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Parenteral Drug Association Connecting People, Science and Regulation ®

Container Closure Systems and Integrity Testing - NEW

Apr 06 - Apr 07, 2017 |
Apr 07, 2017 |
Anaheim Marriott | Anaheim, CA
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

This PDA course utilizes lectures, instrument demonstrations, hands-on testing exercises, case studies, and interactive group discussions to provide insight into the fast evolving regulatory landscape in the container closure integrity field and the latest development in testing technologies. The course introduces a practical and meaningful methodology to construct package integrity profiles using a risk-based approach and appropriate Container Closure Integrity (CCI) testing methods.

The key topics include:

  • Up-to-date regulatory and pharmacopeia requirements on CCI
  • CCI requirements for various container and drug product types using a risk-based approach
  • Principles of various CCI testing techniques and their practical applications
  • Testing method selection for both laboratory and in-process testing to formulate comprehensive package integrity verification profiles
  • CCI testing method development, validation approach and best practices
  • Common issues and pitfalls in CCI testing applications

The course provides on-site instrument demonstrations and hand-on testing experience of various advanced CCI testing techniques, including vacuum decay, electrical conductivity and capacitance, laser-based gas headspace analysis, and mass extraction leak test. In addition, participants can take advantage of the breakout sessions to discuss topics of interest with testing experts from major instrument vendors, such as PTI, ATC, and Lighhouse.

Who Should Attend

Parenteral drug packaging engineers and formulation scientists; Laboratory scientific staff and managers; Parenteral manufacturing Staff; Sterility Quality Assurance; Regulatory affair scientists; CMC Project Management; Pharmaceutical packaging component manufacturing staff

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

  • Define current regulatory requirements for container closure integrity verification throughout product life cycle
  • Develop meaningful design requirements for maximum allowed leakage limit for various product-package types
  • Describe working principles of various CCI testing techniques, with focus on deterministic methods, such as vacuum decay, electrical conductivity and capacitance (HVLD), laser-based gas headspace analysis, and mass extraction leak test
  • Develop familiarity with advanced CCI testing technologies via hands-on exercises of testing representative samples
  • Illustrate testing instrument design, calibration, and qualification during instrument demonstration by industry experts
  • Identify advantages and limitations of each CCI technical technique
  • Select appropriate CCI testing methods for specific product-package systems
  • Master CCI testing method development and validation approach
  • Avoid common issues and pitfalls in CCI testing
  • Formulate a comprehensive CCI testing plan throughout product life cycle in support of package integrity verification profile
  • Apply risk-based approaches to develop a CCI control strategy in which various CCI testing methods are used to inform, verify, and demonstrate package integrity

Standard

Member

On or before February 20, 2017
$1,709

After February 20, 2017
$1,899

Nonmember

On or before February 20, 2017
$2,051

After February 20, 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 March 7, 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 lab 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:

Anaheim Marriott
700 West Convention Way
Anaheim, CA 92802
Phone: +1 (714) 622-3056

Contact

For more information, please contact:

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

Lei Li, PhD, Associate Engineer Advisor, Delivery and Device R&D, Eli Lilly and Company

Lei Li currently serves as an engineer advisor at Delivery and Device R&D, Eli Lilly and Company. Dr. Li has 9 years of experience in pharmaceutical and medical device industry, with focus on developing API and drug product packaging in support of clinical development and product commercialization, and establishing cold-chain distribution for biologic products. His current responsibilities include developing package integrity verification profiles for Lilly’s diverse clinical development pipeline portfolio, developing and validating CCI testing methods, and supporting commercial CCI control strategy development for CCI verification throughout drug product life cycle. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Dr. Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.

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 #109 | ACPE #0116-0000-16-040-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=3496

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