The reasons medical device manufacturers need to perform process validation are two-fold. The first reason is to satisfy FDA requirements. Although this alone would be a sufficient reason, another key reason to perform process validation is to ensure BUSINESS SUCCESS!
Attend this 7 hour webinar and learn the principles and application of successful process validation. Whether you are new to process validation or want to refine and improve your existing program, you will benefit from this informative, practical webinar. You will learn how the current FDA regulations, interpretations and guidelines affect you and how to develop a validation program consistent with compliance and business success.
Cost: $799.00
Length: 7 Hours
Click on the "Add to Cart" button or call 1-719-282-1143 to register for this webinar.
Click on the tabs below for more information.
Objectives
Attendees will:
Become updated on the latest FDA guidelines and interpretations of product/process validation.
Learn basic differences between qualification, verification and validation.
Learn if (and when) validations are required.
Learn to reduce risk while reducing cost.
Develop a Validation Master Plan (VMP).
Determine what activities must be completed prior to conducting a validation event.
Learn how to conduct and document a validation event.
Agenda
Goals, introductions, expectations
Does your organization need to comply?
21 CFR 820 regulation, relevance to process validation
What is process validation? What is verification? What is a process validation protocol?
Brief review of how the industry got to where it is today
How to comply without adding huge costs to product
Decision matrix on when to validate/verify
Primary elements of validation: IQ, OQ, PQ
What are the steps?
What is a validation master plan?
What must the master plan contain?
Examples of actual validation master plans
Details on Installation Qualification (IQ)
What must the IQ contain?
IQ templates
Examples of actual IQ's
Details on Operational Qualification (OQ)
What must the OQ contain?
OQ templates
Examples of actual OQ's
Details on Performance Qualification (PQ)
What must the PQ contain?
PQ templates
Examples of actual PQ's
Writing and getting approval of the validation protocol
What to do about failed tests?
Numerous group exercises
Quiz questions
Trainer
Robert Launsby has taught hundreds of students Process Validation techniques. Bob has consulted with numerous companies in the area of FDA protocols for Process Validation. He is co-author of "Process Validation for Business Success", "Design for Six Sigma", "Engineering Today's Designed Experiments", "Understanding Industrial Designed Experiments" and "Experimental Design for Injection Molding". Bob's presentations are lively and informative. His examples are practical and thought provoking.
Dates
The dates and locations are listed below:
Date
Start Time
October 5, 2011
8:00 am MST
November 7, 2011
8:00 am MST
January 18, 2012
8:00 am MST
Cost
Fees: $799 includes the eBookProcess Validation for Business Success, link to key FDA documents, Participant Guide and copies of example IQ's, OQ's and PQ's.
Guarantee
Launsby Consulting webinars and products are fully guaranteed. If any of our webinars do not meet your needs, contact us and we will promptly send you a refund. If any of our products fail to meet the highest standards of quality and performance, please return them in like-new condition in their original packing materials, and we will send you a refund.
Who Should Attend?
Professionals directly involved in the development and manufacturing of medical devices and meeting the FDA's quality system requirements. Individuals associated with regulatory affairs, quality assurance, process development or manufacturing will find this informative webinar extremely valuable.
Register Early - class sizes are limited for optimal interaction and instruction.
Call 1-719-282-1143 or click on the "Add to Card" button above to Register.
If you have any questions, please feel free to email us at
or
call us at 1-719-282-1143.
The reasons medical device manufacturers need to perform process validation are two-fold. The first reason is to satisfy FDA requirements. Although this alone would be a sufficient reason, another key reason to perform process validation is to ensure BUSINESS SUCCESS!