Design of Experiments (DoE) - The Basis of Validation

Berlin, Germany
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If done right, DoE should cost as much or less than the traditional approach to pharmaceutical development. This two-day course is a practical introduction to experimental design basics with applications to research, process assay development, and validation. A non-theoretical approach presents the concepts using arithmetic and simple graphics to understand and communicate your understanding of multifactor interactions.

World Health from FDA 2011 Process Validation Guidance to ICH Q8 requires the study of multivariate interactions.The Design of Experiments is how to do this.

The Quality By Design approach can either be budget crushing, time pushing additions at the end of development or it can be a cost saving tool built into the fabric of your organization with which to balance the quality of theinformation gained against the time its going to take and the resources available before committing any monies to a project.

Agility and flexibility in the pharmaceutical industry requiresthe ability to manage complex post-approval change. The design of experiments is one such framework within which to capture,expand upon, and communicate knowledge.

This class looks at DoE strategy and introduces more advancedtechniques for both understanding variation and demonstrating that the commercial process is capable of producing quality product.

More information coming soon.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1


Jason Orloff,Principal Statistical Consultant, PharmStat

Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hotel am Steinplatz
Steinplatz 4
10623 Berlin
Tel: +49 30 554444 0
Fax: + 49 30 55 4444 6023

Highly acclaimed as a recipient of many distinguished awards, Hotel am Steinplatz, showcases stunning design and authentic, intuitive service in an atmosphere blending history and lifestyle.

The boutique hotel has welcomed guests to West Berlin's affluent Charlottenburg district for over 100 years and after a recent extensive renovation in our historic Art Nouveau building, we continue to provide a truly unparalleled and charming experience for our visitors. Our 84 guest rooms and three suites are brimming with boutique style details to provide an intimate, private atmosphere.

PDA Europe has reserved a limited number of rooms until the 01 February 2016.

Book your room for the PDA Group Rate.

Single Room 169€ per night
Double Room 189€ per night
including breakfast, VAT, WLan and Service Charge – City tax applies.

How to get there

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel direction: 5.2 miles SE

This hotel does not provide shuttle service

  • Alternate transportation: Black Lane Limousines; fee: 55 EUR (one way) ;on request
  • Bus service, fee: 2.6 EUR  (one way)
  • Estimated taxi fare: 20 EUR  (one way)

Berlin-Schoenefeld International Airport - SXF
Hotel direction: 14.3 miles S

This hotel does not provide shuttle service

  • Courtesy phone available
  • Bus service, fee: 2.6 EUR  (one way)
  • Subway service, fee:  2.6 EUR  (one way)
  • Estimated taxi fare: 40 EUR  (one way)


  • On-site parking, fee: 3.50 EUR hourly, 25 EUR daily
  • Valet parking, fee: 3.50 EUR hourly
  • Off-site parking, fee: 3.50 EUR hourly, 25 EUR daily