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Short Course

Course Information
Course Title: Developing and Implementing Calibration Programs
Categories: 1 - Analytical Metrology
2 - Data Management
3 - Quality/Regulatory/Compliance
4 - Electronic Laboratory
5 - Laboratory Information and Management
Instructor(s): Donald Stuck Course Number: 120
Affiliation: PCI
Course Date: 03/06/2017 - Monday Course Length: 1/2 Day Course
Start Time: 01:00 PM End Time: 05:00 PM
Fee: $325 ($425 after 2/18/17) 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
As the founder of PCI, LLC in 1996, Mr. Ferrell oversees a management team who are responsible for the general operations of the company. PCI specializes in cGMP programs development and providing clients with technical resources to meet their needs. Mr. Ferrell has experience in biopharmaceutical facility start up projects. Prior to PCI, Mr. Ferrell held progressive project management and operations positions with Burroughs Wellcome, GlaxoWellcome and Pharmaceutical Solutions. Mr. Ferrell has a long history of working with analyzing business process and compliance requirements in order to establish organizational structures that match the current risk tolerance for many life science companies. He has been in the pharmaceutical, biotechnology and medical device industries since 1989, providing technical and consulting services, some of which include quality system audits, compliance training, business process analysis, workflow development, and calibration and validation services. In 2000, he founded the Calibration Discussion Group which is an annual event in which thought leaders from around the country convene to discuss innovated approaches to reduce cost, improve compliance, and increase operational efficiencies relative to maintenance and calibrations. Mr. Ferrell holds a Master’s Degree in Industrial Technology from East Carolina University. He is an active member of ISPE, PDA, ISA, and ASQ. He currently serves as a Board Director on the following: ISPE CaSA Chapter, ECU Medical & Health Sciences Foundation, ECU Engineering Department, as well as the Advisory Council of ECU’s College of Technology & Computer Science.