Practical Approach to Calibration: Applying the GAMP® Good Practice Guide: Calibration Management Principles

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Training

Level: Advanced
ISPE CEUs: 1.3
Type: Classroom Training Course

Description

Calibration is an essential element of compliance in the pharmaceutical industry. To ensure success, calibration must be managed effectively by appropriately qualified and trained personnel with good technical knowledge and practical understanding. If neglected, calibration is capable of compromising both product and plant, and dramatically increasing costs.

The Calibration Management Special Interest Group of the GAMP Forum has produced a guide for the management of calibration in the pharmaceutical industry entitled GAMP Good Practice Guide: Calibration Management. With the guide as a resource, this training course will cover the principles of setting up a calibration management system. Participants will learn a structured approach to instrument criticality assessment. Discussions will center on the management, documentation and corrective actions essential to regulatory compliance, including information on process, system, and laboratory instrumentation. The process of establishing clear procedures and carrying out formal criticality assessments will allow professionals to manage calibration activities so that resources are concentrated where they are most needed. A pragmatic approach to calibration, based on a criticality assessment, will ensure effectiveness and regulatory compliance as cost effectively as possible.

Course Modules

• Day 1
• Day 2
• Exception Report
• Calibration in Practice
• Master List
• Questionnaire

Participants will receive a complimentary copy of the GAMP Good Practice Guide: Calibration Management.

Take Back to Your Job

• Discuss the requirements of the pharmaceutical industry regulators based on the GAMP Good Practice Guide: Calibration Management
• Set up a calibration management system to control activities of in-house or contract staff
• Focus activity on the most important areas and improve cost-effectiveness
• Present documentation in an efficient and effective way and identify errors as the counter-signatory of documentation
• Audit a calibration system and produce an improvement plan by instruction and "hands on" workshop exercises
• Carry out the appropriate follow-up activities to ensure compliance is maintained
• Set up and manage a criticality assessment team to analyze instrumentation and set the appropriate categorization and frequency for required calibration activities
• Carry out a criticality assessment of a system or process and generate a "calibration master list" by instruction and hands-on workshop exercises
• Describe the importance of traceability and the use of reference standards
• Account for errors of uncertainty in the setting of limits

Attendance Suggested For

• Calibration technicians, control engineers, instrument engineers, control technicians
• Professionals involved in quality assurance of control systems, and those checking IQ validation documentation

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.