Areas Covered

  • FDA regulatory framework for contract manufacturing, including cGMP requirements and facility expectations
  • European regulatory environment including EMA guidelines, MDR considerations, and CE marking
  • Purpose and structure of the CMO Supplier Agreement
  • Key agreement components including quality standards, responsibilities, and compliance procedures
  • Auditing processes, change control mechanisms, and notification requirements
  • Quality Management System expectations, documentation practices, and data integrity considerations
  • Preparing for regulatory audits and inspections and understanding areas of focus
  • Responding to audit observations and inspection findings

This Course is designed for professionals responsible for managing external manufacturing relationships, supplier oversight, or ensuring compliant execution across outsourced production activities


A must for QA/QC, Regulatory Affairs, Manufacturing, Operations, Supply Chain and Procurement, and Contract Management Teams.

COURSE DIRECTOR

Charles H. Paul

Charles H. Paul has over 25 years of experience leading a regulatory, training, and technical documentation consulting firm supporting pharmaceutical, medical device, and biotechnology companies. His work focuses on regulatory compliance, documentation systems, and operational practices, aligning directly with structuring CMO Supplier Agreements, managing audits, and maintaining compliant contract manufacturing relationships across global 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.

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