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Best Practices for Effective Cleaning Validation

Duration : 90 Minutes

Joy L. McElroy,

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing.  Her work allowed her to move into a supervisory role at Abbott Labo Read more

This course provides 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.

Course 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

Why Should You Attend:

Attendance at 90-minute webinar 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 includes Analytical Method Development, Quality Control, and Quality Assurance personnel.

Individuals in management who interact with the above 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.

Course Outline:

•  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

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

•  Senior quality managers
•  Quality professionals
•  Production supervisors
•  Validation engineers
•  Process owners
•  Quality engineers
•  Quality auditors

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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