DoE Basics for Validation by Design
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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
- 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.
Agenda
Discover What's Happening Each Day
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
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9:00 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 |
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11:00 The incremental change to traditional scientific methods will be explored in the Pharmaceutical context. |
| 12:30 Lunch Break |
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13:30 Basic concepts using only addition, subtraction, and division |
|
15:30 |
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16:00 Basic concepts continued – no computers necessary. |
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18:00 |
Friday, 29 September 2017
|
9:00 |
| 10:30 Coffee Break |
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11:00 Understanding & Presenting Results |
|
12:30 |
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13:30 |
| 15:00 Coffee Break |
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15:30 |
| 16:30 End of Training Course |
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Venue Details and Accommodations
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 41Berlin, Germany Germany
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
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Registration
Pricing Options
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.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Sponsorship and Exhibit Opportunities are Available!
For more information about exhibit and sponsorship opportunities, please contact:
Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email
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