Paul Pluta, Ph.D.
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Visiting Clinical Associate Professor Contact Information 833 South Wood Street Pharm 237 Chicago, IL 60612-7231 Office: (312) 996-8408 Email: ppluta@uic.edu |
Publications (2007 - 2012):
Pluta, P. (2009). Cleaning and Cleaning Validation (Vol. 1). Bethesda: Parental Drug Association.
Pluta, P. L.. (2011). QdB and Process Validation - Complementary Lifecycle Approaches. In: Schmitt, S. Quality by Design: Putting Theory into Practice. Bethesda: Parental Drug Association. p115-162.
Pluta, P. L., Poska, R., and Fields, T.J. (2011) Compliance by Design (CbD) and Compliance Master Plan (CMP) – Lifecycle Approach to Quality Systems and Complance. In: Schmitt, S. Quality by Design: Putting Theory into Practice. Bethesda: Parental Drug Association. P287-314.
Pluta, P.L., Poska, R., and Fields, T.J. (2011, March) Compliance by Design and Compliance Master Plan. Pharmaceutical Technology, 35(3), 90-96.
Graham, B., Poska, R., Ertmann, R., and Pluta, P.L. (2011, August). Audit 101: Preparation, Preparation, and More Preparation. The Journal of Validation Technology, 17(4), 68-75.
Pluta, P. L. (2011). Audit 101: First Impressions – The Plant Tour. Journal of GXP Compliance, 15(1), 16-22.
Pluta, P.L. and Poska, R. (2010). Compliance by Design (CbD) and Compliance Master Plan (CMP) – An Organized Approach to Compliance. Journal of GXP Compliance, 14(2), 73-82.
Pluta, P.L. (2010). Validation Case Studies: Case Study #3 – Process Validation Failure of a Liquid Product Batch Size Increase – “Identical” Manufacturing Tanks. The Journal of Validation Technology, 16(3), 18-23.
Pluta, P.L. (2010). PQ Forum: Validation Report Conclusion – Is It Validated?. The Journal of Validation Technology, 16(3), 39-42.
Pluta, P.L. and Fields, T. (2011). Validation Case Studies: Sustandard Data and Documentation Practices – Case Study #5. The Journal of Validation Technology, 17(1), 55-61.
Pluta, P.L. (2011). PQ Forum: Responsibilities of the Validation Approval Committee. The Journal of Validation Technology, 17(1), 50-54.
Awards
2011 – IVT Speaker of the Year
Editor
Editor-in-Chief: The Journal of Validation Technology
Editor-in-Chief: Journal of GXP Compliance