Short Course Listings
Short Course

Course Information
Course Title: (CANCELED) Maintaining Calibration Programs – Compliance Perspective (483s, Warning Letters and Consent Decree)
Categories: 1 - Analytical Metrology
2 - Data Management
3 - Quality/Regulatory/Compliance
4 - Electronic Laboratory
5 - Laboratory Information and Management
Instructor(s): Nick Jones Course Number: 125
Affiliation: PCI
Course Date: 03/09/2017 - Thursday Course Length: 1/2 Day Course
Start Time: 08:30 AM End Time: 12:30 PM
Fee: $325 ($425 after 2/18/17) 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
Calibration Technicians Laboratory Technicians Laboratory Managers Quality Assurance Maintenance personnel

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
Mr. Jones has areas of expertise in the oversight and services of analytical laboratory equipment maintenance, calibration, qualification and troubleshooting. He has been involved in not only the routine support services of instrumentation but also in method development, technical writing and protocol development for various types of analytical equipment. He also has significant experience in the critical assessment of analytical and process equipment. Currently Mr. Jones supports the full life cycle of analytical equipment. He routinely provides consulting services relative to asset management programs, maintenance management, calibration management, validation assessment and compliance gap assessment.