Risk-Based Approaches To Establishing Sample Sizes For Process Validation

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Date: February 16, 2017
Time: RECORDED SESSION
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Register for this session and be entered to win a copy of Mark Durivage’s book “Practical Process Validation,” a $70 value!

Course Description:

Companies in FDA-regulated industries frequently perform validations with inadequate sample sizes or otherwise without satisfactory statistical justification. This is due, in part, to engineers being thrown into the quality function without proper training, or being trained to follow the disastrous “this is the way we have always done it” model.  The bottom line is this: Validation sample size matters…and inadequate efforts will almost certainly result in global regulatory observations and/or product failures.

This presentation is intended to provide and guidance for people writing, executing, and summarizing validation protocols and reports. During the presentation, you will learn about:

  • Requirements for validation activity mandates found in certification standards and federal regulations
  • Background information compiled from FDA Form 483 findings and warning letters related to process validation
  • Linkage of validation and risk management activities
  • Variable and attribute sampling techniques
  • Continuous process monitoring

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

Mark Allen Durivage is the Managing Principal Consultant at Quality Systems Compliance LLC and an author of several quality-related books including;

  • Practical Process Validation (ASQ Quality Press, 2016)
  • Practical Engineering, Process, and Reliability Statistics (ASQ Quality Press, 2014)
  • Practical Attribute and Variable Measurement Systems Analysis (MSA) (ASQ Quality Press, 2015)
  • Practical Design of Experiments (DOE) (ASQ Quality Press, 2016)

He earned a B.A.S in Computer Aided Machining from Siena Heights University and a M.S. in Quality Management from Eastern Michigan University. Durivage is an ASQ Fellow and holds several ASQ certifications including; CQM/OE, CRE, CQE, CQA, CHA, CBA, CPGP, and CSSBB. He also is a Certified Tissue Bank Specialist (CTBS) and holds a Global Regulatory Affairs Certification (RAC). Durivage resides in Lambertville, Michigan.