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Parenteral Drug Association Connecting People, Science and Regulation ®

2018 PDA Endotoxins Workshop

Oct 17 - Oct 18, 2018 |
Oct 18, 2018 |
Bethesda North Marriott Hotel & Conference Center | Bethesda, MD
  • Conference
  • Western Hemisphere Events
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Endotoxin control of pharmaceutical API and biopharmaceutical drug substances or API production processes is a significant quality and compliance problem today.

Endotoxin, a cell wall component of gram negative bacteria, can cause varying levels of immune responses when introduced to the blood system. As a result, the onus is on the manufacturers of all parenteral drugs to control possible endotoxin contamination throughout the manufacturing process. As pharmaceutical manufacturing processes continue to become more streamlined and new therapy delivery continues to evolve, endotoxin control is evolving as well.

The 2018 PDA Endotoxins Workshop will provide scientific understanding and real-world practices for endotoxin testing in bio/pharmaceutical production processes.
Major topics to be covered will include:

  • Academic Perspectives on Immune Response to endotoxins
  • Low Endotoxin Recovery (LER)
  • Data Integrity
  • Beta-Glucans: Practical Issues Associated with Pharmaceutical Manufacturing
  • Non-LAL based endotoxin detection methods
  • BET Laboratories: Practical Advice

This Workshop will present practical approaches to endotoxin testing that participants can use in daily work and laboratory operations.

Learning Objectives

Upon completion of this Workshop, you will be able to:

  • Understand complex interaction of endotoxins with immune system.
  • Describe best practices for your company’s approach to address LER
  • Identify the best test method for endotoxin analysis for your company’s purpose
  • Recognize possible inhibitors and enhancers of the LAL test
  • Select appropriate endotoxin specifications for your company’s products
  • Describe best practices for your company’s new or existing laboratories

Who Should Attend

Department 
Biochemistry | Biology | Manufacturing | Microbiology | Development | Quality | Regulatory Affairs | Research | Technical Operations | Validation

Job Function 
Biologist | Microbiologist | Operator/Technician | Pharmacist | Product Manager | Scientist/Researcher

Conference Inquiries

Brooke Schneider, CMP
Manager, Programs
Tel: +1 (301) 656-5900 ext. 111
Email: schneider@pda.org

Registration Inquiries

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

Exhibition/Sponsorship Inquiries

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

Information coming soon.

Conference and Workshop Registration | October 15-18

Member

By August 4, 2018
$3,340

After August 4, 2018
$4,240

Non-member

By August 4, 2018
$3,819

After August 4, 2018
$4,719


Workshop Registration | October 17-18

Member

By August 4, 2018
$1,495

After August 4, 2018
$1,695

Non-member

By August 4, 2018
$1,695

After August 4, 2018
$1,895


Government/Health Authority

Member

By August 4, 2018
$700

After August 4, 2018
$700

Non-member*

By August 4, 2018
$800

After August 4, 2018
$800


Academic

Member

By August 4, 2018
$700

After August 4, 2018
$700

Non-member*

By August 4, 2018
$800

After August 4, 2018
$800


Student

Member

By August 4, 2018
$280

After August 4, 2018
$280

Non-member*

By August 4, 2018
$310

After August 4, 2018
$310


Young Professional Member †

Member

By August 4, 2018
$998

After August 4, 2018
$1,298

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 byAugust 16, 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 August 16, 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 Conferences.

Bethesda North Marriott HotelBethesda North Marriott Hotel & Conference Center
5701 Marinelli Rd
North Bethesda, MD 20852
Phone: +1 (301) 822-9200

Rate: Single: $269.00, plus applicable state and local taxes.

Cut Off Date: Monday, September 17, 2018 (Rooms must be secured by this date in order to receive the PDA rate). Rates are guaranteed until the PDA block of rooms are sold out on a first come basis.

Hotel Accommodations

To make reservations at the Marriott Bethesda North Hotel and Conference Center, please call the Hotel at +1 (301) 822-9200 and reference the PDA Meeting to receive the PDA group rate. Check in time is 4:00 p.m. and check out time is 12:00 p.m.

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 6:00 p.m. on the date of arrival otherwise specified on your reservation information.

Amenities

The Marriott Bethesda North Hotel & Conference Center is adjacent to the White Flint METRO Station on the RED line offering easy access to Rockville, Bethesda, Washington D.C. and Northern Virginia. All 220 guest rooms and suites provide high-speed Internet, upgraded Marriott Revive bedding, coffee makers, hair dryers, iron, and an ironing board. This hotel has a smoke-free policy and no pets are allowed.

Travel

Area Airports
Reagan National Airport (DCA) is approximately 20 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 30 minutes. One way taxi fares from Dulles is approximately $55 and from BWI about $75.

Driving
Bethesda North Marriott is located on Marinelli Road off of Rockville Pike in Rockville.

Metro
The Bethesda North Marriott is located on the RED line at the White Flint Station.

Hotel Parking
$15 Self Parking

Sponsorship and Exhibit Opportunities are Available!

The 2018 PDA Endotoxins Workshop offers exciting and unique sponsorship and exhibition packages designed to strengthen brand image, increase visibility, and help you connect with industry leaders. Attendees will include industry professionals from manufacturing, microbiology, development, biology, quality, regulatory affairs, technical operations, validation, and biochemistry.

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=3995

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