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Parenteral Drug Association Connecting People, Science and Regulation ®

Validation of Lyophilization

May 23 - May 25, 2018 |
May 25, 2018 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration:  2.5 days
Time: 8:30 a.m. - 4:00 p.m.

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 will 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.


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



On or before April 6, 2018

After April 6, 2018


On or before April 6, 2018

After April 6, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by April 23, 2018, 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 or +1 (301) 656-5900.

General Course Information

This course begins at 8:30 a.m. and ends at 4:00 p.m., Wednesday, May 23 and Thursday, May 24. The course attendees will be released at 12:00 p.m. on Friday, May 25.

Please arrive at the 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.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


The course will be held at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
Bethesda, MD 20814 USA

Recommended Hotel

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


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151

Karen A. Bossert, PhD, RPh, Vice President, Scientific Affairs, Lyophilization Technology, Inc.

Karen joined Lyophilization Technology, Inc. in 2005 as Vice-President, Scientific Affairs where she is responsible for scientific and technical direction for client projects and providing consulting services. She is responsible for all Quality aspects of clinical manufacturing, and is the primary Regulatory contact for the company. Karen is also a member of the Scientific Advisory Board, directing and overseeing internal research projects for the company.

Karen has over 20 years experience in pharmaceutical manufacturing that includes lyophilization and validation. She received her Bachelor of Science degree in Pharmacy at The Albany College of Pharmacy and her Doctorate in Pharmacy at The Philadelphia College of Pharmacy and Science.

Her experience in the pharmaceutical industry includes formulation and product development, validation, clinical manufacturing and parenteral production. She started her career in 1988 a senior research pharmacist at Sterling-Winthrop Research Institute in Rensselaer, New York. In 1989 she transferred to SmithKline Beecham Pharmaceuticals as Associate Sr. Investigator in Clinical Manufacturing Pharmaceutical Sciences. She held numerous positions at GlaxoSmithKline in the US and the UK, with her last position as Manager, Manufacturing Development for sterile products and bulk APIs. She then joined Regeneron Pharmaceuticals in 2000 as Director, Manufacturing, being responsible for commercial manufacturing. In 2002, she was promoted to Sr. Director, Quality Assurance.

Karen has authored and presented numerous papers and courses in freeze drying. She has been an instructor in the field since 1992 for The Center for Professional Advancement as well as the Institute for International Research, and the Parenteral Drug Association. Karen is an active member of American Association of Pharmaceutical Scientists, American Pharmaceutical Association, International Society for Pharmaceutical Engineers, International Society of Lyophilization-Freeze Drying, and the Parenteral Drug Association (PDA).

Barbara Berglund, PhD, CQM/OE, Director of Health Services

Barb Berglund has been working in the pharmaceutical industry, specifically with sterile parenteral dugs, for over 15 years. Her experience includes her current role as a Quality Partner as well as strategic leadership roles in the laboratory, project management, and clinical trial manufacturing. While in project management and manufacturing, she gained direct hands-on knowledge of development stage, clinical trial, and commercial scale lyophilization of active ingredients and finished pharmaceuticals. She managed QC groups responsible for analytical procedure transfer and validation activities in support of contract manufacturing clients. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007 and her Green Belt certification in 2008.

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 #544 | ACPE #0116-0000-18-002-L04-P | 1.5 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 15 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 15 PDHs.

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