Statistical Methods Across the Product/ Process Lifecycle

    19 – 21 June 2023, live online training


    The use of statistical methods across the product lifecycle has steadily increased since the adoption of ICH Q8 and publication of regulatory guidance’s for lifecycle process validation. This increase does not simply meet regulatory expectation; these methods are good business practice no matter what the product. In this 3 day course participants will learn the typical sampling and statistical methods to use across the product lifecycle to: identify optimal operating regions and inform the control strategy (enable QbD), determine acceptance criteria, demonstrate the process is capable of reproducible commercial manufacture, provide evidence of ongoing process control and respond proactively to process changes.

    Learning Objectives

    • The most common and powerful statistical methods and their primary sue across the product lifecycle
    • The relationship of statistical methods and Quality Risk Management (QRM)
    • Key reasons to use Deign of Experiments (DOE) for process development
    • Modelling populations to assure quality
    • Difference between hypothesis testing and equivalence testing for comparability
    • Understanding the components of a sampling plan and associated acceptance criteria for Process Validation batches
    • Distinguish between intra- and inter- batch variability and methods to assess each
    • Elements and nuances of an Ongoing Process Verification (OPV) Program
    • Combination of root cause analysis with data visualization to speed root cause identification

    Key Topics

    • Integrating data analytics to accelerate development, improve processes and reduce risk
    • Ensure Quality by Design and Optimal Control Strategy
    • Sampling and Acceptance Criteria
    • Establishing comparability with equivalence testing
    • Identifying Relative contribution of sources of variability
    • Data visualization
    • Ensuring ongoing quality

    Who should attend?

    Process Validation, Process Development, Manufacturing Science and Technology, Process Improvement, Quality Assurance, Data Scientist, CMC Statistician, Technology Transfer

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 30 days
    • Training in digital format
    • Digital and LinkedIn certificates


    Tara Scherder
    Tara Scherder has over 20 years’ experience in the pharmaceutical and biopharmaceutical industries as a statistician, engineer, and master black belt. Her passion is the powerful combination of science and statistics to increase knowledge, optimize both manufacturing and business processes, and reduce risk.

    Statistical Methods Across the Product/ Process Lifecycle

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 023 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate

    Price per delegate including:

    Online participation

    Online workbook & materials

    Recorded sessions for 30 days


    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori
    +421 222 200 543

    Training Details
    • Start Date
      19. June 2023
      01:30 PM Vienna time
      12:30 PM London time
      07:30 AM New York time
      04:30 AM Los Angeles time
    • End Date
      21. June 2023
    What participants said about this course

    "One of the best online educations."
    Biostatistician, CSL Seqirus

    "The interaction and comunication with the participants very really useful. Thank you. Validation Engineer"
    CSL Behring

    "The discussion about EMA and FDA guidelines was interesting."
    Process Manager, Rentschler Biopharma

    "It was very good that the trainer provided a lot of practical examples."
    R&D CMC Manager, Mabxience

    "I really appreciated how Tara had plenty of experience and it very much showed. In addition, I loved how the class very much focused on realistic application rather than the theoretical aspects."
    Head of CMC Statistics, Novavax