BergumSTATS, LLC
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Statistical Consulting
Presentations
“ISPE PV Good Practice Guide including New Statistically Based Criteria for Content Uniformity”, Process Validation Statistics Conference (Sep, 2017)
“Process Validation: Statistical Methods for Evaluating Uniformity of Dosage Units” Joint Statistical Meeting (Jul, 2017)
“Statistically Based Process Validation (PPQ)/Continuous Process Verification (CPV) Acceptance Criteria”, FDA (Aug 2017)
“Statistically Based Process Validation (PPQ)/Continuous Process Verification (CPV) Acceptance Criteria”, PV Summit, PharmEd Resources, (May, 2017)
"Update on ISPE Blend Uniformity and Content Uniformity (BUCU) Initiative, ISPE Process Validation Conference (October, 2016)
"Sampling Plans and Acceptance Criteria", IVT Statistics in Validation Conference (June, 2016)
“Recommendations for the Assessment of Blend and Content Uniformity: Modifications to Withdrawn FDA Draft Stratified Sampling Guidance and a comparison of two methods (Tolerance Interval/ASTM E2709/E2810)”, ISPE/PQRI Process Validation Conference, (October 2015)
“Tolerance Interval Alternative to ASTM E2709/E2810 Methodology to Provide Assurance of Passing the USP Uniformity of Dosage Unit (UDU) Test <905>”, ISPE Statistician Forum, (April, 2015) & IFPAC Annual Meeting(January 2015)
“Assessment of Blend and Content Uniformity. Technical Discussion of Sampling Plans and Application of ASTM E2709/E2810”, ISPE Statistician Forum, (April, 2015)
“Statistically Based Process Validation Sampling Plans/Acceptance Criteria”, PV Summit, PharmEd Resources, (March & October, 2015)
“Assessing Blend and Content Uniformity: Application of ASTM E2709/E2810 for Assessing Uniformity”, ISPE/FDA CGMP Conference, (May, 2014)
“Assessing Blend and Content Uniformity: Sampling Plans”, ISPE/FDA CGMP Conference, (May, 2014)
“Blend Uniformity”, “Monte Carlo (Outputs)”, “Transition to Stage 3b: Tiered Approach – ASTM to Justify Routine Testing & Sampling”, ”ASTM E2709/E2810 Method to Assess PPQ Performance”, ISPE Process Validation Statisticians Forum (2014)
“Using ASTM E2709/E2810 for Within Batch Variability Assessment During Process Validation and/or Batch Release”, ISPE Process Validation Conference (2013)
ISPE Annual Meeting, “Sampling Plans and Statistical Methods for Process Validation”, (2013)
ISPE Conference, Lessons From 483's: Enhancing Efficiency, Quality and cGMP Compliance Process Validation Track, "A Statistically Based PPQ Acceptance Criterion (ASTM 2709 and E2810) and Sample Size Determination" (2012)
FDA/Industry Workshop, “Statistical Considerations when Evaluating Content Uniformity” (2011)
PQRI Sample Size Workshop, “Demonstrating Capability to Comply With a Test Procedure - The Content Uniformity and Dissolution Acceptance Limits (CuDAL) Approach” (2011)
NJPhast, “Statistical Considerations when Evaluating Content Uniformity” (2011)
New Jersey Chromatography Group, "Blending Statistics With Analytical Chemistry" (2007)
Institute of Validation Technology, "Statistical Design & Analysis of Stability Studies", (2004, 2005)
AAPS Short Courses: "Analytical Method Validation" & "Design of Experiments" (1994,1998)
Pharmaceutical Education & Research Institute (PERI), "Training Course for Non-Clinical Statistics" (Presenter & Course Director 1994 - 2001)
IBC Conference, "Achieving Excellence in Analytical Validation" (2000)
Midwest Biopharmaceutical Statistics Workshop (Co-chair 1997)
Invited Speaker at several American Statistical Association Meetings.
