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FDA GMP Quality System Regulation

FDA QSR Statistical Techniques

The use of statistical techniques can be highly effective in process control, for confirming process capability, to ensure product suitability for use, in the analysis of yields, to analyse customer feedback data, etc.. Therefore, where suitable, statistical analysis should be considered and applied. If however applied, the statistical analytical methods need to be appropriate and valid.

FDA QSR Statistical Techniques

Validation. Classification. Regulation. Requirements. Best practices.
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If statistical sampling plans or other statistical analytical techniques are utilized, the techniques needs to be defined and documented. Individuals using, need to understand how to apply.


FDA QSR Statistical Techniques Regulations.

Subpart O–Statistical Techniques.
Sec. 820.250 Statistical techniques.

(a) Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics.

(b) Sampling plans, when used, shall be written and based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented.

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Medical Device:

      • Validation. Classification. Regulation. Requirements. Current best practices.
      • FDA cGMP’s. EU MDR’s / MDD’s.
      • FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
      • FDA Medical Device Classification. The FDA approach to Medical Device Classification.
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      • New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
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      • Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
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