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Fundamentals of Lyophilization

May 06 - May 07, 2019
Bethesda, MD

  • Education
  • The Americas
Closed

Overview

This training course will help you gain an understanding of the basic principles and practical aspects of lyophilization technology.

During this training course, you will learn about cycles and equipment, vacuum technology use for freeze drying, sublimation in primary drying, desorption during secondary drying, application of principles to product and process development, analysis of product characteristics, and process scale-up to production. Attendees will have a general overview and working knowledge for practical application in development, production, and evaluation of lyophilized parenterals.

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Agenda

  • An agenda will be provided on the first day of the training course.

Trainers

Edward Trappler
Edward Trappler
Lyophilization Technology, Inc.
Bio
Edward Trappler
Lyophilization Technology, Inc.

Ed Trappler is president and founder of Lyophilization Technology, Inc. a contract research and technical services firm dedicated to freeze drying. He has over 30 years experience in lyophilization that ranges from product development to equipment application engineering. He received his Bachelor of Science degree in chemistry at The College of New Jersey. His experience in the pharmaceutical industry includes product development, toxicology supply preparation, clinical manufacturing and parenteral production.

He began his career in 1976 as a development technician in Product Development at Elkin-Sinn Inc. in Cherry Hill, New Jersey. He was later promoted to Production Supervisor in charge of start-up for prefilled syringe and lyophilization operations. He then joined McNeil Pharmaceutical, one of the Johnson & Johnson companies, as a Technical Associate in the Toxicology and Clinical Material preparation group. In 1984 he joined the Hull Corporation as a Systems Application Engineer until founding the company in 1992.

Ed has contributed chapters to six books, authored and presented numerous papers and courses in freeze drying in the United States, Canada, Europe, Japan and China. He is an active member of the PDA, serving on a number of committees, including as chairperson of the Lyophilization Validation Task Force. The PDA awarded Ed the Gordon Personeous award for his long term contributions to the PDA and the James Agalloco award for excellence in education. He is also a member of the American Association of Pharmaceutical Scientists, American Institute of Chemical Engineering, and International Society of Pharmaceutical Engineering.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Explain fundamental concepts of the freeze-drying process
    2. Demonstrate the basics involved in manufacturing freeze-dried products
    3. Explain the complexities of freeze-drying, and the interrelationships of product formulation
    4. Identify the requirements for lyophilization equipment
    5. Identify recent developments in technology
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are involved in sterile drug lyophilization processes or want to gain a basic understanding of lyophilization processes.

    Departments
    Manufacturing, Technical Operations, Quality Assurance, Engineering, Validation

    Roles
    Supervisor, Manager, Technician, Engineer, Scientist, Specialist, Analyst

  • 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: 157 / 0116-0000-18-001-L04-P / 1.2
    Type of Activity: Knowledge

    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 12 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 12 PDH credits.

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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 Washington/Bethesda area is serviced by the following airports: 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 do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

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.

Directions

Registration Fees

Early Registration
Registration Type Price By March 22, 2019
Member $1,889
Non-member $2,267
Gov't/Health Auth./Academic* $1,259










Regular Registration
Registration Type Price After March 22, 2019
Member $2,099
Non-member $2,519
Gov't/Health Auth./Academic* $1,259










* 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 06, 2019, no fee will be charged. After Apr 06, 2019, 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 06, 2019, a full refund will be given minus a $200 fee. After Apr 06, 2019, 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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Tel: +1 (301) 656-5900 ext. 115
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