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PDA 281 Economical Design of Lyophilization Experiments

May 06, 2022
Bethesda, MD

  • Education
  • The Americas
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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, Chemical Eng & M.S. Applied Statistics, has worked in the pharmaceutical industry since 1999. He is the Principal Statistician at PharmStat, which he started in 2010. Most recently he consulted with the World Health Organization on implementing QbD in vaccine manufacturing development.  He specializies in CMC statistics and the design of experiments 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. Areas of expertise include Sampling, 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  parenterals, solid oral dose, capsues, biotechnology, fine chemicals, medical devices, food, and nanotechnology.

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

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

    Departments
    Quality Control (Analytical), Quality Systems, Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations, Research and Development, Regulatory Affairs, Technical Operations, Training, Validation

    Roles
    Operator/Technician, Supervisor, Manager, Director, Engineer, Scientist, Auditor/Inspector

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Travel

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PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The following airports are near the training course location: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please take your car with you once the training course has ended. After 18:00 hours, you will not be able to access the building or parking garage from the outside.

Other Options

Metro: Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location. Amtrak: Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

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Registration Fees

Early Registration
Registration Type Price By March 22, 2022
Member $899
Non-member $1,079
Gov't/Health Auth./Academic* $699

Regular Registration
Registration Type Price After March 22, 2022
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699

* 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.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

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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