Qualification Sample Size and Statistical Confidence for Pharma Process Performance Qualification (PPQ)

Instructor: Marvin Iglehart
Product ID: 703579
Training Level: Advanced
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This webinar will discuss the requirements and general expectations for Stage 2 – Process Qualification, the key concepts that lead to the basis of confidence level and/or statistical confidence and how to apply the concepts in practical use for validation, including acceptance criterion.

Why Should You Attend

This 90-minute session will provide an overview of Stage 2 – Process Validation - using practical examples that you can apply when validating your products. We will discuss the approaches and statistical calculations required to execute Stage 2 – Process Qualification - based upon statistical confidence. The instructor will provide examples for practical application of the determination of sample size, confidence, and process capability when balancing risk. You will learn how to connect the guidance and requirements for statistical confidence to statistical rationale, deliverables, and validation acceptance criterion that can stand the challenge of an audit.

Areas Covered in the Webinar:

  • Overview of FDA Guidance
    • Process Capability
    • Process Stability
  • Definitions and Concepts that Lead to the Basis of Confidence Level and Statistical Confidence
    • Confidence Level
    • Risk and Confidence Level
    • Example Confidence Equations
    • Application of ASTM E2281-08a (2012) Standard Practice for Process and Measurement Capability Indices
  • Minimum Batches vs Confidence Level
  • Statistical Rationale Examples
  • PPQ Examples including Acceptance Criterion with Statistical Confidence

Who Will Benefit:

This webinar is targeted mainly to manufacturers of pharmaceutical products and biopharmaceuticals. The personnel who will benefit include:

  • Validation Managers
  • Validation Engineers
  • QA and Auditing Professionals
  • Regulatory Professionals
  • Scientists
  • Product, process and formulation development
  • Personnel in analytical development

Instructor Profile:

Marvin Iglehart, SSMBB has over 15 years of combined Compliance, Quality Systems and Quality Assurance experience related to FDA cGMP’s, Part 820, Parts 210/211, Q10, GLP’s, Part 11, ISO 13485, & ISO 1497. He currently is the Principal Consultant of Quality Systems and Continuous Improvement (QS&CI) Consulting, LLC, where he provides consulting and training services to medical device and pharmaceutical companies. Prior to QS&CI Consulting, LLC, he has worked in Quality Leadership, Quality Management or Engineering with B. Braun Medical, St. Jude Medical, Welch Allyn Monitoring, Bausch & Lomb, Playtex Products, Sherwood Medical, Baxter Healthcare Corporation. As a consultant, Marvin has provided his expertise to Alcon Laboratories, Inc., Synthes, and Wright Medical.

Marvin has a MS degree in Mechanical Engineering from the Georgia Institute of Technology where he also received a certificate in Computer Integrated Manufacturing Systems (CIMS). He is a certified Six Sigma Master Black Belt with over ten years of experience in continuous improvement, project management, quality engineering, manufacturing process controls, process validation, computer/software verification and validation, and regulatory.

Marvin has authored several technical publications and has presented compliance and quality topics at several conferences. He is currently a member of ASQ.

Topic Background:

The demonstration of process capability and process stability poses some challenges for some manufacturers of Pharma products as they transition from Stage 1 – Process Design to Stage 2 – Process Qualification including that Stage 2 – Process Qualification applies to both new product launches and legacy products under change control.

The FDA and ISPE have provided the following three key references to sort through requirements and expectations:

  1. FDA January 2011 Guidance for Industry, Process Validation: General Principles and Practices (for Pharmaceutical)
  2. FDA September 2011 presentation: Process Validation Guidance "What Does "Statistical Confidence" mean
  3. ISPE Topic 1 - Stage 2 Process Validation: Determining and Justifying the Number of Process Performance Qualification Batches

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