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.
Why You Should Attend:
Attendance at 2 day 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.
- 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
Who Should Attend:
Management and Staff from:
- Quality Assurance Departments
- Quality Control Departments
- Production Departments
- Validation Departments
- Engineering Departments
- Operations Departments
- Analytical Method Development Teams
- Process Owners
- Laboratory Personnel
- Quality Auditors
DAY 1 (9 AM – 5 PM):
Registration Process – (9:00 AM – 9:30 AM)
Lecture 1 – FDA Requirements and Industry Standard Practices
Lecture 2 – How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters
Lecture 3 – How to Develop a Cleaning Validation Policy/Program
Lecture 4 – How to Implement a Robust Cleaning Validation Plan
DAY 2 (9 AM – 5 PM):
Lecture 5 – Laboratory Issues in Cleaning
Lecture 6 – Microbiological aspects of a cleaning validation program for manufacturing equipment
Lecture 7 – Keys to Cleaning Validation Maintenance – Remaining Compliant
Lecture 8 – Current FDA concerns about validation of cleaning processes
Co-Owner of Maynard Consulting Company
Joy McElroy offers 14 years of experience as a consultant and over 20 years’ total experience in the pharmaceutical and biotech industries in quality control, clinical settings, good manufacturing practice (GMP) auditing as well as validation engineering. McElroy specializes in equipment qualification, cleaning validation, sterilization, environmental monitoring, GMP compliance auditing, good documentation practices, GMP and good laboratory practice training. She has written and executed equipment qualification and validation protocols for numerous companies. Joy is co-owner of Maynard Consulting Company.
- Make Secure Payment using Credit Card
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- Please choose your option (No. of delegates) from the drop down and click on Add to basket
- Click on Proceed to Checkout on the Cart Page, and complete the registration.
- Once the payment is completed, you will be receiving a Form to fill up the Delegates Information
- An electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date.
- Please bring the respective passes to the event venue.
Pay by Wire:
- Please contact our support to assist you with registration by Wire
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- Mail the check to:
FutureCorp Consulting Inc
5939, Candlebrook Ct.,
Mississauga, ON L5V 2V5,
- Once we receive the check, you will be receiving a Form to fill up the Delegates Information
- After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.
Hyatt Regency Houston Intercontinental Airport
Houston, TX, USA | March 7 – 8, 2019