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.
Why Should You Attend:
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.Learning Objectives:
- Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
- Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
- Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
- Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies
Areas Covered in the Webinar:
- 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 Will Benefit:
Individuals in management who interact with or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.- Senior quality managers
- Quality professionals
- Production supervisors
- Validation engineers
- Process owners
- Quality engineers
- Quality auditors
- Analytical method development personnel
- Quality control and quality assurance personnel
Course Provider
Joy McElroy,
