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Parenteral Drug Association Connecting People, Science and Regulation ®

Understanding Product Options, User Needs and Fill-Finish Requirements for Nested Format Syringes, Cartridge Containers and Drug Delivery Systems

Oct 11 - Oct 12, 2018 |
Oct 12, 2018 |
Loews Royal Pacific Resort | Orlando, FL
  • Education
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Duration:  2 days
Time: 8:30 a.m. - 4:00 p.m.

If you are developing a drug intended for prefilled applications, the component design and material selection during development must take into account intended user requirements and fill finish requirements. This course will focus on providing a detailed understanding of the newest packaging technologies that support evolving drug and patient needs, considerations that must take into account, quality expectations to fulfill regulatory requirements, and how new manufacturing strategies are being applied to provide flexibility and decreased investments. The course will follow a practical approach to assist the audience in understanding influences of all involved components and processes such as glass, polymer, elastomer, bulk, nested, silicon, filling and closing. The instructors will give a detailed insight of the complex interaction between components, containers and processes, and will follow with discussions on avoiding issues in development and overcoming hurdles faster.

Who Should Attend

This course is for drug development scientists, packaging and conditioner development engineers and device engineers, as well as personnel who are in manufacturing for fill-finish, QA involved in fill-finish and sterility assurance, product management, technical operations, purchasing and brand marketing.

 

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

  • Recognize all steps involved in a functioning system of drugs, containers, devices and processes
  • Distinguish and resolve potential issues in the interaction and integration of drugs, processes, containers and delivery devices
  • Evaluate the methods of analysis and create the best and quickest way of development
  • Identify and address any challenges during development
  • Identify all steps involved in the development of a primary packaging container and fill-finish technology
  • Describe the processes and influences in minimizing risk and expediting drug launch and market entry
  • Demonstrate the system to customers, partners and colleagues to identify potential challenges
  • Explain the needs of all components and outline processes to colleagues
  • Defend needs and timelines to the organization

Standard

Member

On or before August 27, 2018
$1,743

After August 27, 2018
$1,937

Nonmember

On or before August 27, 2018
$2,092

After August 27, 2018
$2,324


Government/Health Authority/Academic

Member

$1,162

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by September 11, 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 info@pda.org 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.

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

Location

The course will be held at:

Loews Royal Pacific Resort
6300 Hollywood Way
Orlando, Florida 32819

Contact

For more information, please contact:

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

Wenzel Novak, Market Development Director, Optima Machinery

Tibor Hlobik, Sr. Director Product Management Prefilled Systems & Delivery, West Pharmaceutical Services, Inc.

Horst Koller, CEO, HK Packaging Consulting GmbH

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 #546 | ACPE #0116-0000-18-008-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.

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https://store.pda.org/Meetings/Login.aspx?ID=4012

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