Articles by Lynn D. Torbeck - Pharmaceutical Technology

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Articles by Lynn D. Torbeck

Lynn D. Torbeck

international consultant and trainer

http://www.torbeck.org

Lynn D. Torbeck is an international consultant and trainer specializing in applied statistics and experimental design for pharmaceutical, biopharmaceutical, and medical device research and development, validation, quality control/assurance, and production, 2000 Dempster Plaza, Evanston, IL 60202, tel. 847.424.1314.

Articles
Compositing Samples and the Risk to Product Quality
May 2, 2013

Compositing samples is appropriate under certain circumstances but raises caveats on how and when it should be applied.

Time to Revise ICH Q9
December 2, 2012

A change in terminology could emphasize patient protection.

Tools in Waiting: Time for Evolutionary Operation
October 2, 2012

Real-time experimentation may offer continuous process improvement.

A Statistical Review of ICH Q10 Pharmaceutical Quality System
August 2, 2012

Applying the recommendations of ICH Q10 to statistical analysis can help prevent product recalls.

Placket–Burman Designs
July 2, 2012

Applying current principals to traditional factorial designs.

Representative Sampling
April 2, 2012

Understanding the differences between convenience, target, and self-selected samples.

Reducing Common Cause Variation
February 2, 2012

Where is the variability coming from and what have we done to minimize it?

Out-of-Specification Sample-Size Confusion
December 2, 2011

Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria.

OOS, OOT, OOC, and OOSC
October 2, 2011

Current GMPs demand full understandng of out-of-control concepts. This article contains bonus material.

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