Course Information
Course Title: Developing and Implementing Calibration Programs - Going Paperless
Categories: 1 - Life Sciences
2 - Management/Professional Development
3 - Quality/Regulatory/Compliance
4 - Validation
Instructor(s): Andy Ferrell Course Number: 120
Affiliation: PCI
Course Date: 03/13/2012 - Tuesday Course Length: 1/2 Day Course
Start Time: 01:00 PM End Time: 05:00 PM
Fee: $235 ($335 after 2/13/12) 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
All Professionals responsible for calibration management programs. Anyone involved with general equipment compliance. Anyone interested in going paperless (paperless calibration programs).

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
Mr. Bufano has been working in the pharmaceutical industry since 1985. His areas of expertise are in calibration, calibration program development, regulatory auditing, maintenance, engineering, validation, commissioning & qualification. His accomplishments include development of calibration programs to assist clients in starting a calibration program to include procedures, calibration software implementation and validation, procedure writing, instrument assessment, calibration management and technician training. He has facilitated the Calibration Discussion Group events, ISPE course leader, and section coordinator for the NCSL. Jim has recently attended Regulatory Asset Manager training from Blue Mountain Quality Resources; Blue Mountain is an industry leader in Validated Asset Management software developer.