How To Establish The Number of Runs Required For Process Validation


During process validation, setting your “number of runs” is critical to establishing defensible efforts in the eyes of regulators.  This session will give you the tools to tailor that number, plus provide best practices.  You will also receive helpful job aids for use long into the future.




Companies in the FDA-regulated industries frequently have validations with inadequate justification for the number of runs used for process validations. The “rule of three” batches (or runs) is a process typically used by FDA regulated industries for QC testing, process qualification (PQ) runs and process performance qualification (PPQ).

The FDA’s Process Validation: General Principles and Practices (2011) guidance document states that “The number of samples should be adequate to provide sufficient statistical confidence of quality both within a batch and between batches. “  Therefore, defaulting to a general “rule of three” should not be taken as gospel.  A tailored approach to establishing the number of runs is critical to achieving the best results.

During this session, we will instruct you on how to pinpoint an adequate number of runs for process validation, and introduce best practices for “getting there” and common pitfalls to avoid.


During the presentation, you will learn about:

  • Requirements for validation activities required by certification standards and federal regulations
  • Background information around FDA 483 findings and warning letters related to process validation
  • Linkage of validation and risk management activities
  • Variable and attribute sampling techniques
  • Techniques for establishing and justifying the number of validation runs
  • The use of non-parametric tests for means and variance to demonstrate statistical confidence of quality between batches


This course will be of benefit to anyone involved in process validation activities, and will provide guidance for people writing, executing, and summarizing validation protocols and reports.  Additionally, those who need to be able to audit process validation activities for compliance will find this course extremely beneficial.



This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.


Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.


Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

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