Equipment and Process Change Control - Webinar CD/Transcript
Equipment and Process Change Control: Manage Changes Correctly and Efficiently
Equipment and process change control is a collection of formal, documented procedures that are used to request, assess, review and formally authorize a change to process, equipment or project. Requirements for such change control are codified in federal law and FDA guidance. This fundamental topic for regulated manufacturing can be complex to the point of utter confusion.
This presentation will break it down and tell you exactly what you need to know to stay compliant and it will help you ensure that when you make changes to your processes or equipment, nothing goes wrong.
Industry expert Vadim Klyushnichenko, Ph.D. will take you through the relevant sections of 21 CFR Subpart F, through a change control flow sheet, and discuss strategies for process development.
He’ll explore what process characterization is, define process parameters and help you determine which are critical and which aren’t.
He’ll talk about how change control applies to transitions such as going from IND to NDA, scaling up or down, or between old manufacturing technologies and new.
Finally, he’ll explore a pair of detailed case studies in change control to show you exactly how these principles work in the real world.
This presentation will teach you:
- The definitions and explanations of a change control system in the biopharmaceutical industry
- What the regulatory requirements for change control are
- What the current process development strategy in the biopharmaceutical industry is and how change control is applied to different phases of drug development and manufacturing
- How to characterize process and define critical process parameters
- What kind of technology transfer strategies are applicable for the biopharmaceutical industry
- Equipment and process qualification and validation as a final step of equipment change control
- Practical examples of equipment and process changes