ARTICLES BY MARK DURIVAGE

• FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities

  5/3/2021

  On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.

• Integrating Risk Management In The Quality Management System — A Primer

  4/7/2017

  This article will first present the definitions and requirements regarding risk and then introduce some tools that can be utilized to incorporate and integrate risk management techniques in and throughout the QMS.

• How To Establish Sample Sizes For Process Validation Using LTPD Sampling

  12/27/2016

  The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of lot tolerance percent defective (LTPD) to establish sample sizes for process validation.

• How To Establish Sample Sizes For Process Validation Using Variable Sampling Plans

  11/28/2016

  The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of variable sampling plans to establish sample sizes for process validation.

• How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem

  7/19/2016

  This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.

• Risk-Based Approaches To Establishing Sample Sizes For Process Validation

  6/14/2016

  Using confidence, reliability, and acceptance quality limits (AQLs) to determine sample sizes for process validation are proven methods to ensure validation activities will yield valid results based upon an organization’s risk acceptance determination threshold, industry practice, guidance documents, and regulatory requirements.