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Institute of Validation Technology

Laboratory Compliance Training Seminar
47 East Robinson Street, Suite 202
Orlando, FL 32801
Phone: 407-236-9401 Fax: 407-236-9402
Web Site: www.ivthome.com

Course Leader
Jeff Morgan, Principal Consultant
JWM Associates, Biomedical Consulting

Program Schedule
8:00 AM ........................................Registration and
Continental Breakfast
8:30 AM ........................................Course Begins
5:00 PM ........................................Course Ends
I. Specifications for Quality Laboratory Practice
o Learn how to perform a specifications survey
o Learn the five critical steps to a quality laboratory
o Learn how to "personalize" the laboratory by application of
specifications
o The laboratory environment - it does matter
II. Specifications for Equipment - Quality and Tolerances
o Learn how to investigate before you invest
o Learn how manufacturer specifications apply in your labo-ratory
environment
o Learn why your specifications may differ from the manufac-turer
and why this is acceptable
o Plan for obsolescence
III. Setting Specifications for Supplies and Materials
o Assign quality principles for your supply needs
o Develop the cost/quality principles
o Know what you need and how to get it
o The certificate of analysis - don't count on it
IV. Specifications for Analytical Methods
o Save time by applying specifications for analysis
o Learn how to develop assay acceptance criteria
o Evolution, assessment, and reestablishment
o Understand and apply change controls
V. Sample Quality for Analytical Laboratories
o Understand why you are in control
o Apply sample requirements specifications to ensure quality
results
o The sample chain of quality - action specifications
VI. The Dynamic Use of Quality Control (QC)
Specifications for Analytical Methods
o Learn how to apply basic quality control principles to all lab-oratory
analyses
o Research, QC, and specifications - they can coexist
o Develop "user-friendly" systems
o Learn why you need historical review of QC data
VII. Application of Specifications to Regulatory
Requirements
o Learn how to develop a practical corrective action system
o Learn how to apply corrective action to strategic planning
o Understand "negative data" - it's not always bad
o Overview of the use of specifications for development of
preventive action measures
VIII. Development of Specifications for Quality Data
Reporting
o Global applications: from the bench to the recipient
o Specify elements of data presentation
o Laboratory notebooks - the "black hole" for data
o Painless review

SETTING SPECIFICATIONS FOR THE LABORATORY

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