Login Register
Life Science Training Institute
  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
      • R&D
      • Leadership & Training
    • eLearning
      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
    • LSTI Learning Library
    • Training Voucher Packages
    • Checkout
  • Custom Training
    • Live Training
    • Elearning Solutions
    • LSTI Corporate Learning Library
    • CRA Academy
  • Articles & Resources
  • About LSTI
    • LSTI Leadership
    • LSTI Instructors
    • Contact Us
    • Connect with LSTI
    • Frequently Asked Questions
  • Connect
  • WEBINARS/eLEARNING
    • Live Courses/Webinars
    • On-Demand Courses/Webinars
    • By Category
      • Clinical Trials (GCP)
      • Manufacturing
      • Medical Devices
      • Regulatory
      • R&D
      • Leadership & Training
    • eLearning
      • Clinical Pathways
      • DIGR-ACT: Critical Thinking Skills for Clinical Trials
    • LSTI Learning Library
    • Training Voucher Packages
    • Checkout
  • Custom Training
    • Live Training
    • Elearning Solutions
    • LSTI Corporate Learning Library
    • CRA Academy
  • Articles & Resources
  • About LSTI
    • LSTI Leadership
    • LSTI Instructors
    • Contact Us
    • Connect with LSTI
    • Frequently Asked Questions
  • Connect
HomeManufacturing & Good Manufacturing Practices (GMP) TrainingHow To Establish The Number of Runs Required For Process Validation

How To Establish The Number of Runs Required For Process Validation

Teachers
Mark Allen Durivage
Category:
Manufacturing & Good Manufacturing Practices (GMP) Training/ On-Demand Courses/ Regulatory & Compliance/
Clear

— OR —

Duration: 60 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

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.

LEARNING OBJECTIVES

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

Who Should Attend

WHO SHOULD ATTEND

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.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

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.

THE TRAINING PLATFORM

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.

USER AGREEMENT

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.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800, option #3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Mark Allen Durivage
Lead on-site quality inspections at facilities throughout the North America, Europe, and Asia for a $4.5B manufacturer of orthopedic products and instruments.

There are no reviews yet.

Be the first to review “How To Establish The Number of Runs Required For Process Validation” Cancel reply

Clear

— OR —

Duration: 60 minutes
On-Demand
Includes handouts

CATEGORIES

  • Coronavirus / COVID-19 (4)
  • Clinical Trials & Good Clinical Practices (GCP) Training (110)
  • Introductory Pharma Courses (18)
  • IT & Data Integrity for Pharma (33)
  • Leadership & Training (40)
  • Manufacturing & Good Manufacturing Practices (GMP) Training (92)
  • Medical Device Training (63)
  • On-Demand Courses (239)
  • Quality (52)
  • Regulatory & Compliance (208)
  • Research & Development (80)
  • Special Packages (5)

Upcoming Live Courses

  • China GCP 2020: Understanding and Implementing New Compliance Requirements
  • How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer
  • It is Finally Here! Update to the ISO Medical Device GCP Standard: ISO 14155:2020
  • Preparing for Changes to ICH GCP E6(R3) and ICH E8(R1) – Readying for Risk Mitigation

TOPICS

Cleaning Validation Cleanroom Clinical Trials Cloud CMOs Computer Systems CRAs CROs Data Integrity Device eCTD EHRs EMA Equipment Facilities FDA GCP GDP GLP GMP HIPAA Human Error ICH Informed Consent Inspections Instructional Design Management manufacturing Marketing MDR microbial control Process Validation Project Management QMS Quality Quality by Design Quality Risk Management Remote Monitoring Risk Risk-Based Monitoring Root Cause Analysis Site Monitoring SOPs Training Trial Master File

Your Courses

About Us

The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

EMAIL COMMUNICATIONS

Get LSTI Email Communications straight to your inbox. Sign Up Here

Contact Us

  • 19 W College Ave. Ste 300, Yardley, PA 19067
  • +1-267-274-5133
  • info@lifesciencetraininginstitute.com

Course Categories

  • Clinical Trials & Good Clinical Practices (GCP) Training
  • Coronavirus / COVID-19
  • Introductory Pharma Courses
  • IT & Data Integrity for Pharma
  • Leadership & Training
  • Manufacturing & Good Manufacturing Practices (GMP) Training
  • Medical Device Training
  • On-Demand Courses
  • Quality
  • Regulatory & Compliance
  • Research & Development
  • Special Packages

Meet Our Instructors

Footer logo
Copyright © 1996 - 2021 Red Nucleus Solutions, LLC. All Rights Reserved.
  • Webinars
  • Custom Training
  • About LSTI
  • Privacy
  • Terms
Search