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Economical Design of Lyophilization Experiments Workshop

May 04, 2020
Carlsbad, CA

  • Education
  • The Americas
Closed

Overview

Using lecture, computer workshop, and webinar, this training course is an applied introduction to an economical Design of Experiments (DoE) approach using lyophilization as the case study.

Attendees will:

  1. Collaborate to design an experiment to demonstrate that a fully developed freeze drying process is little affected by the presence of variation in critical process parameters (CPP) and that the critical quality attributes (CQA) meet their specification criteria.
  2. Analyze a provided DoE data set using the computer (attendees can bring their own software or a free trial version of Minitab can be provided).

In contrast to the common burdensome and wasteful approach, this training course will focus on the economy of the DoE and give a practical experience of the process to create the attendees’ own experiments and reports.

For more options and/or related training courses, please visit the page(s) below.

PDA Lyophilization Training Courses

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Agenda

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  • Training courses generally run from 8:30 to 16:00 each day. Breakfast will not be provided, but lunch will be provided.

Trainers

Jason J. Orloff
Jason J. Orloff
PharmStat
Bio
Jason J. Orloff
PharmStat

Jason J. Orloff, Ch.E. & M.S. Applied Statistics is the Principal Statistician at PharmStat. Most recently he consulted with the World Health Organization on QbD in parenteral manufacturing development. He is an international consultant specializing in applied statistics and experimental design for pharmaceutical and biopharmaceutical 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. Mr. Orloff brings over ten years of experience in manufacturing, quality, and regulatory affairs in the pharmaceutical industry. 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, Mr. Orloff is able to work effectively across all levels of an organization as well as make high level concepts accessible to a variety of audiences. Mr. Orloff 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 UW-Madison and an MS degree in Applied Statistics from DePaul University.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Demonstrate a working understanding of economical approaches to DoE which can be shared with their work group
    2. Explain how to do more with the same investment or less
    3. Identify the process variables and process steps of freeze drying and their criticality to develop a strategy for qualification, validation, annual product review, and discrepancies
    4. Connect statistical concepts to federal and ICH regulations
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in economical design of experiments.

    Departments
    Engineering, Manufacturing, Quality Assurance, Quality Control, Quality Systems, Quality Compliance, Regulatory Affairs, Research and Development, Training, Validation

    Roles
    Auditor, Consultant, Director, Engineer, Manager, Operator, Scientist, Supervisor, Technician

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Travel

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Open Biopharma Research and Training Institute

1958 Kellogg Avenue
Carlsbad, CA

How to Get Here

By Air

The nearest airport to the training course location is the San Diego International Airport (SAN).

By Car

There is a parking lot available at the training course location.

Other Options

N/A

Directions

Registration Fees

Early Registration
Registration Type Price After March 20, 2020
Member $1,259
Non-member $1,511
Gov't/Health Auth./Academic* $979

Regular Registration
Registration Type Price After March 20, 2020
Member $1,399
Non-member $1,679
Gov't/Health Auth./Academic* $979

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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