Parenteral Drug Association (PDA) Conference, "Learning form the Barr Decision" (1993)
“Extensions to the ICH Q1E Approach for the Statistical Evaluation of Stability Data for a Large Number of Lots”, Journal of Pharmaceutical Innovation, Co-Authored with Yijie Dong, Siheng He, (December 2017)
“Tolerance Interval Alternative to ASTM E2709/E2810 Methodology to Provide Assurance of Passing the USP Uniformity of Dosage Unit (UDU) Test <905>”, Pharmaceutical Engineering (December 2015), 68-79
"Content Uniformity Discussions: Current USP <905> Developments Regarding <905> and a Comparison of Two Relevant Statistical Approaches to Assess Content Uniformity", Pharmaceutical Engineering, Coauthored with William Brown, Jon Clark, Thomas Parks, Thomas Garcia, James Prescott, Charles Hoiberg, Samir Patel, Ravindra Tejwani (August 2015) 52-56
“Recommendations for the Assessment of Blend and Content Uniformity, Part 1: Modifications to Withdrawn FDA Draft Stratified Sampling Guidance”, Journal of Pharmaceutical Innovation, Volume 10, Issue 1, pp. 76-83. Co-Authored with Thomas Garcia, James Prescott, Ravindra Tejwani, Thomas Parks, Jon Clark, William Brown, Fernando Muzzio, Samir Patel, Charles Hoiberg, (March 2015)
“Recommendations for the Assessment of Blend and Content Uniformity. Part 2: Technical Discussion of Sampling Plans and Application of ASTM E2709/E2810”, Journal of Pharmaceutical Innovation, Volume 10, Issue 1, pp. 84-97. Co-Authored with James Prescott, Ravindra Tejwani, Thomas Parks, Jon Clark, William Brown, Fernando Muzzio, Samir Patel, Charles Hoiberg (March 2015)
“Current Events in Blend and Content Uniformity”, Pharmaceutical Engineering, Volume 34, Number 2, Co-Authored with Thomas Garcia, James Prescott, Ravindra Tejwani, Jon Clark, William Brown (March/April 2014)
“Lot Acceptance Procedure Criteria: Providing Statistical Confidence to Pass”, ASTM Standardization News, (Sep/Oct 2013)
“Application of Quality by Design(QbD) to the Development and Validation of Analytical Methods”, Chapter in Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Elsevier, Co-authored with D. Lloyd (September 2013)
"A Proposed Content Uniformity Test for Large Sample Sizes" Pharmaceutical Technology, Advanstar Communications, Co-authored with K Vukovinsky (November, 2010)
"Statistical Considerations in Design Space Development", Pharmaceutical Technology, Advanstar Communications, Co-authored with PhRMA CMC Statistics Expert Sub-Team, June, July, August (2010)
"Acceptance Limits for the New ICH USP 29 Content Uniformity Test", Pharmaceutical Technology, Advanstar Communications, 2007, 90-100, Co-authored with H. Li.
"Statistical Methods for Content Uniformity and Dissolution", Pharmaceutical Process Validation, Marcel Dekker, 2003, 667-698, Co-authored with M. Utter, edited by R. Nash
"Process Validation", Encyclopedia of Biopharmaceutical Statistics., Informa Healthcare, 2010, Co-authored with M. Utter, edited by S. Chow
"Common Challenges Facing Statisticians in Nonclinical Biostatistics", Biopharmaceutical Report, 1999, Vol. 7. No. 2
"Interchangeability of PVC Films and Aluminum Foils", Pharmaceutical Technology, Advanstar Communications, November 1997, 42-56, Co-authored with PhRMA Quality Work Group on Flexible Packaging Materials
"Bead Manufacture by Extrusion/Spheronization - A Statistical Design for Process Optimization", Drug Development and Industrial Pharmacy, 1993, 9(13), 1505-1519, Co-authored with C.Ku, Y.Joshi, and N. Jain
"Acceptance Limits For Multiple Stage Tests", Drug Development and Industrial Pharmacy, 1990, 16(14), 2153 - 2156.
Publications
James Bergum - Accomplishments
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