2013 PDA/FDA Container Closure Components and Systems Workshop

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Protecting Parenteral Drugs and Biologics Using Suitable Container Closure Systems
May 14-15, 2013 | Hyatt Regency Bethesda | Bethesda, Maryland
Exhibition: May 14-15 | Course: May 13

SPECIAL OFFER: Register for PDA/FDA's Container Closure Components and Systems Workshop and the PDA/FDA Glass Packaging Conference and receive $200 off your attendance.

Listen to a conversation with Ronald Iacocca, Diane Paskiet and Mihaela Simianu about the PDA/FDA Glass Packaging Conference and PDA/FDA Container Closure Components and Systems.

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At the 2013 PDA/FDA Container Closure Components and System Workshop, you will learn about the materials used in container closure systems and current advances to improve properties for current and future parenteral drug products from:

  • Ronald Forster, Director, Packaging Design/Engineer, Amgen, Inc.
  • Desmond Hunt, PhD, Senior Scientific Liaison, Standards Development, USP
  • Donald Klein, PhD, Senior Reviewer Chemist, ONDQA, CDER, FDA
  • Ingrid Markovic, PhD, Expert Review Scientist, CBER, FDA - Just Confirmed
  • Kalavati Survana, Microbiologist, DMPQ, Office of Compliance, CDER, FDA

Container Closure Systems must be suitable for continuously developing therapies and manufacturing technologies. The main pillars for suitability: protection, compatibility, functionality and safety take on new meaning as a maze of quality considerations emerge with the onset of risk based management couple with demands of innovative medicines.  This 1 1/2 day workshop will tie together a broad scope of attributes for container closure systems and potential impact to quality of therapies from the point of component selection, to the manufacture of medicine and delivery to patient.

Quality attributes span a wide spectrum of considerations and should be predetermined for intended use, established based on proven chemical, physical and functional characteristics.  This program will explore the requirements, trends and applications of quality expectations for container closure systems in relation to the patient expectations

Learning Objectives

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

  • Describe Materials used in the Manufacture of Parenteral Packaging Components
  • Explain Engineering  Packaging Components and their Delivery System  to meet Requirements of Today and Future Therapies
  • Validate the Manufacture of Parenteral Products to Secure  Integrity of  the Container Closure System
  • Discuss Insights Associated with Qualifying Components of  Combination Products
  • Explain the New Age of Protection and Safety of Drug Products During Storage and Distribution

Who Should Attend

Departments:

  • Formulation
  • Compliance
  • Engineering
  • Manufacturing
  • QA/QC
  • Regulatory Affairs
  • Packaging
  • Research and Development
  • Technical Operations
  • Validation

Level of Expertise:

  • Senior Management
  • Senior Scientists
  • Project/Program Leader
  • Technical Contributor
  • QA/QC

Job Function:

  • Materials Scientists
  • Packaging Engineers
  • Analytical Chemists
  • Toxicologists
  • Formulators
  • Product and Process Engineers
  • Regulatory
  • Biotechnology
  • Development
  • Procurement

Contact

Program Inquiries:

Leon D. Lewis
Director, Programs and Meetings
Tel: +1 (301) 656-5900 ext. 149
E-mail: lewis@pda.org

Registration Inquiries:

Patresa Day
Manager, Registration and Customer Service
Tel: +1 (301) 656-5900 ext. 115
E-mail: day@pda.org

Exhibit and Sponsorship Inquiries:

David Hall
Vice President, Sales
Tel: +1 (301) 656-5900 ext. 160
E-mail: hall@pda.org

  Before March 4, 2013 March 4-April 4, 2013 After April 4, 2013
Member $850 $1,050 $1,250
Nonmember $1,099 $1,299 $1,499
Government/Health Authority Member $ 700 $ 700 $ 700
Government/Health Authority Nonmember* $ 800 $ 800 $ 800
Academic Member $ 700 $ 700 $ 700
Academic Nonmember* $ 800 $ 800 $ 800
Student Member $ 280 $ 280 $ 280
Student Nonmember* $ 310 $ 310 $ 310

All prices in US dollars.

