Training Seminars

WEDNESDAY, APRIL 10 - THURSDAY, APRIL 11
DAY 1: 8:30 AM - 5:45 PM | DAY 2: 8:30 AM - 12:30 PM (Washington)

TS11B: STATISTICS 101 FOR ASSAY VALIDATION

DAY 1: WEDNESDAY

8:30 am - 5:45 pm Seminar Sessions

12:30 - 1:30 pm Lunch Provided

5:45 - 7:00 pm Reception

DAY 2: THURSDAY

8:30 am - 12:30 pm Seminar Sessions


Exhibit Hall Refreshment Breaks also provided.

Instructor:

Perceval Sondag, Senior Manager, Statistics, PharmaLex


This training first covers all the basic statistical concepts that are required to perform a successful assay validation, such as (non)linear models for calibration, variance component analysis, and design of experiments. We will then discuss some regulatory requirements for assay validation and discuss how to ensure regulatory compliance while also guaranteeing that the assay is fit for its intended purpose. Finally, we will combine those statistical and regulatory concepts in a case-study.

Topics to be Covered Include:

  • Regulatory requirements for assay validation
    • FDA
    • ICH
    • USP
  • Statistical concepts for assay validation
    • Understand ‘variance component’ analysis
    • Statistical tools for assay validation
    • Total error approach
  • All-in-one design
    • One set of experiment to answer every validation question

Instructor Biography:

Sondag_PercevalPerceval Sondag, Senior Manager, Statistics, PharmaLex

Perceval Sondag holds a Bachelor Degree in Physical Therapy and a Master’s Degree in Biostatistics, both obtained from the Catholic University of Louvain-la-Neuve in Belgium. After starting his career by implementing statistical thinking in the newly created Operational Excellence department of the Brussels Saint-Luc University Hospital.

He joined Arlenda in 2013 as a Statistician consultant, and moved to the US based team in 2015. He specializes in Bayesian modelling and statistics applied to bioassays and process manufacturing. In addition to his job at Arlenda, providing statistical support for small and big pharmaceutical companies across the globe, he currently works on a PhD thesis about Similarity Testing for Bioassays. He is a member of the USP Expert Panel for Bioassays and has authored or co-authored multiple publications, including a book chapter on assay validation.

What is a Training Seminar?

Each Training Seminar offers 1.5 Days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed no additional books will be available.

Though CHI encourages track and symposia hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and NOT engaging in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.


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