Assessing Packaging and Processing Extractables and Leachables Training Course
Registration Options
Individual Registration
Group Registration
This training course will provide answers to two important questions regarding extractables/leachables (E/L): “What are the current and anticipated regulations?” and “How can I perform a scientific- and risk-based assessment to meet expectations for a wide range of pharmaceutical products and delivery system.
Participants will review best practices and current trends related to designing studies and justifications for measurement of E/L from packaging and manufacturing components. The sources of extractables from materials such as plastic, glass and rubber and occurrence of leachables will be discussed. Participants will also learn how to acquire and assess E/L data to enable qualification of materials, components and systems for use throughout the lifecycle of a pharmaceutical product.
Upon completion of this training course, the attendee will be able to:
- Discuss the evolving E/L expectations from a global perspective (US, EU, Japan, and China)
- Recognize the importance for the alignment of Leachable Safety Thresholds and Extractables Best Practices for drug products, delivery devices, and processing/manufacturing components and drug-device combination products
- Identify sources of potential leachables and impact to product quality and safety by understanding the materials being used in various applications
- Apply risk-based approaches to justify strategies for acquiring and assessing E/L
- Identify what specific E/L information must be present in the CMC sections of applications for the various types of drug products (injectables, oral, etc.)
For more options and/or related training courses, please visit the following page(s):
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Standard Registration
Member Price
$999GovernmentMember Only
$699
Health AuthorityMember Only
$699
AcademicMember Only
$699
Non-Member
$1,199
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
Featured Trainers
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Douglas Kiehl
Eli Lilly and Company
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Douglas Kiehl
Eli Lilly and Company
Douglas Kiehl is a Research Advisor at Eli Lilly and Company and leads the Characterization Mass Spectrometry, Extractables/Leachables and Elemental Impurities team. He is responsible for Lilly’s global E&L strategy supporting development and qualification of container/closure and manufacturing systems and drug delivery devices. His team’s responsibilities include performing structural characterization of process impurities, related substances, degradation products and contaminants across development and commercialization phases for the small and large molecule portfolios. Mr. Kiehl has over 36 years' experience with application of advanced mass spectrometry in characterization of diverse chemical entities, 24 years of which are in the Pharmaceutical Industry. He is a member of the USP Packaging and Distribution Expert Committee, the USP Expert Panel on Biocompatibility of Materials Used in Packaging Systems, Medical Devices and Implants, the USP Expert Panel on Elastomeric Closure for Injections, the ELSIE (Extractables/Leachables Safety Information Exchange) Board of Directors, the SPIE Defense and Commercial Sensing Committee and AAPS Impurities Steering Committee. His research interests include the development of advanced mass spectrometry based mapping and visualization techniques to enable the rapid and comprehensive characterization of highly complex mixtures of structurally diverse chemical entities.
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Diane M. Paskiet, MS
West Pharmaceutical Services, Inc.
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Diane M. Paskiet, MS
West Pharmaceutical Services, Inc.
Diane Paskiet has over 30 years of experience in the pharmaceutical industry. She is currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of pharmaceutical packaging and combination products. Previous to this role she was in charge of site operations for West-Monarch Analytical Laboratories. She is on the Product Quality Research Institute (PQRI) Steering Committee and Chair of the Extractables and Leachables Parenteral Drug Product Working Group. Diane is also on the faculty of the Parenteral Drug Association Training Institute. She has author/co-author a number of papers and book chapters related to pharmaceutical packaging, delivery systems and combination products.
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Cheryl M Stults
C & M Technical Consulting, LLC
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Cheryl M Stults
C & M Technical Consulting, LLC
Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of combination products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification, and control. Some prior positions: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She led industry initiatives focused on pharmaceutical packaging and device materials and is a Science Advisor to IPAC-RS and ELSIE. Dr. Stults has been actively involved with the USP Packaging and Distribution Expert Committee contributing to development and revision of materials-related chapters. She holds a Ph.D. in Analytical Chemistry and completed post-doctoral studies in Biochemistry.
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Phoenix Convention Center - South Building
33 S 3rd StreetPhoenix, AZ 85004, USA
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Additional Hotel Information
Renaissance Phoenix Downtown (HQ)
- Rate: $289 + taxes/fees
- Cut-Off Date: Friday, 20 September 2024
- Room Block Opens: Monday, 10 June 2024
Westin Downtown Phoenix
- Rate: $289 + taxes/fees
- Cut-Off Date: Friday, 20 September 2024
- Room Block Opens: Monday, 10 June 2024
Residence Inn Phoenix Downtown
- Rate: $279 + taxes/fees
- Cut-Off Date: Friday, 20 September 2024
- Room Block Opens: Monday, 10 June 2024
Courtyard Phoenix Downtown
- Rate: $269 + taxes/fees
- Cut-Off Date: Friday, 20 September 2024
- Room Block Opens: Monday, 10 June 2024
Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night's room deposit. Individuals will be responsible for payment of their own cancellation fees.