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Parenteral Drug Association Connecting People, Science and Regulation ®

2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop

Exploring Regulatory Expectations and Patient Considerations for the Future
Oct 02 - Oct 03, 2017 |
Oct 03, 2017 |
Omni Shoreham Hotel | Washington, DC
  • Workshop
  • Western Hemisphere Events
Exhibition: October 2-3
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Co-Sponsored by:

Recent advances in disease treatment have given rise to a new age of medical devices that have forever changed how patients are treated. Patients can receive life-saving medications in the comfort of their homes, where just ten years ago, they may have been hospitalized for extended periods of time. It truly is a very exciting time to be working in the pharmaceutical/biotech industry.

These technological advances have been accompanied by revisions in regulatory requirements. Drug product contact surfaces are no longer limited to glass and elastomeric materials. As a result, the required testing to demonstrate safety and drug product compatibility has increased significantly. No longer can combination products be viewed as a simple compilation of discrete components. They are drug delivery systems, and must be evaluated as such.

The 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop addresses the complexity of assessing compatibility and safety issues for combination products from an industrial and regulatory perspective. Our goal is to present a forum where attendees can learn about the multi-faceted approach that is required to develop successful combination products. Talks will cover a wide range of topics, including best practices for extractable/leachable testing, biocompatibility testing, future directions for combination products, and regulatory requirements governing the combination product platform space. We also hope to provide an atmosphere with the highly diverse audience can engage in informal conversations in the exhibit hall and during breaks.

The Workshop is designed specifically to bring key topics to the forefront, and to provide an open forum for discussion with colleagues and members of regulatory agencies. The wide breadth of subjects makes this forum appropriate for people working in combination product development and design, process validation, quality control, product testing and biocompatibility testing. It will be an excellent opportunity to learn about the current regulatory and corporate practices that are being used in the industry.


Brooke Schneider, CMP
Manager, Programs
Tel: (301) 656-5900 ext. 111

Registration Customer Care
Tel: +1 (301) 656-5900 ext. 115

Exhibition Inquiries
David Hall
Vice President, Sales
Tel: +1 (240) 688- 4405

Monday, October 2, 2017

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: Opening Plenary: The Future of Drug Delivery
Moderator: Diane Paskiet, Director, Scientific Affairs, West Pharmaceutical Services

Session Description: The product quality of drugs relies on the safety and compatibility of their container closure and delivery system. As the complexity of delivery systems and drug device combination products increases, the task of qualifying components fit for use becomes especially challenging. This session will give insight on how drug development is transforming the way primary packaging and delivery systems are viewed during development and throughout the product lifecycle.

8:30 a.m. – 9:00 a.m.
Considerations for Early Drug-Device Development
Didier Pertuy, Vice President, Global Head Drug Device Integrated Development, Sanofi

9:00 a.m. – 9:30 a.m.
FDA Approach to Facilitate Development and Implementation of Emerging Pharmaceutical Technologies
Sau (Larry) Lee, PhD, Deputy Director, Office of Testing and Research, CDER, FDA

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

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

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

10:45 a.m. – 12:15 p.m.
P2: Strategies for Safety Evaluation
Moderator: Ronald G. Iacocca, PhD, Research Fellow, Device and Delivery Research & Development, Eli Lilly and Company

Session Description: Biocompatibility testing is a growing area of interest in the development and registration of combination products. This session will focus on the basic concepts of biocompatibility testing for device platforms, as well as the strategies to execute them in a meaningful way such that excessive animal testing is not required.

10:45 a.m. – 11:15 a.m.
Approaches to Biocompatibility Evaluation of Combination Products
Kathleen Lin, PhD, Associate Senior Consultant Engineer, Eli Lilly and Company

11:15 a.m. – 11:45 a.m.
Clinical and Safety Parameters to Consider for Device-Drug/Biologic Combination Products
Khaudeja Bano, MD, Senior Medical Director, Abbott Diagnostics

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

12:15 p.m. – 1:30 p.m.
Networking Luncheon

1:30 p.m. – 3:15 p.m.
P3: Leachables and Extractables for Combination Products that Include Both Drugs and Devices
Moderator: Kim Li, PhD, DABT, MPH, Senior Manager, Amgen Inc.

Session Description: Chemical characterization is important for device-drug combination products. Risk of leachables and interaction products guides the analytical testing strategy. Extractables and leachables profiles are critical to qualifying these types of combination products, but the regulatory approaches can vary depending on the lead FDA center. There is one common purpose for leachables and extractables testing; that is to protect drug product quality and inform patient safety. This session will examine some of the different approaches to acquiring data and describes the PQRI strategy for safety thresholds and best practices.

