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 Mater 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 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.

Dates/Locations

The 2011 dates and locations are listed below:

Location	Date
Colorado Springs	May 20
San Diego	July 19
Denver	August 15
San Jose	September 16
Phoenix	November 7

Cost

Fees: $995 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.

Guarantee

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.

 

Refund Policy

When cancellations are made at least 14 days prior to the seminar date, we will refund your registration fee minus a $100 processing fee