* For this member type, online registration is not available 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 conference and course.

Group Registration Discount

Register 4 people from the same organization as a group (at the same time) for the conference 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 Patresa Day at day@pda.org for help.

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.

Hyatt Regency Bethesda
One Bethesda Metro Center (7400 Wisconsin Ave.)
Bethesda, MD 20814
Phone: +1 (301) 657-1234

Website: www.bethesda.hyatt.com

Rate: Single: $209.00, plus applicable state and local taxes.
To reserve your room: Please contact Catherine Akerstrom at +1 (301) 657-6423

Hotel Accommodations

PDA is excited to host the 2013 PDA/FDA Container Closure Components and Systems Workshop and PDA/FDA Glass Packaging Conference at the Hyatt Regency Bethesda.  A block of rooms have been reserved at the group rate of $209 single plus applicable state and local taxes. Reservations can be made on a space and rate available basis only.

To make reservations at the Hyatt Regency Bethesda, please call the Hotel at +1 (301) 657-6423 and reference the 2013 PDA/FDA Container Closure Components and Systems Workshop and PDA/FDA Glass Packaging Conference receive the PDA group rate. Check in time is 4:00 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 3 p.m. one day prior to arrival otherwise specified on your reservation information.

Area Hotels within Walking Distance to Hyatt Regency Bethesda 
Please note: PDA is not holding rooms.  All rates and rooms are based on availability (As of April 22, 2013).

Residence Inn Marriott Bethesda Downtown (0.08 miles away)
7335 Wisconsin Avenue | Bethesda, MD 20814 | 0.4 miles from Hyatt Regency Bethesda
+ 1 (301) 718-0200
Standard Room Rate: $289.00 (plus applicable taxes)
To book your reservation, please call the hotel directly or visit their website.

Hilton Garden Inn (0.1 miles away)
7301 Waverly Street | Bethesda, MD 20814
+ 1 (301) 654-8111
Standard Room Rate: $229.00 (plus applicable taxes)
To book your reservation, please call the hotel directly or visit their website.

DoubleTree by Hilton Hotel Bethesda (0.5 miles away)
8120 Wisconsin Ave. | Bethesda, Maryland, USA, 20814
+1 (301)-652-2000
Standard Room Rate: $269.00 (plus applicable taxes)
To book your reservation, please call the hotel directly or visit their website.

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. All 390 guest rooms and suites provide high-speed Internet, Hypo-Allergenic room purification, coffee makers, hair dryers, iron and an ironing board.

Travel

Area Airports
Reagan National Airport (DCA) is approximately 12 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International, 24 miles away, and Baltimore-Washington International, 34 miles away.

Ground Transportation
Taxi fares from DCA are approximately $55 one way, not including tip, and will take about 15 minutes. One way taxi fares from Dulles is approximately $65 and from BWI about $75. 

Driving
The Hyatt Regency Bethesda is located on Wisconsin Avenue.

Metro
The Hyatt Regency Bethesda is located on the RED line at the Bethesda Station.

Hotel Parking
$20 Self Parking
$25 Valet Parking

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.

High impact, cost-effective sponsorship and exhibition packages are available for the 2013 PDA/FDA Container Closure Components and Systems Workshop. Gain on-site exposure and connect with industry experts from Quality Assurance, Packaging, Formulation, Compliance, Engineering, Product Development, Manufacturing, and Regulatory Affairs. This year’s Workshop will provide critical information on attributes for container closure systems and potential impact to quality of therapies from the point of component selection, to the manufacture of medicine and delivery to patient  – making it a must attend event.

The conference agenda provides ample time for exhibitors to make new contacts, network with attendees, gain new business relationships, connect with key industry leaders, and improve your sales.

In addition, comprehensive sponsorship packages will provide your company the opportunity to strengthen brand image, increase visibility, and reinforce its commitment to the biopharmaceutical industry. Sponsorships are also available for lanyards, USBs, notepads, pens, refreshment breaks, lunch, and networking reception.

For more information about exhibits and sponsorships, contact David Hall at +1 (240) 688-4405 or hall@pda.org.

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