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2018 PDA Packaging Science Interest Group Workshop

Apr 24, 2018
Bethesda, MD

  • Interest Group
  • Western Hemisphere Events


For the first time in the United States, PDA is hosting a one-day Packaging Science Interest Group Workshop. This Workshop will be a venue for the exchange of knowledge and ideas about pharmaceutical packaging. Participants will come together to discuss current topics in four facilitated sessions. Each session will be an open forum on the topic and attendees are encouraged to actively participate in the discussions. The session topics include: Container Closure Integrity, Packaging Components and Particulates, Alternative Materials of Construction for Packaging Components and much more.

Learning Objectives

At the completion of this workshop, the participant will be able to:

  • Engage in and discuss current issues with parenteral packaging
  • Identify best practices on in CCS development and implementation
  • Summarize current expectations for pharmaceutical product packaging and anticipate the trends in industry
  • Describe effective supplier relationship for product improvement
  • Find new analytical techniques that are being used to analyze bioproduct interactions with solid surfaces
  • Review recent developments in pharmaceutical packaging science

Who Should Attend

Persons involved in selection and utilization of parenteral packaging components and systems, including: Packaging engineers, quality and regulatory staff charged with evaluating, testing and qualifying packaging systems. Suppliers and regulators. Suppliers and developers of test equipment and methods.

Specifically, pharmaceutical and biopharmaceutical professionals with the following responsibilities are encouraged to participate: Quality Assurance | Packaging | Supplier Control | Packaging Suppliers | FDA Regulators | Product Development


Conference Inquiries
Jason E. Brown
Assistant Director, Programs
Tel: +1 (301) 656-5900 ext. 131, Email:

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

Exhibition inquiries
David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160, Email:


  • Tuesday, April 24

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

    7:30 a.m. – 12:15 p.m.
    Registration Open

    8:30 a.m. – 10:00 a.m.
    P1: Understanding Best Practices Relating to Container Closure Integrity
    Moderator: Fran DeGrazio,
    Vice President, Scientific Affairs & Technical Services, West Pharmaceutical Services, Inc.

    Session Description: This session will provide a review of challenges associated with assuring an integral primary container as well as the changing regulatory guidance and standards. Participants can join this interactive session which will allow discussion on all aspects of this subject. Topics to be covered include:

    • Annex 1
    • USP chapter 1207
    • Upcoming release of PDA TR 27
    • Industry experience and perspective

    9:45 a.m. – 3:45 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: Packaging Components and Particulates
    Moderator: Anthony Perry,
    Quality Director, SCHOTT North America, Inc.

    Session Description: This session will review the status and the ongoing work of the PDA Task Force “Achieving Zero Defects for Visible Particles.” During this session we will discuss the objectives of the task force, current status, and how this work relates to USP <790>.

    • Objectives
      • Establish a clearly defined particle specification (e.g., size, type and quantity) based on the risk of harm to patients
    • Current Scope
      • Ready-to-fill (RTF), ready-to-use (RTU), or ready-to-sterilize (RTS) materials and components
      • Glass containers; vials, syringes, and cartridges
      • Elastomer components; stoppers, plungers, and syringe tip caps
      • Secondary packaging associated with packaging components; bags
    • Ongoing Activities

    12:15 p.m. – 1:30 p.m.

    1:30 p.m. – 3:00 p.m.
    P3: Alternative Packaging Materials
    Moderator: Susan M. Dounce, PhD,
    Principal SME, Crystal Zenith, Prefilled Syringes, Combination Products, West Pharmaceutical Services, Inc.

    Session Description: This session will provide a review of challenges associated with traditional primary packaging materials as well as an overview of alternative materials of construction aimed at overcoming these challenges. Participants can join the open forum discussion which will address barriers and solutions to successful commercial implementation of non-traditional materials. Topics to be covered include:

    • Cyclic Olefin Polymers/Co-Polymers
    • Films and Coatings
    • Developments in Glass Technology
    • Blow-fill-seal Technology

    3:00 p.m. – 3:45 p.m.
    Refreshment Break in Exhibit Area

    3:45 p.m. – 5:15 p.m.
    P4: Panel Discussion
    Moderator: Roger Asselta, Vice President, Technical, Genesis Packaging Technologies

    Session Description: This session will provide opportunities to further discuss topics and further questions from the previous sessions will be addressed. In addition, participants will have the opportunity to voice additional topics that they want to discuss and provide input on the activities and direction of the interest group. Additional discussion items may include: relevant technical reports and regulatory guidance.

    5:00 pm
    Closing Remarks and Adjournment from Planning Committee Chair
    Roger Asselta, Vice President, Technical, Genesis Packaging Technologies

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • 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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Registration Fees

Early Registration
Regular Registration

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

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

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

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent by , no fee will be charged. After , a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent by , a full refund will be given minus a $200 fee. After , no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to Phone messages are not accepted.


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