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Temperature Sensitive Packaging and Distribution for Biopharmaceuticals - New Course

Apr 04 - Apr 05, 2018
Franklin, MA

  • Education
Cancelled

Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Overview

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
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Agenda

  • 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

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    More information coming soon.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Cold Chain Technologies

135 Constitution Blvd
Franklin, MA

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.

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Standard

Member

On or Before February 19, 2018
$2,468

After February 19, 2018
$2,753

Nonmember

On or Before February 19, 2018
$2,973

After February 19, 2018
$3,304

Government/Health Authority/Academic

$1,652

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 [email protected] 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.

Location

The course will be held at:

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

Contact

For more information, please contact:

David Talmage
Sr. Director, Education
PDA
Tel: +1 (301) 656-5900 x137
Email: [email protected]

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

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

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 immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
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Tel: +1 (301) 656-5900 ext. 115
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