It is a legal requirement that medical device manufacturers need to perform process validation. If not approached in a wise manner, however, it can be extremely costly. Increasingly, organizations are overwhelmed by the cost of this activity yet worried that defective product may be shipped to customers.
Attend this one day seminar and learn the principles of successful, cost effective 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 seminar. 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.
Call 1-719-282-1143 to Register.
Click on the tabs below for more information.
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 Mater Plan (VMP).
Determine what activities must be completed prior to conducting a validation event.
Learn how to conduct and document a validation event.
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?
Examples of actual IQ's
Details on Operational Qualification (OQ)
What must the OQ contain?
Examples of actual OQ's
Details on Performance Qualification (PQ)
What must the PQ contain?
Examples of actual PQ's
Writing and getting approval of the validation protocol
What to do about failed tests?
Numerous group exercises
Robert Launsby has taught thousands of students Design of Experiments techniques and hundreds in the area of Six Sigma. 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.
The 2013 dates and locations are listed below:
Fees: $1295 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. Lunch and coffee breaks are provided each day.
Launsby Consulting seminars and products are fully guaranteed. If any of our seminars 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.
When cancellations are made at least 14 days prior to the seminar date, we will refund your registration fee minus a $100 processing fee.
When cancellations are made at least 14 days prior to the seminar date, we will refund your registration fee minus a $100 processing fee
Register Early - class sizes are limited for optimal interaction and instruction.
Call 1-719-282-1143 to Register.
If you have any questions, please feel free to email us at
call us at 1-719-282-1143.