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Parenteral Drug Association Connecting People, Science and Regulation ®

Fundamentals of Lyophilization

May 22 - May 23, 2017 |
May 23, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration:  2 days
Time: 8:30 a.m. - 4:00 p.m.

This course is designed for participants to develop an understanding of the basic principles and practical aspects of lyophilization technology. Selected topics include overview of 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. At course completion, attendees will have a general overview and working knowledge for practical application in development, production, and evaluation of lyophilized parenterals.

Who Should Attend

This course is suitable for engineers, manufacturing and technical support personnel. QA/QC and R&D personnel would also benefit from this course.

Upon completion of this course, you will be able to:

  • Explain fundamental concepts of the freeze drying process
  • Demonstrate the basics involved in manufacturing freeze-dried products
  • Explain the complexities of freeze-drying, and the interrelationships of product formulation
  • Identify the requirements for lyophilization equipment
  • Identify recent developments in technology

Standard

Member

On or before April 7, 2017
$1,709

After April 7, 2017
$1,899

Nonmember

On or before April 7, 2017
$2,051

After April 7, 2017
$2,279


Government/Health Authority/Academic

Member

$1,139

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by April 24, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

Class Schedule

All lecture courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.

Location

The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 USA

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

Edward H. Trappler, President, 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.

Continuing Education for Pharmacists

ACPEPDA 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 #157 | ACPE #0116-0000-14-066-L04-P | 1.2 CEUs
Type of Activity: Knowledge

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 (PDHs) 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 PDHs.

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