In partnership with NUS
Academy of GxP Excellence since 2009
As a critical component to a compliant validation program, this course provides an overview of principles and regulatory requirements behind cleaning validation. More specifically, this course will address cleaning validation in pharmaceutical plants.
Both the theoretical basis and practical applications of the validation process will be discussed. Some of the more common mathematical and statistical treatments of validation data will be presented. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions and case studies.
This course provides participants with an understanding of the essential steps for the proper design and integration of pharmaceutical process and cleaning validation for API products. It includes how to establish proper design criteria and specifications to form the basis of process and cleaning validation design and compliance elements required for international cGMP compliance.
• Cleaning Validation Basics
• Elements of a Cleaning Validation Program
• Specific cleaning aspects of typical API processes
• Strategies and Approaches for Cleaning Validation
• Sampling Techniques and Methodology
• Cleaning and Sanitizing Agents and Methods
• How to Establish an Acceptable Residue Limit
• Cleaning Validation - Microbial Control
• Post Validation Monitoring of Cleaning Process
• Regulatory concerns and requirements
Upon completion of this course the attendees will be able to:
1. Gain an understanding of the principles of cleaning validation
2. Gain an understanding of current regulatory perspectives from the US FDA, EU, and PIC/S
3. Gain an understanding of key cleaning validation concepts, such as sampling, cleaning, sanitizing, residue limits, microbial control