Zurich, Switzerland: +41 - 43 434 80 33   |   US: (510) 962-8903   |   support@traininng.com

Seminar Price Details

Seminar Fee for One Delegate
Price : US$799.00

Register for 5 attendees
Price : US$3,995.00

Register for 10 attendees
Price : US$7,990.00



**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Overview

This course will take you through the lifecycle of robust, accurate and precise relative potency assays, from inception, through regulatory compliant development, analysis, validation and performance monitoring. Statistical concepts will be explained and allocated to the relevant lifecycle stages, appreciating the difference between statistics users and statisticians. 

Areas Covered in the Session

  • Bio-pharmaceutical CMC, QC

Learning Objectives

Understand the continuum of bioassay method development. Appreciate that multiple operational and biological factors cause these assays to typically exhibit a greater variability than do chemically-based tests (and thus the need for control). Familiarization with the relevant (non-)statistical tools associated with the lifecycle of a method. Bridge the gap between scientist and statistician. 

Who Will Benefit

  • Biopotency assay developers from novice to intermediate/advanced
  • Relevant Regulatory Authorities
  • QC Scientists
  • QA Representatives

Agenda

Day 1 Schedule

Lecture 1: Scope

  • Focus
  • Bioassay versus Bioanalytical
  • Regulatory landscape
  • Statistics users versus statisticians

Lecture 2: Cellular substrate

  • Provenance
  • Control: sourcing, propagation, banking

Lecture 3: Uniformity of response

  • Functional read-outs
  • Heterogeneity characterization
  • Assay layout

Lecture 4: Method development

  • Knowledge space, design space
  • Design of Experiments (factorial designs, RSM designs)
  • Statistical assumptions

Lecture 5: Method development/optimization

  • Case study/ reiteration of the above

Lecture 6: Data Analysis

  • Statistical model choice
  • Assessing sample suitability (difference versus equivalence testing)
  • System suitability (setting boundaries and assessment of)

Lecture 7: Validation/ Qualification

  • ICH Q2(R1) versus USP<1033>

Lecture 8: Continual validation

  •  Use of statistical process control charts

 

Day 2 Schedule

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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!

Dr. Zeban Kolen 

Associate Director,
Biological Assays at Synthon


Dr. Zeban Kolen, is Associate Director biopotency assays at Synthon Biopharmaceuticals BV. Dr. Kolen conducted his PhD at the Laboratory of Hematology of the Radboud University Medical Center, Nijmegen, The Netherlands, where he studied chimerism in haematopoietic reconstitution after allogeneic stem cell transplantation and donor leukocyte infusions. He then joined Synthon BV, and was involved in the start-up and successful fruition of Synthon’s Biopharmaceutical ambitions, with a growing portfolio in oncology and autoimmune diseases.

During his career he has gained expertise with development and validation of robust and fit for purpose potency assays, applying analytical quality by design (aQbD) concepts. The latter is strengthened by his interest in process improvement and acquisition of a Six Sigma Black Belt. Statistical thinking and concepts have been a main focus in leading his group at Synthon Biopharmaceuticals, and a main principle taught during his trainings/seminars.

Venue

Location: Zurich, Switzerland
Hotel: Hilton Zurich Airport