GMP Change Control Process


Duration: 12 Hours
Course Instructor

Louis Angelucci

$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

Change control is a requirement of all regulatory agencies and authorities worldwide. It is a critical GMP function that must be addressed daily. The value of identifying and tracking change is to prevent unintended consequences, remain in proper process alignment, and avoid any alteration of the products’ Safety, Identity, Strength, Purity, and Quality (SISPQ). Many aspects of an operation are affected by change control, making it imperative to properly assess, analyze, risk assess, and plan for the change requested as part of the change control process.

This accredited course will provide an in-depth examination of what constitutes a change, who is responsible, and who participates in each step of the process. This course also covers the US FDA terms and exclusions regarding change control that have been implemented over the past few years.

Included in this course will be LIVE change control exercises so that the participants can practice identifying and implementing knowledge learned in real-time with our subject matter expert.

Upon completion of this course, you will be able to:

  • Define and explain Change Control and the process
  • Identify and show what to do when change occurs
  • Outline the requirements of Change Control including verification
  • Utilize the appropriate process in initiation, follow through, and closure of a change
  • Review and discuss examples of Change Control
  • Develop a Change plan
  • Plan and utilize the Change Control process and associated documentation
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This course has been developed to meet the training needs of both beginners and experienced professionals involved in Quality Assurance/Quality Control, Regulatory Affairs, Development, and Manufacturing that participate in change control processes within the following industries:

  • Pharmaceutical Science
  • Biologics
  • Research & Development
  • Medical Device
  • Cosmetics
  • Veterinary Drug Products

Course Instructor


Louis Angelucci

Consultant for the Pharmaceutical Industry

Louis Angelucci’s Courses


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