This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
This course will provide practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a “Cleaning Validation Master Plan” and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.
Areas Covered in the Session :
FDA Requirements and Industry Standard Practices
How to Develop/Review Your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters
How to Develop a Cleaning Validation Policy/Program
How to Implement a Robust Cleaning Validation Plan
Laboratory Issues in Cleaning
Microbiological Aspects of a Cleaning Validation Program for Manufacturing Equipment
Keys to Cleaning Validation Maintenance – Remaining Compliant
Current FDA Concerns About Validation of Cleaning Processes
Who Should Attend:
Quality Departments
Engineering Departments
Production Departments
Manufacturing Departments
Validation Departments
Operations Departments
Process Owners
Quality Auditors