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Instrument control and record - keeping

This course provides participants with a comprehensive understanding of instrument control and record-keeping practices required to ensure the accuracy, reliability, and traceability of laboratory and manufacturing equipment. It covers the lifecycle management of instruments, including qualification, calibration, maintenance, documentation, and record retention in accordance with GMP, GLP, and regulatory requirements. Participants will learn best practices for maintaining instrument integrity and ensuring compliance through effective documentation and data management.

4 hr

Created by Dr. YASSER MEKKY

EN/AR [Auto]

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# Content
1 Module 1: Introduction to Instrument Control
2 Module 2: Instrument Qualification and Calibration
3 Module 3: Preventive Maintenance and Instrument Control
4 Module 4: Record Keeping and Documentation
5 Module 5: Data Integrity and Electronic Records
6 Module 6: Change Control and Deviations
7 Module 7: Inspection Readiness and Compliance
8 Module 8: Case Studies and Practical Exercises
# Outcomes
• Explain the importance of instrument control within pharmaceutical quality systems.
• Manage instrument qualification, calibration, maintenance, and performance verification activities.
• Maintain equipment logbooks and related documentation in compliance with GMP requirements.
• Apply data integrity principles to instrument-generated records.
• Identify documentation deficiencies and implement corrective actions.
• Ensure traceability and retention of instrument records.
• Demonstrate compliance with regulatory expectations during audits and inspections.
# Participants
1
• Quality Assurance (QA) professionals.
2
• Quality Control (QC) analysts and supervisors.
3
• Analytical and Microbiology laboratory personnel.
4
• Production and Manufacturing staff.
5
• Engineering and Maintenance personnel.
6
• Validation and Qualification specialists.
7
• Regulatory Affairs and Compliance professionals.
8
• Laboratory managers and supervisors.
9
• Pharmaceutical and biotechnology industry professionals responsible for equipment management and documentation.