Essential Elements of Extractables and Leachables: From Material Selection to Final Report
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This lecture and discussion based course will demonstrate, through examples and case studies, the essential elements of the E&L process, from the selection and evaluation of packaging materials to the writing of the study report (conversion of data to information). Extractables and leachables from both packaging and processing materials will be discussed with emphasis on small and large volume injectable drug products. The application of important concepts such as the Safety Concern Threshold (SCT), Qualification Threshold (QT), and Analytical Evaluation Threshold (AET) will be demonstrated with SVP/LVP examples. Current best practices, particularly those presented by PQRI, for the toxicological and safety qualification of extractables/leachables will be reviewed. Finally, a review of regulators expectations with regard to common E&L study practices will be shared.
Who Should Attend
Professionals associated with drug and device companies, testing laboratories, consulting enterprises, and packaging/processing materials developers, standards development and regulatory agencies will benefit from this course. This includes those working in the areas of:
- Packaging/Package Engineering
- Drug Formulation
- Analytical Chemistry
- Pharmaceutical Science
- Quality Systems & Control
- Regulatory Affairs
- Materials Development
- Consultants - Packaging & Process
Time: 8:30 a.m. - 4:00 p.m.
Agenda
Discover What's Happening Each Day
Upon completion of this course, you will be able to:
- Evaluate and select packaging components/materials in order to mitigate safety and quality concerns
- Describe and be able to use the SCT, QT, and AET concepts to plan and evaluate data from E&L studies (Data vs. Information)
- Explain the safety and toxicological issues that impact the analytical testing challenges
- Discuss both the published regulatory documents and current regulators expectations regarding E&L practices
Location and Travel
Venue Details and Accommodations
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.
Hyatt Regency Huntington Beach Resort and Spa
21500 Pacific Coast HwyHuntington Beach, CA
Diane Paskiet, Associate Director, Scientific Affairs, West Pharmaceutical Services, Inc.
Registration
Pricing Options
More information coming soon.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Continuing Education for Pharmacists
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 #252 | ACPE #0116-0000-15-020-L04-P | 0.6 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 6 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 6 PDHs.
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