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Economical Design of Lyophilization Experiments Workshop

May 04, 2020
Carlsbad, CA

  • 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 Course Series

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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

  • Accreditation

    Accreditation

    PDA is on probation as an accredited provider of continuing pharmacy education by the Accreditation Council for Pharmacy Education.
    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: 281 / 0116-0000-19-062-L04-P / 0.6
    Type of Activity: Application

    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 6 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 6 PDH credits.

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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

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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 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).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by Apr 04, 2020, no fee will be charged. After Apr 04, 2020, 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 by Apr 04, 2020, a full refund will be given minus a $200 fee. After Apr 04, 2020, 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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Tel: +49 (0) 30 43 655 08-10

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