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Short Course

Course Information
Course Title: Maintaining the Validated State of Analytical Laboratory Instrumentation in GMP/GLP Environments
Categories: 1 - Analytical Metrology
2 - Laboratory Information and Management
3 - Quality/Regulatory/Compliance
4 - Validation
Instructor(s): Freddie Maisonet Course Number: 50
Affiliation: PCI
Course Date: 03/07/2016 - Monday Course Length: 1/2 Day Course
Start Time: 01:00 PM End Time: 05:00 PM
Fee: $300 ($400 after 2/12/16) Textbook Fee:

Course Description
All organizations should establish requirements, within their given Quality System, that govern the maintenance and calibration of analytical laboratory instrumentation. Calibration programs are required to comply with Federal laws and mandates. This course overviews the necessary step for analytical laboratories to maintain a validated state of instrumentation and the calibration requirements for the life science industry. We will discuss calibration terminologies, specific regulations and the roles of the scientists and personal related to calibrations.

Target Audience
Quality Managers Laboratory Managers Maintenance Personnel Laboratory Technicians

Course Outline
• Industry Regulations (CFR) vs. Guidelines (AIQ)
• Review of the Element for a Good Quality System
• Calibration requirements for Instrumentation within the Life Sciences
• Preventive, Corrective, and Post Calibration Maintenance
• Documentation Requirements
• Overview of the Roles and Responsibilities: Owner/User, Laboratory Personnel, Maintenance Personnel and the Quality Unit

Course Instructor's Biography
Freddie A. Maisonet has been working in the pharmaceutical industry since 1998. His areas of expertise are in Analytical Instrumentation, calibration program management, maintenance, and equipment qualification. His accomplishments include method development for analytical systems for the environmental and life sciences industries, calibration and qualification of instrumentation, procedure writing, instrument assessment, calibration management and technical training.