Course Description

Basic Principles of Cleaning Validation in the Pharmaceutical Industry

This course is not currently scheduled at this time. Click the "Notify Me When Course Is Scheduled" button to be notified when it becomes available.

CfPA can also bring this course to your location. Please click here to learn about our Client Site Program.

Course ID 2809

In-Person Course

Who Should Attend?
Attendance at this seminar 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.

The course will benefit the following individuals:
  • Senior quality managers
  • Quality professionals
  • Production supervisors
  • Validation engineers
  • Process owners
  • Quality engineers
  • Quality auditors

WHAT WILL YOU LEARN BY ATTENDING THIS COURSE?

Meet the Instructor and Learn More


Course Description
This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

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 Director
Joy McElroy, Consultant to the pharmaceutical and biotech industries

With 10 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies. Ms. McElroy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing. In 2013 Ms. McElroy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients worldwide.

Notify Me When Course Is Scheduled