A Closer Look at Process Validation Stages 1 – 3, A Series

Extended Learning
Learning Level: Basic/Intermediate

Take a closer look at the three Stages of Process Validation, one of the most important and commonly misunderstood areas of the pharmaceutical industry. Following ISPE’s successful Process Validation webinar held in Spring 2020, our SME’s will give you a deeper dive into the stages of Process Validation – Process Design, PPQ and CPV in three separate webinar sessions. Register for one or all three to hear from renowned experts Bruce Davis and Line Lundsberg as they share practical examples and best practices in the application of the lifecycle approach. 

See below for a full description of each webinar - including the bundle offer available with a savings of 20% for all three webinars.

Learning Objectives

  1. Understand the process validation lifecycle and the importance of maintaining an effective pharmaceutical quality system
  2. Understand the challenges to the application of an entirely science- and risk-based approach
  3. Acquire tools to prepare for a smooth validation execution
Process Validation

 

  • Webinar 1: Process Validation: Stage 1 - Process Design: Learning

    Date: Tuesday, 15 December 2020, 1030 – 1200 ET

    Learn how Process Design enables product and process understanding and how Stage 1 links to the other PV stages (PPQ/PV and CPV/OPV).

    • Learn how to apply science and risk based principles for Stage 1 and discuss Stage 1 deliverables
    • Discover the QbD roadmap – from QTPP to Control Strategy
    • Learn the role and significance of Control Strategy in the PV lifecycle
    • Gain practical examples of Stage 1 deliverables for different product types

    $99 Members/$149 Nonmembers

    Can't attend? Still secure your spot as registration includes on demand access to a recording of the webinars for one year, giving you time to catch-up or re-watch!

    Register

  • Webinar 2: Process Validation: Stage 2 - Process Performance Qualification or Process Validation

    Date: Wednesday, 16 December 2020, 1030 – 1200 ET

    Learn how to evaluate and qualify the process designed in Stage 1 to ensure consistent and reliable levels of quality.

    • Understand how PV Stage 2 depends on information from Stage 1 and the link to Stage 3.
    • Apply science and risk-based principles
    • Explain how the Control Strategy evolves from development to commercial manufacturing
    • Understand how to summarize the outcome of PPQ/PV and propose a plan for Stage 3

    $99 Members/$149 Nonmembers

    Can't attend? Still secure your spot as registration includes on demand access to a recording of the webinars for one year, giving you time to catch-up or re-watch!

    Register

  • Webinar 3: Process Validation: Stage 3 - Continued Process Verification or Ongoing Process Verification

    Date: Thursday, 17 December 2020, 1030 – 1200 ET

    Learn how Continued or Ongoing Process Verification during the production of commercial produce ensures the process designed and qualified/validated continues to deliver consistent quality.

    • Understand how the three stages of Process are linked
    • Learn the role of statistical tools and how/when they are used
    • Ensure the application of QRM throughout Stage 3 as part of the overall product lifecycle
    • Learn how CVP/OPV reporting is carried out

    $99 Members/$149 Nonmembers

    Can't attend? Still secure your spot as registration includes on demand access to a recording of the webinars for one year, giving you time to catch-up or re-watch!

    Register

  • Webinar Bundle: Access to All Three Webinars - 20% SAVINGS

    With this exclusive bundle, you can access to all three webinars at a 20% savings! If you're not able to attend all three webinars, you will receive a link to the recording and PDF of the presentation to view on demand.

    Webinar 1: Process Validation Stage 1
    Tuesday, 15 December 1030 - 1200 ET

    Webinar 2: Process Validation Stage 2
    Wednesday, 16 December 1030 - 1200 ET

    Webinar 3: Process Validation Stage 3
    Thursday, 17 December 1030 - 1200 ET

    $238 Members/$358 Nonmembers

    Can't attend? Still secure your spot as registration includes on demand access to a recording of the webinars for one year, giving you time to catch-up or re-watch!

    Register


Individual webinars:  $99 Members/$149 Nonmembers
Webinar bundle: $238 Members/$358 Nonmembers - Savings of 20%

Can't attend? Still secure your spot as registration includes on demand access to a recording of the webinars for three months, giving you time to catch-up or re-watch!

Register

 

Speakers

Line Lundsberg-Nielsen, PhD
Managing Consultant, Compliance Consulting
NNE
Bruce S. Davis
Principal
BD Global Consulting