Statistics for GMP Auditors April 18, 2013

This training on statistics used in the life sciences industry will introduce participants to statistics frequently encountered and assessed or even critiqued in the course of GMP auditing.

Why Should You Attend:

You should attend this webinar if

i.You are already a full-time GMP auditor, or
ii.you may be called upon periodically to assist on an audit team,
iii.you may be called upon to perform a localized form of GMP audit known as department self-inspection, or
iv.you are a stakeholder (recipient and possibly someone required to follow-up with corrective actions) of GMP audits.

This session will provide an introduction to statistics frequently encountered and assessed or even critiqued (i.e., written up) in the course of GMP auditing. This webinar will provide initial familiarity and appreciation for statistics used to describe results or measures of life science industry materials and processes.

Areas Covered in the Webinar:

- Acceptance Sampling Plans for Attributes.
- Sampling by an Auditor-A Proposed Method.
- Sampling API Shipments/Containers and Composite Sampling.
- Graphing Time-Based Process Data & Recognizing Trends (or “out of trends”)
- Process Capability Indices and Inferring PPM Nonconforming.
- Blend Uniformity Statistics.
- Uniformity of Dosage Units Statistics.
- Outlier Statistics Used in Some QA Investigations.
- Statistical Acceptance Criteria for Analytical Method Technology Transfer.
- Reserve and Retain Samples in the US and EU GMP Regulations.
- Examples of Audit Observations for Improper Sampling Plans or Statistics Usage.