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The Controls for Outsourcing Manufacturing and Testing - By Compliance Global Inc.


  • The Controls for Outsourcing Manufacturing and Testing

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About The Event

Speaker: Howard T Cooper


"The Controls for Outsourcing Manufacturing and Testing" explores the use of outsourcing and how it impacts quality and compliance and the organization as a whole. The primary stakeholders and outsourcing include Quality, Research, Production, Laboratories, Purchasing/Procurement, Finance, and Senior Management.

This webinar will study the outsourcing lifecycle and its impact on the organization. Although outsourcing as a whole will be studied, the emphasis will be on contracting manufacturing, design, and testing.

The webinar will begin with a brief review about the importance of quality systems and their role in maintaining the organization. Outsourcing will be defined and examples throughout the FDA approved industry will be discussed. Of course, regulatory compliance requirements will be discussed to include the FDA's current thinking about the required controls. Particular emphasis will be given on the importance of understanding the differences between contractors and suppliers.

The process of auditing and qualifying contractors and assuring compliance quality goals are maintained, will be explained.

Why Should You Attend

This webinar will help you understand your responsibilities when outsourcing so that the product maintains its integrity and quality and satisfies customer and user requirements. 

The FDA is closely scrutinizing these activities to assure that responsibilities outlined in the regulations and guidance is clearly defined between the contractor and its client. 

These industry requirements are given in CFR Part 211.22(a), ICH Q7A 2.22-8, ICH Q7A 16, ICH-Q10 and Part 820, Subpart E.

The FDA has begun to more closely scrutinize the control of outsourcing because they have observed a frequent pattern where the firms allow contractors to completely control QA responsibilities.

Areas Covered in this Webinar

  • The Resourcing Lifecycle
  • The Quality Agreement-Defined Responsibilities
  • Design and Change Control
  • Maintaining Control and Problem solving
  • Post-approval aspects of Outsourcing
  • Quality Improvement and Resourcing
  • Covering the loopholes

Learning Objectives

  • Defining and Analyzing the Outsourcing Environment
  • Regulatory Requirements For Outsourcing - Drugs & Devices
  • Outsourcing Management

Who Will Benefit

  • Regulatory Affairs Personnel
  • Purchasing, Procurement, Outsourcing Department Staff
  • R&D Professionals 
  • Quality Professionals
  • Senior Management



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