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Parenteral Drug Association Connecting People, Science and Regulation ®

Assessing Packaging and Processing Extractables/Leachables

Aug 09 - Aug 10, 2017 |
Aug 10, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration:  2 days
Time: 8:30 a.m. - 4:00 p.m.

This course will provide answers to two important questions regarding extractables/leachables: “What are the current and anticipated regulations?” and “How can I perform a scientific-based assessment and meet regulatory expectations?”

Participants will review regulations regarding the reporting, identification, and measurement of extractables/leachables (E/L) from packaging materials and product contact items used in drug processing. A detailed discussion on the sources of extractables from materials such as plastic, glass and rubber will be included. E/L from packaging and processing components/materials will also be discussed. Attendees will be shown how to design and execute an E/L study. This course will provide the attendee with a synopsis of the current and anticipated regulations and provide a means to deal with E/L issues in a responsible, scientific, and cost-effective manner.

Who Should Attend

The course will be of significant value to personnel involved in packaging science, drug manufacturing, toxicology, drug formulation, material and component suppliers, CMC and DMF writing, regulatory affairs, analytical chemistry and material science.

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

  • Explain the extractables/leachables expectations in the FDA guidance, USP, ICH, ISO, CFR and other regulatory documents
  • Identify what specific extractables/leachables information must be present in the CMC sections of applications for the various types of drug products (injectables, oral, etc.)
  • Identify sources of extractables from packaging, including combination products and processing components/materials, such as plastics, glass and rubbers
  • Design and execute an extractables/leachables study

Standard

Member

On or before June 26, 2017
$1,709

After June 26, 2017
$1,899

Nonmember

On or before June 26, 2017
$2,051

After June 26, 2017
$2,279


Government/Health Authority/Academic

Member

$1,139

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by July 10, 2017, 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.

Class Schedule

All 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 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 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

This course will take place at:

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

Contact

For more information, please contact:

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

Diane Paskiet, Senior Director of Scientific Affairs, West Pharmaceutical Services

Erica J. Tullo, Technology Manager, E&L - Analytical Labs, West Pharmaceutical Services

ACPEPDA 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 #190 | ACPE #0116-0000-14-063-L04-P | 1.2 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 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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