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Parenteral Drug Association Connecting People, Science and Regulation ®

Assessing Packaging and Processing Extractables/Leachables

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.

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



On or before August 27, 2018

After August 27, 2018


On or before August 27, 2018

After August 27, 2018

Government/Health Authority/Academic



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 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.


The course will be held at:

Loews Royal Pacific Resort
6300 Hollywood Way
Orlando, Florida 32819


For more information, please contact:

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

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

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

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 #190 | ACPE #0116-0000-17-041-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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