Real Time PCR Solutions for Food Safety

Sampling Strategies - Is the √N rule always the Best?

2018, June 12 - 13

Pharmaceutical » Training

The Course will cover the Comprehensive and Effective Sampling of Finished Pharmaceutical Products, APIs, Excipients, Package Components and Medical Devices

The following issues will be addressed:
Regulatory and compendial requirements around sampling
Acquaintance with basic sampling distributions
Classification of non-conformities and allocating AQL to classes
Acceptance Sampling Plans in ISO-2859-1/ANSI Z1.4
Understanding the risks of producer and consumer associated with the sampling plans
Sampling for visual inspection of particles in drugs
How to effectively reduce the amount of samples to be tested?
Sampling of powders (APIs and excipients) / Sampling according to the WHO Guide
Tools for sampling in a pharmaceutical plant
Sampling and inspection of packaging materials
Charting and trending non-conformities and non-conforming items
Good quality practice around sampling plans
√N rule: its uses and misuses

For more information visit




Concept Heidelberg
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