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2018 PDA Packaging Science Interest Group Workshop

Apr 24, 2018
Bethesda, MD

  • Interest Group
  • The Americas

Overview

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

Contact

Conference Inquiries
Jason E. Brown
Assistant Director, Programs
Tel: +1 (301) 656-5900 ext. 131, 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 (301) 656-5900 ext. 160, Email: [email protected]

Agenda

  • 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.
    Lunch

    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.

Got a Question? We have answers

Contact Us

Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway
Bethesda, MD

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 U.S.A

From Ronald Reagan National Airport (DCA)

Take George Washington Memorial Parkway to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Metro option: Please refer to the "Public Transportation" section for details.


From Washington Dulles International Airport (IAD)

Take VA-267 E/Dulles Access Toll Road to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Bus/Metro option: Please refer to the "Public Transportation" section for details.


From Baltimore Washington International (BWI) Thurgood Marshall Airport and Points North

Take I-95 South to I-495 West (toward College Park/Silver Spring).
From I-495 West, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.

Bus/Metro option: Please refer to the "Public Transportation" section for details.


From the South

Take I-95 North to I-495 North (toward Maryland).
From I-495 North, take Exit 33 toward Chevy Chase.
Turn right onto East West Highway.
PDA is located within 4350 Bethesda Towers, which is to the left of and across from Bethesda-Chevy Chase High School.


Parking

Parking is available in the parking garage below Bethesda Towers for $12 a day. PDA does not validate parking. There are also public lots within walking distance of the facility.

Public Transportation

PDA is located on the red line at the Bethesda Metro station. Once on the street level, proceed two blocks east on East West Highway to 4350 Bethesda Towers. PDA TRI is located on the first floor.

PDA is accessible from all three airports in the area either by Metrorail, Metrobus, or both. Please see the Metro map below for details.

Metro System Map

The following hotels are conveniently located near PDA:

Hilton Garden Inn

7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
+1 (301) 654-8111

Special Hotel Rate: $192 (plus applicable taxes)

Please use the code N0033113 when making your reservation to receive the rate listed above (rates are subject to availability).


Hyatt Regency Bethesda

One Bethesda Metro Center | Bethesda, MD 20814 | 0.4 miles from PDA
+1 (301) 657-1234 / +1 (800) 233-1234 (US Only)

Special Hotel Rate: $189 (plus applicable taxes) | January-February, July-August, November-December

Special Hotel Rate: $225 (plus applicable taxes) | March-June, September-October

Please use the code 78056 when making your reservation to receive the rates listed above (rates are subject to availability).


Residence Inn Marriott Bethesda Downtown

7335 Wisconsin Avenue | Bethesda, MD 20814 | 0.4 miles from PDA
+1 (301) 718-0200

No special rates available.


DoubleTree by Hilton Hotel Bethesda

8120 Wisconsin Avenue | Bethesda, MD 20814 | 0.8 miles from PDA
+1 (301) 652-2000

No special rates available.


Hilton Rockville Hotel & Executive Meeting Center

1750 Rockville Pike | Rockville, MD 20852 | 7.0 miles from PDA
+1 (301) 468-1100

Special Hotel Rate: $169 (plus applicable taxes)

Please use the code N2703011 when making your reservation via phone. Rates are subject to availability.

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

Interest Group Registration | April 24, 2018

Member

By February 12, 2018
$650

After February 12, 2018
$850

Non-member

By February 12, 2018
$850

After February 12, 2018
$1,050


Young Professional Member

Member

By February 12, 2018
$325

After February 12, 2018
$425

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


Government/Health Authority

Member*

$300

Non-member*

$300

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


Academic

Member

$300

Non-member*

$300

* 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.

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 [email protected] 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 February 22, 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 February 22, 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 [email protected] 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.

* 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 [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, 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 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries
Registration Customer Care

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

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