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DoE Basics for Validation by Design

Sep 28 - Sep 29, 2017
Berlin, Germany

This two-day course is a practical introduction to experimental design basics with applications to research, process & assay development, and validation.

  • Education
  • Europe

Overview

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.

Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Travel

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

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

4 Ways to register

  • Online Registration
  • FAX: +49 30 436 55 08 66
  • [email protected]
  • Mail: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1495 Euro

All fees given in Euro and excluding VAT (7%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900
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