DoE Basics for Validation by Design

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.

Who should attend?

Research & Process Development
Manufacturing & Technical Operations
Analytical Development
Regulatory Affairs
Quality Assurance / Quality Control

Specific Job Functions:
  • Manager / Leader / Supervisor
  • Researcher / Technician
  • Strategists & Auditors

Learning Objectives

At the completion of this course, participants will have the ability to:
  • Select appropriate, cost effective designs.
  • Efficiently identify and communicate cause and effect relationships.
  • Demonstrate the five step method to design studies.
  • Calculate main effects and multifactor interaction effects.
  • Plot graphs for main effects and interaction effects.
  • Test normallity at a glance, interpret, and communicate the results.
  • Explain the pitfalls and opportunities of confounding effects.
Event Location
Sofitel Berlin Kurfürstendamm
Augsburgstrasse 41, Berlin, Germany Get Directions

Contact

Program Inquiries
Exhibition/Sponsorship Inquiries
Christopher Haertig
Training Course Inquiries
[email protected]
Registration Customer Care

More information coming soon.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

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

Instructor

Jason J. Orloff, Chemical Engineer & Statistician, PharmStat
Jason J. Orloff, a chemical engineering applied statistician, is principal statistical consultant at PharmStat. An international consultant, he specializes in applied statistics and experimental design for development, quality assurance, quality control, validation, and production under the cGXP’s. Current activities include an author of ISPE’s Baseline Guide for Q10 chapter “Process Performance and Product Quality Monitoring”, contributing authorship of the PDA’s Technical Report 59 on “Utilization of Statistical Methods for Production and Business Processes”, and publications in the Journal of Pharmaceutical Technology. Jason brings twenty years of experience in pharmaceutical manufacturing, quality, and regulatory affairs. Areas of expertise include PAT, OOS, SQC, SPC, assay validation and setting specification criteria. A Chemical Engineer with real-life expertise at applying statistics in a highly regulated environment, Jason is able to work effectively across all levels of an organization as well as make high level concepts accessible to a variety of audiences. Jason has worked with a wide variety of companies including pharmaceuticals, parenterals, biotechnology, fine chemicals, medical devices, food, and nanotechnology. He holds a BS in Chemical Engineering from UWMadison and an MS degree in Applied Statistics from DePaul University.

Thursday, 28 September 2017

9:00
Welcome

Instructor Lead discussion on DoE fundamentals from management's role to ensure that funds are spent most efficiently for the good of the corporation to the researcher's responsibility to deliver actionable outcomes within budget and on time.
10:30
Coffee Break

11:00
Examples of the prioritization of resources through risk assessment will be introduced using Japan's National Institute of Health Sciences, Sakura, and the PDA's iVAX case studies.

The incremental change to traditional scientific methods will be explored in the Pharmaceutical context.

12:30
Lunch Break

13:30
Both a classical and a fractional factorial study will be designed by hand using "an intern's plastic syringe extrusion project" as a start point.

Basic concepts using only addition, subtraction, and division

15:30
Coffee Break

16:00
Both a classical and a fractional factorial study will be designed by hand using "an intern's plastic syringe extrusion project" as a start point.

Basic concepts continued – no computers necessary.

18:00
End of Day 1

Friday, 29 September 2017

9:00
The way you present the data influences how we think about the data: Analysis using Graphical Tools
10:30
Coffee Break

11:00
Numerical Analysis: "If you doubt it, count it." ~ Francis Galton

Understanding & Presenting Results

12:30
Lunch Break

13:30
Pharmaceutical Case Studies from 30 years of Scientific Literature

15:00
Coffee Break

15:30
Case Studies continued (Placket Berman Designs for validation as time permits)
16:30
End of Training Course
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.

Sofitel Berlin Kurfürstendamm

Augsburgstrasse 41
Berlin, Germany , Germany
Exterior

Sofitel Berlin Kurfürstendamm
Augsburger Strasse 41
10789 Berlin
Germany
Tel: +49 30 800 999 0
Fax: +49 30 800 999 99
Hotel Website
Email

Just 100m from the Kurfürstendamm Boulevard, Sofitel Berlin Kurfürstendamm has a strikingly modern architecture with its spacious rooms and suites featuring dark woods and high windows.

Restaurant Le Faubourg offers traditional French cuisine and an outdoor terrace overlooking Kurfürstendamm.

Formerly the Hotel Concorde Berlin, the Sofitel Berlin Kurfürstendamm provides a touch of luxury in an Art Deco building. It is near designer boutiques, cultural highlights, the KaDeWe department store, Berlin Zoo, the Theater des Westens, Charlottenburg Palace and the Deutsche Oper Opera House.

Kurfürstendamm Underground Station is just a 3-minute walk from the Sofitel. Buses run directly to Tegel Airport from there.

PDA Europe has reserved a limited number of rooms until the 17th August 2017.

for the PDA Group Rate.

Single Room € 165 per night*
Double Room € 185 per night*

*Rates are per room and night, including the following services and benefits:

  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (Wi-Fi)
  • On-site Parking
  • Taxes and Service will apply

How to Get There

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 6091 1150
Hotel distance: 13 km

  • Bus service, fee: € 2.80 (one way)
  • Estimated taxi fare: € 26

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 6091 1150
Hotel distance: 23 km

  • Bus service, fee: € 3.40 (one way)
  • Estimated taxi fare: € 48

Photos