1:30 p.m. – 1:50 p.m.
PQRI Strategy for Thresholds and Best Practices for Extractables and Leachables
Christopher T. Houston, PhD, Director of Analytical Chemistry, iuvo BioScience

1:50 p.m. – 2:15 p.m.
Biocompatibility Assessment of Medical Devices
Jennifer L. Goode, Biocompatibility Program Advisor, CDRH, FDA

2:15 p.m. – 2:45 p.m.
Chemical Characterizations of Materials

     Considerations of Extraction for Devices
     Matthew Woods,
Group Leader/Senior Chemist, Eurofins Lancaster Laboratories 

     Considerations of Extraction for Drug Packaging
     Piet Christiaens, PhD,
Scientific Director, Toxikon Europe 

2:45 p.m. – 3:15 p.m.
Panel Discussion
Piet Christiaens, PhD
Scientific Director, Toxikon Europe 
Jennifer L. Goode, Biocompatibility Program Advisor, CDRH, FDA
Christopher T. Houston, PhD, Director of Analytical Chemistry, iuvo BioScience
M. Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, CDRHFDA
Matthew Woods
Group Leader/Senior ChemistEurofins Lancaster Laboratories

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

4:00 p.m. – 5:30 p.m.
P4: Holistic Safety & Quality Assessment
Moderator: Ronald G. Iacocca, PhD, Research Fellow, Device and Delivery Research & Development, Eli Lilly and Company

Session Description: Safety assessment (i.e., toxicological evaluation) of leachables is a cornerstone of any pharmaceutical development program in which the issue of extractables/leachables is a concern. The session will begin with a discussion of background on the potential for safety concerns related to leachable substances, risk assessment considerations for human safety evaluation purposes,  and current initiatives/proposals for safety assessment of leachables. These recommendations provided toxicologists with a process to qualify extractables in parenteral products.

4:00 p.m. – 4:25 p.m.
Current Progress in Approaches for the Safety Assessment of Extractables and Leachables
Kim Li, PhD, DABT, MPH, Senior Manager, Amgen Inc.

4:25 p.m. – 4:50 p.m.
Review of the Extractables and Leachables Studies by the U.S. FDA: Practical Advice
Dan Mellon, PhD, Pharmacology Toxicology Supervisor, CDER, FDA

4:50 p.m. – 5:30 p.m.
Questions and Answers/Discussion

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

Tuesday, October 3, 2017

7:00 a.m. – 2:00 p.m.
Registration Open

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

7:15 a.m. – 8:15 a.m.
Packaging Science Interest Group
IG Leader: Roger Asselta, Vice President, Technical Affairs, Genesis Packaging Technologies

Session Description: This breakfast session will provide updates on current activities in the area of parenteral packaging, including Technical Reports, Tasks Forces, and regulatory Issues. It will provide an open forum for further discussion on this issue and additional topics of interest.

7:15 a.m. – 7:30 a.m.
Packaging Science Update

7:30 a.m. – 8:15 a.m.
Open Forum Discussion

8:30 a.m. – 10:00 a.m.
P5: Particle Challenges Associated with Delivery Systems and Devices
Moderator: M. Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, CDRH, FDA

Session Description: There is great a concern for contributions of particles from packaging components resulting in greater scrutiny of individual components. Understanding the sensitivity and uniqueness of particulate assessments will allow for an improved industry alignment on the subject. This session will focus current challenges associated industry initiatives for particulate evaluations and contributions from packaging components.

8:30 a.m. – 9:00 a.m.
Industry Initiatives for Visible Particulates Specifications: Pharmaceutical Manufacturers Forum 
Paolo Golfetto, Business Development Director, Ompi

9:00 a.m. – 9:30 a.m.
Impact and Consideration of Pharmaceutical Packaging on Particulates
Fran DeGrazio, Vice President, Scientific Affairs & Technical Services, West Pharmaceutical Services

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

9:45 a.m. – 1:45 p.m.
Exhibit Area Open

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

10:45 a.m. – 12:45 p.m.
P6: Compatibility of Delivery Systems with Biologics
Moderator: Nazia F. Rahman, Biomedical Engineer, CDRH, FDA

Session Description: A product formulation and its container closure must be chemically or biochemically stable to maintain the system’s integrity to be considered compatible. This session will explore correlation of biologic product quality with containment and delivery systems. This is a dynamic process that involves understanding suitability of delivery systems to preserve protein stability throughout the product lifecycle.

