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2018 PDA Container Closure Performance and Integrity Conference

Assuring Packaging Quality in Delivery Systems
Jun 13 - Jun 14, 2018 |
Jun 14, 2018 |
Hyatt Regency Bethesda | Bethesda, MD
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  • Western Hemisphere Events
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Speaker Biographies

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: schneider@pda.org

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115
Email: registration@pda.org

Exhibition Inquiries
David Hall
Vice President, Sales 
Tel: +1 (240) 688- 4405
Email: hall@pda.org

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


Conference Registration | June 13-14, 2018

Member

By April 3, 2018
$1,895

After April 3, 2018
$2,295

Non-member

By April 3, 2018
$2,174

After April 3, 2018
$2,574


Young Professional Member †

Member

By April 3, 2018
$948

After April 3, 2018
$1,148

† You must be a member to take advantage of this rate.


Government/Health Authority

Member*

$700

Non-member*

$800

*For this member type or discounted rate, online registration is not available and must be faxed in.


Academic

Member

$700

Non-member*

$800

*For this member type or discounted rate, online registration is not available and must be faxed in.


Student

Member

$280

Non-member*

$310

*For this member type or discounted rate, online registration is not available and must be faxed in.


Wednesday/Thursday Only

Member

$1,348

Non-member

$1,487

All prices in US dollars.

*For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to take advantage of this rate.

Please note: In order to receive the prevailing registration rate, your registration(s) must be received by PDA by 5:00 p.m. ET on or before the date noted.

Please read PDA's confirmation, substitution, refund, and photo release policies for this workshop and course.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

Please let us know if you have any special dietary requirement we may assist you with. Please contact us at registration@pda.org for help.

CONFIRMATION: A letter of confirmation will be sent to you once payment is received. You must have this written confirmation to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. If you have submitted a purchase order or requested an invoice please be advised that a credit card guarantee is needed. Please be advised that if your payment or written cancelation notice is not received by April 13, 2018 your credit card will be charged the prevailing rate.

SUBSTITUTIONS: If you are unable to attend, substitutions can be made at any time, including onsite for a fee of $200. If you are a non-member substituting for a member, you will be required to pay the difference non-member fee. If you are pre-registering as a substitute attendee, indicate this on the registration form.

REFUNDS: Refund requests must be in writing and faxed to +1 (301) 986-1093. (Emails and phone messages are not accepted). Refunds for Full Conference, Workshops and Events: If your written request in received on or before April 13, 2018, you will receive a full refund minus a $200 processing fee. After that time, no refunds or credit requests will be approved. Onsite registrants are not guaranteed to receive Conference materials until all advanced registered attendees receive them. PDA reserves the right to modify the material or speakers/instructors without notice or to cancel an event. If an event must be canceled, registrants will be notified by PDA in writing as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancelation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

PLEASE NOTE: Photo ID will be required in order to pick up badge materials on-site. This important security procedure will prevent anyone other than the registrant from picking up their badge and materials.

RECORDING/PHOTO RELEASE: By registering for these events, I authorize PDA to record and photograph me and to use the recordings/photographs in all formats and media for any purpose, including for education, marketing, and trade purposes. I hereby release PDA from all claims arising out of the use of the recordings/photographs, including without limitation all claims for compensation, libel, invasion of privacy, or violation of copyright ownership. Tape recordings are prohibited at all PDA events.

Hyatt Regency Bethesda

Hyatt Regency Bethesda
One Bethesda Metro Center
7400 Wisconsin Avenue
Bethesda, MD 20814 USA
Tel: +1 (301) 657-1234

Website: https://bethesda.regency.hyatt.com

The cut-off date has past, however rooms are still available at the prevailing rate based on availability.

Hotel Accommodations

A block of rooms have been reserved for meeting participants at the Hyatt Regency Bethesda. The rate is $249 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, May 14, 2018. After this date, reservations can be made on a space-and rate-available basis only. Check-in time is 4:00 p.m.; check-out time is 12:00 p.m.

To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Bethesda at +1 (301) 657-1234. Please make sure to tell the reservationist that you are with the PDA group attending the 2018 PDA Container Closure Conference to receive the PDA group rate.

Individual Cancellation

Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 24 hours prior to the date of arrival by 3 p.m. to avoid cancellation fees.

Amenities

Just one mile from the MD/DC line, Hyatt Regency Bethesda is perfectly-positioned to allow you to take advantage of all Washington, DC has to offer. Located directly above the Bethesda Metro station (Red Line), you're walking distance to numerous area businesses and minutes from Maryland's best shopping, dining and cultural attractions. Take advantage of the hotel's Smart Phone Check-in and the 24 hour StayFit™ fitness center during your stay. The Hyatt Regency offers complimentary Wi-Fi in all guestrooms and public areas.

Area Airports

Reagan National- (DCA) is located 12.7 miles from the hotel and all major carriers service this airport

Dulles International Ariport- (IAD) is 25 miles away, all major carriers service this airport

Baltimore Washington- (BWI) is 35.2 miles away, all major carries service this airport

Ground Transportation

Preferred Vendor

Taxi fares from Reagan National (DCA) are approximately $45-55.00 one way, not including tip, and will take about 30 minutes. One way taxi fares from Dulles (IAD) is approximately $75 and from Baltimore/Washington (BWI) is about $95.

Driving Directions

Hyatt Regency Bethesda hotel is located on One Bethesda Metro Center.

Hotel Parking

Self-parking at the Hyatt Regency Bethesda is $12 daily/overnight. Valet parking is $18 daily or $30 overnight.

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Container Closure Performance and Integrity Conference offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. This workshop will bring together industry experts from Biotech, Clinical Trial Materials, Combination Products, Flexible Container, Packaging Science, Quality Risk Management , Sterile Processing, Medical Device, Drug Delivery, Compliance, Engineering, Manufacturing, Quality, and Regulatory Affairs .

At this conference you will be exposed to high quality attendees from a variety of manufacturing companies – making this a must attend meeting. In addition, high profile sponsorships are available for lanyards, notepads, audience response systems, tote bags, pens, refreshment breaks, lunch and networking reception. We’ll create a customized sponsorship to fit your needs and budget.

For more information about exhibit and sponsorship opportunities, please contact:

David Hall, Vice President, Sales

Tel: +1 (301) 760-7373
Cell: +1 (240) 688-4405
Fax: +1 (301) 986-0296
Email: hall@pda.org

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4119

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