Regulatory Requirements and Principles for Cleaning Validation 2017

What topics are covered by the course?

Day 1 Schedule

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 Schedule

Lecture 1:
Laboratory Issues in Cleaning

Lecture 2:
Microbiological aspects of a cleaning validation program for manufacturing equipment

Lecture 3:
Keys to Cleaning Validation Maintenance - Remaining Compliant

Lecture 4:
Current FDA concerns about validation of cleaning processes

Who 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.

What will I be able to do on completion?

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

How will I be assessed?

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.

Senior Quality Managers
Quality Professionals
Production Supervisors
Validation Engineers
Process Owners
Quality Engineers
Quality Auditors

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
support@globalcompliancepanel.com
Toll free: +1-800-447-9407
Phone: +1-510-584-9661
Website: http://www.globalcompliancepanel.com

Registration Link -http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901170SEMINAR?coursesplus-September-2017-SEO

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Guide Price: 1295


Outwood
Lancaster
Wakefield
Delivery: Classroom
Category: Health & Medical »
Duration: 2 days
Qualification: N/A

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