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A. Burak Ucar, Ph.D
Subject Matter Expert

Procedure for Manufacturing Control Strategy Using Quality-by-Design (QbD) Principles

Guidance on Development, Implementation, and Maintenance
Product Description

The FDA and EMA require biopharma and device manufacturers to have a formal strategy for controlling quality in manufacturing – yet few organizations have written procedures to follow. By purchasing this SOP, you will have the tools to develop, implement, and maintain an effective QbD control strategy for late-stage product development and commercial manufacturing. This SOP can be applied to new or existing products and can help you maintain compliance with 21 CFR  Parts 210, 211, and/or 820 Subpart G.

This product addresses the folllowing key concepts:

  • Roles and Responsibilities
  • QbD and Control Strategy Relationship
  • Control Strategy Elements
  • CQA / (Critical) Process Parameter Identification and Classification
  • Design Space and Process Controls
  • Control Strategy Documentation
  • Lifecycle Management
Purchase Price   $0 $399
Short Summary Presentation (6 slides) PDF yes yes
Editable SOP (25 Pages) Word no yes
Editable Presentation with suggested script (50 slides) Powerpoint no yes