Assay Validation by Design - New Course

Bethesda, MD
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

Pharmaceutical assay validation is both a good business practice and a requirement of the current Good Manufacturing Practice Regulations. This introductory course presents assay validation as specified in the ICH guidelines, USP, FDA documents and the literature.

Completion of this course will enable participants to plan, design and analyze data collection protocols to develop and improve chemical assays while also collecting the data needed to validate to the USP and ICH requirements. Additionally, participants will be able to design, execute, and report a statistically consistent validation of an analytical method including considerations such as accuracy, precision, specificity, limit of detection/limit of quantitation/linearity and range, and robustness and ruggedness.

Who Should Attend

This introductory seminar is for those working in chemical assay validation. It is intended for analytical laboratory chemists, supervisors and managers. Validation engineers, quality control/assurance personnel and others with an interest or responsibility for validation will likewise benefit.


It is recommended that the participant read ICH Q2 (R1).

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Design an assay validation that uses Plackett-Burman DoE’s to demonstrate ruggedness with fewer experiments than the typical assay validation runs
  • Identify the sources of variation in a method
  • Quantify the best case and a worst level of variation
Agenda is subject to change.

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PDA Training and Research Institute

4350 East West Highway
Bethesda, MD , United States

Jason J. Orloff, Statistical & Engineering Consultant, PharmStat

Jason J. Orloff, Ch.E. & M.S. Applied Statistics is a Principal Statistical Consultant at PharmStat and a proud colleague of Lynn Torbeck. He is an international consultant specializing in applied statistics and experimental design for pharmaceutical and biopharmaceutical development, quality assurance, quality control, validation, and production under the cGXP's. Current activities include an author of ISPE’s Baseline Guide for Q10 chapter “Process Performance and Product Quality Monitoring”, contributing authorship of the PDA’s Technical Report 59 on “Utilization of Statistical Methods for Production and Business Processes”, and publications in the Journal of Pharmaceutical Technology. Mr. Orloff brings over ten years of experience in manufacturing, quality, and regulatory affairs in the pharmaceutical industry. Areas of expertise include PAT, OOS, SQC, SPC, assay validation and setting specification criteria. A Chemical Engineer with real-life expertise at applying statistics in a highly regulated environment, Mr. Orloff is able to work effectively across all levels of an organization as well as make high level concepts accessible to a variety of audiences. Mr. Orloff has worked with a wide variety of companies including pharmaceuticals, parenterals, biotechnology, fine chemicals, medical devices, food, and nanotechnology. He holds a BS in Chemical Engineering from UW-Madison and an MS degree in Applied Statistics from DePaul University.