Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
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.
Course Objectives:
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.
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:
• Quality Departments
• Engineering Departments
• Production Departments
• Manufacturing Departments
• Validation Departments
• Operations Departments
• Process Owners
• Quality Auditors
Training for New Technical Writers
LIVE : Scheduled on
13-January-2025 :01:00 PM EST
|