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Parenteral Drug Association Connecting People, Science and Regulation ®

Temperature Sensitive Packaging and Distribution for Biopharmaceuticals - New Course

Apr 04 - Apr 05, 2018 |
Apr 05, 2018 |
Cold Chain Technologies | Franklin, MA
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Temperature sensitive therapies continue to experience explosive growth while the regulatory landscape is constantly evolving. While packaging and logistics offerings have improved, along with choice of packaging/freight options and new technologies and services that deal with temperature sensitive products, the proper selection and qualification of thermal packaging continues to be elusive.

This course will provide details on regulations and guidance, simplify concepts of thermal science employed by packaging designers, detail proper qualification/validation processes, provide useful evaluation tools, and give attendees hands-on experience with all the materials and equipment used.

Participants successfully completing the course will be able to demonstrate proficiency in the following key areas:

  • Regulations, guidance, and best practices
  • Qualification, thermal science, and packaging design variables
  • Implementation of process validation, a Master Operating Plan, and SOP development
  • Evaluation and implementation of an appropriate temperature monitoring strategy
  • Evaluation of packaging and freight options within a holistic total cost/dose distributed evaluation framework

Who Should Attend

  • Manufacturing: Managers, Supervisors, Operators, Technicians
  • Quality Assurance: Managers, Supervisors, Specialists, Engineers
  • Quality Control: Managers, Supervisors, Analysts
  • Validation: Managers, Specialists
  • Process Development: Specialists, Scientists

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

  • Explain applicable regulations and industry guidance related to the distribution of temperature sensitive therapies
  • Describe variables involved in designing a system and evaluate merits of various solutions and material choices
  • Implement process validation, a master operating plan, and associated SOPs related to temperature sensitive packaging and shipping
  • Develop a shipping system proposal for a given set of requirements
  • Utilize evaluation tools for various situations
  • Design a temperature monitoring program specific to each organization’s unique needs



On or Before February 19, 2018

After February 19, 2018


On or Before February 19, 2018

After February 19, 2018

Government/Health Authority/Academic


All rates in US Dollars. REFUND FOR COURSES: If your written request is received by March 5, 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

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.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided between 12:00 - 1:00 p.m. Snacks will be provided during breaks throughout the day.


The course will be held at:

Cold Chain Technologies
135 Constitution Blvd.
Franklin, MA 02038 USA


For more information, please contact:

David Talmage
Sr. Director, Education
Tel: +1 (301) 656-5900 x137

TJ Rizzo
Sr. Vice President, Global Commercial Operations
Cold Chain Technologies, Inc.
Tel: +1 (774) 233-7233

Jamie Chasteen , Senior Product Manager, Cold Chain Technologies, Inc.

TJ Rizzo, Sr. Vice President, Global Commercial Operations, Cold Chain Technologies, Inc.

Geoff Kaiser, Dir. Engineering & Technical Services, Cold Chain Technologies, Inc.

Jim Nilsen, Dir Business Development, Cold Chain Technologies, Inc.

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 #516 | ACPE #0116-0000-17-010-L04-P | 1.2 CEUs
Type of Activity: Application

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.