Short Course Listings
Short Course

Course Information
Course Title: Maintaining Calibration Programs – Compliance Perspective (483s, Warning Letters & Consent Decree)
Categories: 1 - Life Sciences
2 - Management/Professional Development
3 - Quality/Regulatory/Compliance
4 - Electronic Laboratory
5 - Validation
Instructor(s): Andy Ferrell Course Number: 107
Affiliation: PCI-LLC
Course Date: 03/19/2013 - Tuesday Course Length: 1/2 Day Course
Start Time: 01:00 PM End Time: 05:00 PM
Fee: $260 ($360 after 2/18/13) Textbook Fee:

Course Description
Calibration programs are required to comply with Good Manufacturing Practices (GMPs). This course describes the calibration requirements for the life science industry. We will discuss calibration terminologies, out of specifications, and the roles of various site departments related to calibrations. Also covered: US Food and Drug Administration’s (FDA) inspection expectations for instrument calibrations for facilities, equipment, and processes and how this relates to qualification activities. This course further describes actual FDA Warning letters and Consent Decree issues as they relate to Calibration and the areas in which various companies were cited.

Target Audience
Anyone involved in calibration program management. End users, Managers and QA personnel involved with maintenance, calibration and validation activites.

Course Outline
• FDA Warning letters as they relate to Calibration issues
• Consent Decree issues as they relate to Calibration
• Discuss calibration warning letters within the Manufacturing processes
• Discuss calibration warning letters within Lab equipment environment
• Discussion of Requirements for Establishing Instrument Classification, Direct
Impact, In-Direct Impact, No Impact Critical, Tolerances, and Alarm Limits
• Discuss Roles and Responsibilities: Owner/User, Laboratory Personnel, Maintenance Personnel and the Quality Unit

Course Instructor's Biography
Jim 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 attended Regulatory Asset Manager training from Blue Mountain Quality Resources; Blue Mountain is an industry leader in Validated Asset Management software developer.