Validation of Lyophilization

Location: PDA Training and Research Institute in Bethesda, Maryland
Date: December 3 - 4, 2014
Time: 8:30 a.m. – 4:00 p.m.
Duration: 2 Days

This course is designed to give participants an understanding of the requirements for qualification of a lyophilizer and validation of lyophilization processes.  In addition, the participant can gain an understanding of the basic principles of lyophilization and the techniques utilized in evaluation of lyophilized materials.  The format of the course will be lecture and discussion of principles and case studies / examples.  Participants are encouraged to come prepared with questions and real-life issues.

Who Should Attend

Personnel from all levels involved in manufacturing, validation, and quality aspects of the lyophilization process will benefit from this course.  This includes personnel from commercial manufacturing operations as well as R&D/clinical manufacturing.

Prerequisites

Experience in development, analytical, manufacturing, or quality activities relating to lyophilization is preferred, but not essential.  Knowledge of cGMP and regulatory guidances concerning validation is desirable.  Familiarity with statistical tools is helpful, but not required.

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

  • Identify the critical process parameters involved in lyophilization
  • Describe the basic design of lyophilizers
  • Define the essential requirements for qualification of a lyophilizer and understand the impact of those tests on process design
  • Explain the impact and limitations of analytical methods used to evaluate lyophilized materials
  • Define the requirements for process validation for lyophilized materials
Karen A. Bossert, PhD, RPh, Vice President, Scientific Affairs, Lyophilization Technology, Inc.

Barbara Berglund, Manager, QA, Amresco, LLC

To receive a discount when registering for both courses, please download and complete the registration form and fax it to +1 (301) 986-1093. If you have any questions please contact Patresa Day at + 1 (301) 656-5900 ext. 115.

Price On or Before October 17, 2014
Price After October 17, 2014
Standard
Government / Health
Authority / Academic
Standard
Government / Health
Authority / Academic
Member Non-Member Member Non-Member Member Non-Member Member Non-Member
Fundamentals of Lyophilization (December 1 - 2) $1,525 $1,795 $950 $1,050 $1,695 $1,995 $950 $1,050
Validation of Lyophilization (December 3 - 4) $1,525 $1,795 $950 $1,050 $1,695 $1,995 $950 $1,050
Both Courses $2,745 $3,230 $1,900 $2,100 $3,050 $3,590 $1,900 $2,100

All rates in US dollars.

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 register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 7:30 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 the PDA Training and Research Institute:

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

Contact

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 ext. 151
Email: ko@pda.org
For registration inquiries please call: +1 (301) 656-5900 ext. 115
The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms.

PDA #282 | ACPE #0116-0000-11-282-L04-P | 1.2 CEUs
Type of Activity: Knowledge, Application

From: 
Email:  
To: 
Email:  
Subject: 
Message: