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2018 PDA Container Closure Performance and Integrity Conference

Jun 13 - Jun 14, 2018
Bethesda, MD

Assuring Packaging Quality in Delivery Systems

  • Conference
  • The Americas

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Program Highlights

At the 2018 PDA Container Closure Performance and Integrity Conference, exchange ideas with industry peers and regulatory experts regarding how to meet the packaging demands for new medicines, novel delivery devices, and evolving regulations.

Don't miss this opportunity to take a patient-centered look at improving container closure performance and integrity throughout the product lifecycle!

Overview

Currently, the pharmaceutical/biotech industries are experiencing a dynamic evolution that will redefine how patients are treated. Thanks to recent development of drug/biologic products in fully integrated delivery systems, patients can now receive life-saving medications in the comfort of their homes. The rapid evolution in drug delivery systems has provided drivers for novel container closure designs and imposed new technical challenges. No longer can container closure systems be viewed as an isolated sub-assembly; they are an integral part of a product system and should be a consideration early in the drug development process.

Container closure performance and integrity are critical for providing robust protection to sensitive drug formulations against a large variety of physicochemical stresses (e.g., light, temperature, chemical, microbial contamination, vibration, and shock). The system must work together to ensure accurate dosing and delivery to the patient. These attributes must be maintained throughout the product lifecycle, ranging from the manufacturing, storage, and distribution, to use and disposal by end users.

The 2018 PDA Container Closure Performance and Integrity Conference will address the complexities and challenges to container closure performance and integrity. The Conference stems from the fundamental concept for a systems mindset with the patient in mind. The system-level complexities and interdependencies cannot be effectively addressed by simply extending the traditional container-focused development-qualification framework. Integrated drug delivery systems and container closure systems are subject to complex intrinsic interactions with the drug formulation and the device components.

The goal of the Conference is to provide a forum where attendees can broaden their understanding of holistic requirements related to performance and protection by identifying potential failure modes throughout the life of a product, and de-risking container closure design during development. Talks will cover a wide range of topics, including best practices for container closure design, container closure integrity testing, system engineering approaches for performance optimization, critical secondary/tertiary packaging and cold chain development, and regulatory requirements in the combination product platform space.

Learning Objectives

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

  • Describe the complex and intrinsic interactions among container closure, drug product formulation, and delivery system in combination products
  • Delineate protection and performance risks and potential failure modes throughout product lifecycle
  • Explain the FDA interpretation of protection and performance requirements to ensure patient safety and efficacy
  • Summarize the rationale for required testing of combination products, container closure systems, and/or delivery devices
  • Discuss the importance of ongoing industry initiatives, such as PQRI, PDA, and others
  • Recognize system engineering-based approaches to identify and fulfill design requirements for container closure systems 
  • Identify available resources for combination product and container closure testing

Who Should Attend

Biotech | Clinical Trial Materials | Combination Products | Flexible Container | Packaging Science | Quality Risk | Management | Sterile Processing | Medical Device | Drug Delivery

Departments: Biochemistry | Biology | Chemistry | Compliance | Engineering | Manufacturing | Development | Quality | Regulatory Affairs | Research

Contact

Brooke Schneider, CMP
Manager, Programs
Tel: (301) 656-5900 ext. 111
Email: [email protected]

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: [email protected]

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: [email protected]

Agenda

  • Wednesday, June 13

    7:00 a.m. – 5:30 p.m.
    Registration Open

    7:00 a.m. – 8:30 a.m.
    Continental Breakfast

    8:15 a.m. – 8:30 a.m.
    Welcome and Opening Remarks from Conference Co-Chair 
    Diane Paskiet,
    Director, Scientific Affairs, West Pharmaceutical Services

    8:30 a.m. – 10:00 a.m.
    P1: Assuring Packaging Quality Across the Product Lifecycle
    Moderator:
    Diane Paskiet, Director, Scientific Affairs, West Pharmaceutical Services

    Session Description: A holistic strategy for drug product quality includes building in packaging and delivery system performance properties from early development through commercialization. Integration of the drug product together with the delivery device is critical to the patient experience and ensuring successful treatments. There is a wide diversity of packaging and device delivery constituents which introduce unique risk factors for performance and integrity based upon intended use. Critical attributes for packaging and delivery system quality must be established and tested to meet the requirements of the drug product throughout its lifecycle. This session will provide an overview of regulatory expectations for evaluation of different types of device constituents, and considerations for defining quality elements for lifecycle management.

    8:30 a.m. – 9:00 a.m.
    Regulatory Expectations for Packaging Quality Across the Product Lifecycle: An Industry Perspective
    Suzette M. Roan, JD, Senior Director, Regulatory Affairs – Devices and Combination Products, Sanofi

    9:00 a.m. – 9:30 a.m.
    Technical Considerations for Design and Quality Evaluation of Drug Delivery Devices
    CAPT Alan M. Stevens, Branch Chief, General Hospital Devices Branch, CDRH, FDA

    9:30 a.m. – 10:00 a.m.
    Question and Answers/Discussion

    9:45 a.m. – 6:30 p.m. 
    Exhibit Area Open

    10:00 a.m. – 10:45 a.m.
    Refreshment Break and Poster Presentations in Exhibit Area

    10:45 a.m. – 12:15 p.m.
    P2: Implementing Qualification and Development Strategies for Inherent Package
    Moderator: Roger Asselta,
    Vice President, Technical Services, Genesis Packaging Technologies, A Division of R-V Industries, Inc.

    Session Description: This session will explore examples of methodologies for assessing inherent package integrity, developing, and qualifying container closure systems.

    10:45 a.m. – 11:15 a.m.
    A Case Study in the Characterization of a Container Closure to Support Sterile Product Development
    Gary J. Mills, Associate Director, Drug Product Development, TESARO

    11:15 a.m. – 11:45 a.m.
    A Holistic Strategy for Optimizing an Integral Parenteral Package to Ensure Container Closure Integrity
    Dominick DeGrazio, Senior Associate Scientist, Drug Product Development - Large Molecules, Janssen R&D, LLC

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/Discussion

    12:15 p.m. – 1:45 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA registration desk.

    1:45 p.m. – 3:15 p.m.
    P3: Integrating Quality and Regulatory Requirements in Combination Product Development
    Moderator: Olivia Henderson,
    Principal Engineer, Container Science and Engineering, Amgen Inc.

    Session Description: Combination products integrate many elements of drug product development but have some different elements as well. This session will explore the different requirements and approaches to developing an integrated drug delivery device.

    1:45 p.m. – 2:15 p.m.
    Build an Integrated Quality and Technical Framework to Enable Combination Product Development
    Jon Bell, Managing Partner/Principal, Fulcrum PDC

    2:15 p.m. – 2:45 p.m.
    Regulatory Considerations for Drug Transfer Devices
    Sarah Mollo, Microbiologist, CDRH, FDA

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/Discussion

    3:15 p.m. – 4:00 p.m.
    Refreshment Break and Poster Presentations in Exhibit Area

    4:00 p.m. – 5:30 p.m.
    P4: Designing Container Closure Systems for Enhanced Functionality and Usability
    Moderator:
    M. Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, CDRH, FDA

    Session Description: The design of a CCS goes beyond ensuring compatibility with the drug or biologic product it will contain. It includes considerations for usability of the product by patients or clinicians, and functionality assessments to ensure that drug integrity is preserved, all parts of the CCS are compatible, and all potential risks derived from the use of different components together.

    4:00 p.m. – 4:20p.m.
    The Interface between Container Closure, Usability, and Functional Performance
    Steven W. Badelt, PhD, Founder and Managing Partner, Suttons Creek, Inc.

    4:20 p.m. – 4:40 p.m.
    Microbiological Quality of Drug Products after Penetration of the Container System for Dose Preparation
    John W. Metcalfe, PhD, Quality Assessment Lead, Division of Microbiology Assessment, Office of Process and Facilities/Office of Pharmaceutical Quality, CDER, FDA

    4:40 p.m. – 5:00 p.m.
    Regulatory Considerations for Complex Container Closure System
    Carolyn Dorgan, BBME, MS,
    Biomedical Engineer, CDRH, FDA

    5:00 p.m. – 5:30 p.m.
    Questions and Answers/Discussion

    5:30 p.m. – 6:30 p.m.
    Networking Reception in Exhibit Area

    Thursday, June 14

    7:15 a.m. – 5:45 p.m.
    Registration Open

    7:15 a.m. – 8:15 a.m.
    Continental Breakfast

    7:15 a.m. – 8:15 a.m.
    Breakfast Session: Requirements and Guidelines for Performance and Integrity Testing
    Moderator: Lei Li, PhD,
    Engineering Advisor, Eli Lilly and Company

    Session Description: Requirements for functionality testing in USP has been limited to testing closures intended to be pierced by a hypodermic needle for penetrability, fragmentation, and self-sealing capacity. There is now greater diversity of elastomeric components and applications, which introduces additional risk factors to consider when qualifying a component for its intended use. Appropriate performance and functionality testing is necessary for a wider range of systems needed by the end-user compared to current state of testing to a specification that may not represent actual use. This session will take a look at the proposed USP <382> chapter and application to a various container closure systems. In addition, the PDA Technical Report 27 Pharmaceutical Package Integrity, originally published in 1998, is being revised to include practical guidance on applying risk-based approach for CCI evaluation and verification throughout product lifecycle. The content will be updated to address challenges in CCI testing of novel package designs, test method selection considerations, and the emerging CCIT technologies. The session will provide an overview of the revision and highlight key current topics.  

    7:15 a.m. – 7:35 a.m.
    Functionality Testing for Elastomeric Closures USP Present and Future
    Daniel L. Bantz, Technology Manager, Product Performance and Packaging, West Pharmaceutical Services

    7:35 a.m. – 7:55 a.m.
    A New PDA Technical Report on Package Integrity Testing: Challenges, Risk, and New Technology
    Donald C. Singer, Manager, Microbiology, Biopharmaceutical GMP Operations, GlaxoSmithKline

    7:55 a.m. – 8:15 a.m.
    Question/Answer and Discussion

     

    8:30 a.m. – 10:00 a.m.
    P5: Container Closure Integrity Assurance throughout Manufacturing Processes
    Moderator: Marc Hogreve,
    Senior Engineer Integrity Testing Solutions, Sartorius Stedim Biotech GmbH

    Session Description: Sterile drug products require the establishment of CCI of the final container. However, the maintenance of critical quality attributes, including sterility of the drug product may rely upon steps further upstream in the drug manufacturing process. CCI of specific parts of the production process may be required to maintain the drug product critical quality attributes. The use of single-use systems in these critical process steps has raised an increased regulatory scrutiny in terms of integrity assurance of various types of single-use bulk containers for liquid and frozen storage and shipping, processing, transfer, and formulation and filling. Establishing CCI of these systems in use at critical stages of the process begins with development and validation for each individual process system used in the process, and may include tests to verify CCI during the single use system lifecycle. This session focuses on assurance of CCI along the drug product manufacturing lifecycle, including principles like QRM, QbD, quality and process control, as well as integrity testing practices.

    8:30 a.m. – 9:00 a.m.
    Proven Integrity: Robustness, Science, and Technologies for Proven Single-Use Container Closure Integrity
    Carole Langlois, Sr. Product Manager Fluid Management Technologies, Sartorius Stedim Biotech

    9:00 a.m. – 9:30 a.m.
    Microbial Challenge Testing in an Aerosol System
    Alexandre Mura, Site Head, Confarma SAS

    9:30 a.m. – 10:00 a.m.
    Questions and Answers/ Discussion

    9:45 a.m. – 4:00 p.m.
    Exhibit Area Open

    10:00 a.m. – 10:45 a.m.
    Refreshment Break and Poster Presentations in Exhibit Area

    10:45 a.m. – 12:15 p.m.
    P6: Protecting the Drug Product through the Product Lifecycle: Shipping Considerations
    Moderator:
    Paul Harber, Principal, Modality Solutions

    Session Description: We will look at two product categories revealing specific supply chain risks and challenges from the point of formulation to the patient bedside. Vaccines and protein solutions can be damaged when exposed to shock events. The mechanics related to this damage can be described by studying the effects of cavitation induced by filling equipment and shock events. Cellular and gene therapy products require an unbroken supply chain that must maintain very low temperatures to ensure therapeutic benefit to the patient. Measures employed in the design of the supply chain to ensure safety and efficacy will be presented.

    10:45 a.m. – 11:15 a.m.
    Protein Aggregation and Particle Formation as a Function of Shock Events
    Corinne S. Lengsfeld, PhD, Vice Provost for Research and Graduate Education, University of Denver

    11:15 a.m. – 11:45 a.m.
    Optimization of Capping Parameters for Maintaining Container Closure Integrity for Ultra-Low Storage Temperature
    Pooja Sane, PhD, Scientist, Formulation Department, BioMarin Pharmaceutical Inc.

    11:45 a.m. – 12:15 p.m.
    Questions and Answers/ Discussion

    12:15 p.m. – 1:45 p.m.
    Lunch on Your Own. Exhibit Area Closed. A listing of local restaurants is available at the PDA registration desk.

    1:45 p.m. – 3:15 p.m.
    P7: USP <1207> and Beyond: Novel Container Closure Integrity Testing Technologies and Applications
    Moderator:
    Dominick DeGrazio, Senior Associate Scientist, Drug Product Development - Large Molecules, Janssen R&D, LLC

    Session Description: The recent USP <1207> update and the ensuing Annex 1 revision have prompted the utilization of highly sensitive and deterministic methodologies to assess container closure integrity throughout the product lifecycle. As no CCIT method is the gold standard, the need to develop novel technologies that improve leak detection, ease-of-use, and sample throughput is becoming increasingly important. Simultaneously, the use of CCIT techniques should be complemented by adequate seal quality testing. Correlating seal quality to CCIT in package development lays the foundation for a control strategy more aptly designed to mitigate CCI risk during manufacturing, release, and stability.

    1:45 p.m. – 2:05 p.m.
    Optical Emission Spectroscopy, an Emerging Technology for Container Closure Integrity Testing
    Philippe Bunod, Product Manager - Integrity Test Solutions, Pfeiffer Vacuum SAS

    2:05 p.m. – 2:25 p.m.
    Mechanistic Understanding of Container Closure Sealing Performance via Modeling and 4D X-Ray Computed Tomography
    Coralie A. Richard, PhD, Associate Senior Consultant Engineer, Eli Lilly and, Company and Qingyu Zeng, PhD, Principal Research Scientist, West Pharmaceutical Services, Inc.

    2:25 p.m. – 2:45 p.m.
    Container Closure Integrity: Specific Strategies for Unique Applications
    Oliver P. Stauffer, CEO, Packaging Technologies and Inspection

    2:45 p.m. – 3:15 p.m.
    Questions and Answers/ Discussion

    3:15 p.m. – 4:00 p.m.
    Refreshment Break and Poster Presentations in Exhibit Area

    4:00 p.m. – 5:30 p.m.
    P7: Drug Product Intrinsic Interactions with Delivery Systems
    Moderator:
    Lei Li, PhD, Engineering Advisor, Eli Lilly and Company

    Session Description: Drug product defines the protection requirements of its container closure system. Many new biological products, such as cellular and gene therapy products, require container closure systems maintain integrity at extremely low temperature storage conditions. Further, drug product interactions with critical components of the primary packaging system could adversely affecting integrity and performances of the container closure and drug delivery system. On the other hand, the packaging processes and delivery system design can affect how a drug product is manufactured, administrated to, and subsequently perceived (e.g. pain) and absorbed by patient. Additional stresses may be applied to drug product during manufacturing, packaging, and dose administration; the packaging components may adulterate drug product during storage. In order to ensure patients receive high quality product at the right dose, these intrinsic interactions must be identified, characterized, and their potential impact should be taken into consideration during system design and process development. 

    4:00 p.m. – 4:30 p.m.
    Considerations for Container Closure Integrity Method Selection and Development - Impact of the Product, Package, and Study Goals
    Brandon Zurawlow, Associate Director, Container Qualification & CCIT, Whitehouse Labs, a Division of AMRI

    4:30 p.m. – 5:00 p.m.
    Key Considerations for Assessing Impact of 100% On-Line High Voltage Leak Detection on Drug Product Stability
    Allison L. Dill, PhD, Sr Research Scientist, Eli Lilly and Company

    5:00 p.m. – 5:30 p.m.
    Questions and Answers/ Discussion

    5:30 p.m. – 6:00 p.m
    Closing Remarks from Conference Co-Chair
    Lei Li, PhD, Engineering Advisor, Eli Lilly and Company


Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    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:


    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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