GMP Compliant Instrument Calibration and Qualification
On-demand Webinar Helps Laboratories to Maintain Compliance and Deliver High Quality Results
Calibration and qualification of laboratory instruments, supported by ongoing routine testing, are critical to ensure accurate results and regulatory compliance. Understanding the relationship between these factors is key to achieve high quality results and ensure audit readiness.
Calibration is relevant to every laboratory, whatever their scientific discipline. No matter how precise an instrument measurement is, it is of little or no use unless the reading is guaranteed to be accurate, or if the user is unaware of the measurement uncertainty. The US FDA 21 CFR Part 211, Current good manufacturing practice for finished pharmaceuticals, article 68(a), provides details on the calibration of measuring equipment. Similar statements can be found in other regulatory or guidance documents, such as ISO 9001, which emphasizes the traceability to international or national measurement standards. The challenge for laboratories is how best to put these regulations into practice, ensuring that they comply with the regulatory requirements without increasing the workload excessively, or compromising the product quality.
This 60-minute webinar explains all aspects of calibration, qualification and routine testing of laboratory instruments, to help safeguard the quality of results and maintain compliance with USP and GLP/GMP regulations. It focuses on laboratory weighing instruments, discussing equipment qualification (EQ) responsibilities – design, installation, operational and performance qualification (DQ/IQ/OQ/PQ) – and how they relate to standard operating procedures.
Key learning objectives:
- How to achieve effective calibration, including determination of measurement uncertainty, in accordance with GMP and USP requirements
- Understanding the roles and responsibilities of different parties with regards to qualification processes (EQ/IQ/OQ/PQ)
- Recognizing the impact of risk-based routine testing on the quality, efficiency and cost optimization of laboratory weighing processes.
The webinar will be of interest to:
- Anyone involved with qualification, testing and calibration of instruments in a GMP-regulated laboratory
- Quality assurance personnel
- Compliance managers and regulatory affairs managers
- GMP and CMC consultants, GLP auditors and quality consultants
- Laboratory managers, laboratory supervisors and production managers
- Auditors (internal and external) responsible for assessing laboratory instrument compliance
Duration: 60 minutes
Language: English, Russian