10:45 a.m. – 11:15 a.m.
Understanding Particulates from Formulation and Container Closure: Choosing the Right Techniques to Properly Assess Particle Profiles
Amber Haynes Fradkin, PhD, Director, Particle Characterization Core Facility, KBI Biopharma

11:15 a.m. – 11:45 a.m.
Qualifying Delivery System Platforms and Lifecycle Management
Susan Kirshner, PhD, Biologist, CBER, FDA

11:45 a.m. – 12:15 p.m.
Product Formulation – Package Interactions: Impact on Container Closure Integrity Evaluation and Risk Mitigation Approaches for Combination Products
Lei Li, PhD, Associate Senior Consultant Engineer, Eli Lilly and Company

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

12:45 p.m. – 2:00 p.m.
Networking Luncheon

2:00 p.m. – 4:00 p.m.
P7: Closing Plenary: Quality Considerations for Combination Products and Device
Moderator: Richard V. Levy, PhD, Senior Vice President, Scientific and Regulatory Affairs, PDA

Session Description: Specialty applications for drug delivery systems and devices continue to evolve and providing fit for use criteria is a challenge for suppliers. Compliance with national and international standards is a starting point but cannot encompass all uses. A set of baseline requirements will support suitability studies along with insight on quality expectations. This session will present the rationale, development, and content of the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) baseline requirements for materials quality, discussing engagement with suppliers, lifecycle implications, and relationship to risk-based concepts.

2:00 p.m. – 2:30 p.m.
A Device Perspective: Change Control for Marketed Combination Products
Kesley Gallagher, MS, Senior Regulatory Affairs Manager, Amgen Inc.

2:30 p.m. – 3:00 p.m.
Partnering across the Supply Chain to Develop and Communicate Risk-Based Requirements for Materials Quality
Lee Mia Nagao, PhD, Science Advisor, Drinker Biddle

3:00 p.m. – 3:30 p.m.
Regulatory Insight on Supplier Controls Regarding Quality of Delivery Systems
Nazia F. Rahman, Biomedical Engineer, CDRH, FDA
Isabel Tejero del Rio, MD, PhD, Lead Consumer Safety Officer, CDRH, FDA

3:30 p.m. – 4:00 p.m.
Questions and Answers/Discussion

4:00 p.m.
Closing Remarks from  Conference Co-Chair
Ronald G. Iacocca, PhD, Research Fellow, Delivery and Device Research and Development, Eli Lilly and Company

Workshop Registration | Oct. 2-3


Before Jul. 25, 2017

Jul. 25 - Aug. 21, 2017

After Aug. 21, 2017


Before Jul. 25, 2017

Jul. 25 - Aug. 21, 2017

After Aug. 21, 2017

Government/Health Authority/Academic


Before Jul. 25, 2017

Jul. 25 - Aug. 21, 2017

After Aug. 21, 2017


Before Jul. 25, 2017

Jul. 25 - Aug. 21, 2017

After Aug. 21, 2017



Before Jul. 25, 2017

Jul. 25 - Aug. 21, 2017

After Aug. 21, 2017


Before Jul. 25, 2017

Jul. 25 - Aug. 21, 2017

After Aug. 21, 2017

All prices in US dollars.

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

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 4 people from the same organization as a group (at the same time) for the Workshop and receive the 5th 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 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 August 3, 2017 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 at the prevailing rate. 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 August 3, 2017, 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 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.

Omni Shoreham Hotel
2500 Calvert Street NW
Washington, DC 20008
Phone: +1 (202) 234-0700

Rate: Single: $259.00, plus applicable taxes (14.5%).

Cut Off Date: Monday, September 4, 2017 (Availability may be limited. Requests will be processed on a first-come, first-served basis. Attendees staying within the PDA block will receive the conference rate.)

Hotel Accommodations

To make reservations at the Omni Shoreham Hotel, please call the Hotel at +1 (202) 234-0700 and reference the 2017 PDA Annex 1 Workshop, and the 2017 PDA Container Closure Workshop to receive the PDA group rate. Check in time is 3:00 p.m., and check out time is 12:00 noon.

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 by 12 p.m. three days prior to the date of arrival otherwise specified on your reservation information.


Since 1930, the luxurious Omni Shoreham Hotel in Washington, D.C. has played host to presidents, world leaders and inaugural balls, making it a true Washington landmark. The 834 luxury guest rooms are located steps away from the National Zoo. For a full list of hotel amenities - click here.


Area Airports
Ronald Reagan Washington National (DCA) is approximately 8 miles away. Two other airports in the vicinity are both serviced by all major carriers: Dulles International (IAD) is 28 miles away and Baltimore/Washington (BWI) is 34 miles away.

Ground Transportation
Taxi fares from Reagan National are $20-$25 one way, not including tip, and will take about 20 minutes. One way taxi fares from Dulles is $50-$65 and from BWI is about $75-$100.

Woodley Park Metro Station is 0.2 miles away from the hotel and is approximately $2.35-$3.25 one way to Reagan National.

Union Station is 4 miles away from the hotel. To book your reservation call Amtrak at 1 (800) 872-7245 or visit

Visit this page for detailed driving directions to the Omni Shoreham Hotel.

Hotel Parking
$49 / Valet parking only - per car, per day

The 2017 PDA Container Closure, Devices and Delivery Systems: Compatibility and Material Safety Workshop 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 Product Development, Process Validation, Quality Control, Product Testing, Biocompatibility Testing, Manufacturing, and Engineering.

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: