Publications
Writings of Lynn D Torbeck & Jason J. Orloff represent over 30 years of work in pharmaceutical development and manufacture.
Books
- Torbeck, L. D.,Ed, “Pharmaceutical and Medical Device Validation by Experimental Design,” NY, NY, informa healthcare, 2007.
- Torbeck, L. D., “Validation by Design®,” River Grove, IL, Davis Healthcare International Publishing. 2010.
- Torbeck, L. D., “Using Statistics to Measure and Improve Quality,” River Grove, IL, DHI Publishing (2004).
Book Chapter
Journal Articles by Lynn Torbeck
- “Ruggedness and Robustness with Designed Experiments,” Pharmaceutical Technology (March 1996).
- “Designed Experiments – A Vital Role in Validation,” with R. C. Branning, Pharmaceutical Technology (June 1996).
- “Valid Sampling Plans: A Case Study,” The Validation Consultant (Vol. 4 No. 3, March 1997).
- “Coefficient of Accuracy and Concordance Correlation Coefficient: New Statistics for Method Comparison,” with Lawrence Lin, PDA Journal of Pharmaceutical Science & Technology ( Vol. 52, No. 2 / March-April 1998).
- “Outlier Management,” FDA Regulator & Quality Advisor (Vol. 6, No. 2) February 1999.
- “Reportable Values for Out-of-Specification Test Results,” Pharmaceutical Technology, Analytical Validation Supplement, (Vol. 23, No. 2, February 1999).
- “Statistical Thinking,” Pharmaceutical Technology (July 2001).
- “Preventing the Practice of Testing Into Compliance,” Pharmaceutical Technology (October 2002).
- “Significant Digits and Rounding,” Pharmacopeial Forum, Vol. 30(3) [May-June 2004].
- “In Defense of USP Singlet Testing,” Pharmaceutical Technology,(February, 2005).
- “The Sector Chart: A New Engineering Graph for Pharmaceutical Processes,” Pharmaceutical Technology, (April, 2005).
- “PAT: Deja’ vu All Over Again?” PDA Letter, October 2006.
- “OOS Final Guidance: What Has Changed?,” PDA Letter, January 2007.
- “Statistical Implication of the CGMPs: A 30-Year Retrospective,” Pharmaceutical Technology, July 2, 2007.
- “Method Comparability,” FDA News & Information, Vol. 8, Num. 31, October 12, 2007.
- Discussion of Journal article: “Statistics in Pharmaceutical Development and Manufacturing.” Journal of Quality Technology, Vol. 41, No. 2, April 2009.
- “Square Root of (N)+1 Sampling Plan,” Pharmaceutical Technology, October 2009.
- “Can We Save the Technical Conference?” Pharmaceutical Technology, December 2009.
- “%RSD: Friend or Foe?” Pharmaceutical Technology, January 2010.
- “The Role of Statistical Significance Tests,” Pharmaceutical Technology, March 2010.
- “Bergum’s Method Recognized,” Pharmaceutical Technology, May 2010.
- “On the Verge of Significance: Why 5%?” Pharmaceutical Technology, July 2010.
- “Numerical Evaluation of Training,” Journal of GXP, Vol. 14, No. 3, Summer, 2010.
- “Visual Inspection Goes Viral,” Pharmaceutical Technology, September 2010.
- “Walk Like a Statistician, “ Pharmaceutical Technology, November 2, 2010.
- “Can AQL be Zero?” PDA Letter, January 2011.
- “Implementing the Tools of Process Quality–A Policy Statement,” Journal of GXP, Winter 2011.
- “Data Culture” JGxP, Spring, Vol. 15, No. 2, 2011
- “Pitfalls in Statistics”, Pharmaceutical Technology”, April 2, 2011, Vol. 35, No. 4
- “Statistics in the service of Quality”, Pharmaceutical Technology, Vol. 35, No.6, June 2, 2011
- “An Example of Absence of a Data Culture”, JGXP, Summer, 2011, Vol. 15, No. 3
- “Quality by Design Circa 1982”, JGXP, Vol. 15, No. 4, Autumn 2011
- “Secrets to Variability Reduction”, JVT, Autumn, 2011
- “Data Culture”, JVT, Autumn 2011
- “Implementing the Tools of Process Quality” A Policy Statement”, JGXP, Winter 2011, Vol. 15, No. 1
- “OOS, OOT, OOC, and OOSC”, Pharmaceutical Technology, Vol. 35, No. 10, October 2, 2011
- “Out-of-Specification Sample Size Problem”, Pharmaceutical Technology, Vol. 35, No. 12, December 2, 2011
- “Design Space Circa 1987”, JGXP, Winter 2012, Vol. 16, No. 1
- “Reduce Common Cause Variability”, Pharmaceutical Technology, Vol. 36, No. 2, February 2, 2011.
Journal Articles by Jason Orloff
Other Journal Articles
- Soms, A., “Randomization Tests for K Sample Binomial Data,” Journal of Quality Technology, Vol. 14, No. 4, October 1982.
- Branning, R., Torbeck, L., and Campbell, C., “Quality by Design, Validation, and PAT: Operational, Statistical, an Engineering Perspectives,” Pharmaceutical Engineering, November/December 2006.
- Branning, R. and Torbeck, L., “QbD: Convincing the Skeptics,” BioPharm International, May 2009.
- Torbeck, L., Friedman, R. and Smedley, M. “An Overview of the CDER Drug Recall Root Cause Research Project,” Pharmaceutical Technology, August 2, 2009.
- Torbeck, L., Friedman, R. and Smedley, M. “An Overview of the CDER Drug Recall Root Cause Research Project,” Pharmaceutical Technology, August 2, 2009.
- Friedman, R., Smedley, M., Torbeck, L. and Santiago, I.“An Initial Report of CDER’s Recall Root Cause Research Project (Part II),” Pharmaceutical Technology, February, 2011.
Online Articles
Audio Presentation
Webcasts
- “Design Space: DOE for PAT and ICH Q8,” October 4, 2006 and March 8, 2007, PDA Web Seminar.
- “Preventing OOS Deficiencies,” PDA Web Seminar, May 24, 2006.
- “FDA Final Guidance: Investigating Out of Specification Test Results,” PDA Web Seminar, March 8, 2007.
- “Process Consistency and Variability Reduction,” PowerPoint presentation by phone to PDA conference, Verona, Italy, March 26, 2007.
- “Ten Deadly Statistical Traps in Pharmaceutical Quality Control,” Pharm Tech Web Seminar, March 29, 2007.
- “How to Fake Being a Statistician: Mastering Napkin Statistics,” IVT Web Seminar, September 20, 2007.
- “Statistical Basis for Quality by Design,” IVT Web Seminar, April 10, 2008.
- “Case Studies in Quality by Design with Design of Experiments from Pharmaceutical Technology,” Pharm Tech Web Seminar, August 19, 2008.
Public Presentations
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