Perform calibration

Purpose

The most accurate measuring instrument is of little or no use if one cannot guarantee that the measurement is accurate, or if one does not know the measurement uncertainty. The GMP regulations for pharmaceutical manufacturing, 21 CFR Part 211, Article 68(a) and ISO 9001, clearly describe calibration of measuring equipment and emphasize traceability to international or national measurement standards. However, in practice we see that these regulations are interpreted in various ways in order to comply with the laws and regulations without too much effort and without losing product quality.

Target Audience

Employees of pharmaceutical and food organizations who directly or indirectly deal with systems where temperatures and fine adjustments in measured values are important for production with a constant product quality.

Intent

This training consists of 1 half day (4 hours) and deals with the approach, the determination for calibration, the drawing up of a protocol and the implementation.

Program

·        Introduction calibration

·        What does GMP regulation say about this

·        Determining whether an object requires calibration

·        How do you determine the measurement values

·        Write protocol

·        Determining the frequency of execution of measurements

·        Calculate and document results

 Qty participants   8 - 12