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Short Course

Course Information
Course Title: Developing and Implementing Calibration Programs
Categories: 1 - Analytical Metrology
2 - Laboratory Information and Management
3 - Data Management
4 - Quality/Regulatory/Compliance
5 - Electronic Laboratory
Instructor(s): Jon Doyle Course Number: 47
Affiliation: PCI
Course Date: 03/07/2016 - Monday Course Length: 1/2 Day Course
Start Time: 08:30 AM End Time: 12:30 PM
Fee: $300 ($400 after 2/12/16) Textbook Fee:

Course Description
Developing Calibration programs for initial startup facilities to redesigning an existing Calibration program will be discussed in detail. Real examples of startup facilities implementing successful calibration programs that do it right the first time. Learn how to redesign your calibration program to implement a paperless system that reduces compliance risk. Learn how to evaluate your instrumentation classifications and reduce non-valued deviations that don’t add to the bottom line.

Target Audience
Laboratory Managers Instrumentation Supervisors Calibration Program Managers Quality Assurance Maintenance Managers

Course Outline
• Calibration Program Overview
 Procedures
 Classifications
 Documentation (paperless?)
 Work flow resources
• Designing a calibration program for a new facility
 When do you get calibration involved?
 Eliminate the useless construction calibration
 Calibration software / paperless?
 Commissioning Phase
 Production Phase
• Redesign Your Calibration Program
 Commitment to Excellence
 Resource Allocation
 Procedure Revisions
 Software Changes?
 Training

Course Instructor's Biography
Jon Doyle is a Sr. Consultant with Pharmaceutical Calibrations and Instrumentation (PCI). Jon has worked for PCI several years and is located in Raleigh, NC. He has been in the life-sciences industry for over 15 years primarily building, managing, remediating, and streamlining several life sciences calibration programs. He has experience in Quality Control and Maintenance systems as well as various computerized asset management systems. PCI is a full scope calibration service provider which has several locations throughout the United States.