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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Texas Chapter: Science, Quality, and Manufacturing Half - Day Event

Nov 08 - Nov 08, 2018 |
Nov 08, 2018 |
Alcon | Fort Worth, TX
  • Chapter
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Join the PDA Texas Chapter on a tour of Alcon in Fort Worth, TX. This event will also include presentations and discussions from industry experts, and a networking luncheon with other attendees.

Speakers

  • Patti Parekh, CAI: Cleaning Validation Strategy as a Driver for Unplanned Process Changes:  A Combination Product Case Study.
  • Sean KerriganSTERIS: Sterilization Wrapping:  Principles and Best Practices.
  • Nicole Griffith, ICU Medical: Partnering with FDA Drug Shortage Staff to Prevent and Mitigate Drug Shortages.
  • Kevin Kane, Quotient Sciences: Real-time GMP manufacture of Injectable formulations for clinical development:  Where science and quality requirements meet.
  • 5th Presentation 2 FDA Speakers confirmed Additional information will be coming soon.
  • 8:30 - 10:00 AM Tours / Registration/ Networking / Vendor Exhibits
  • 10:00 - 10:45 AM"Partnering with FDA Drug Shortage Staff to Prevent and Mitigate Drug Shortages" 
    Presented by Nicole Griffith, Sr. Manager Regulatory Affairs, ICU Medical
  • 10:45 - 11:30 AM "Sterilization Wrapping: Principles and Best Practices"
    Presented by Sean Kerrigan, Senior cGMP Consultant, STERIS
  • 11:30 AM - 12:15 PM Lunch / Networking / Vendor Exhibits
  • 12:15 - 1:00 PM Presentation TBD
    Presented by two FDA representatives
  • 1:00 - 1:45 PM "Real-time GMP Manufacture of Injectable Formulations for Clinical Development: Where Science and Quality requirements meet."
    Presented by Kevin Kane, Scientific Director, Quotient Sciences Q&A and Chapter Business
  • 1:45 - 2:00 PM Break / Networking / Vendor Exhibits
  • 2:00 - 2:45 PM "Cleaning Validation Strategy as a Driver for Unplanned Process Changes: A Combination Product Case Study"
    Presented by Patti Parekh, Principal Consultant, CAI
  • 2:45 - 3:30 PM Panel Discussion
    All Presenters and FDA representatives
  • 3:30 - 3:45 PM Q&A / Closing Remarks

$60 - PDA Member

$70 - PDA  Non - Member

$35 - Student

$40 - Government

The PDA Texas Chapter event will be hosted by Alcon, located at:

6201 South Fwy,
Fort Worth, TX 76134

The Satellite Broadcast will be hosted by ICU Medical, located at:

3900 Howard Ln
Austin, TX 78728

Additional Venue Information:

  • Each registrant must bring photo identification to enter the campus and wear comfortable shoes for the tours.
  • Pictures are not allowed on the Alcon and ICU Medical Campuses.
  • Alcon and ICU are tobacco - free campuses (no smoking, etc. allowed within the fenced area).
  • Alcon and ICU sites are GMP Facilities with active operations, all visitors must  always be escorted by Alcon/ICU employees.
Register for one of our Sponsorship Packages listed below:
  • Platinum Plus Package: $1,000 and includes Sponsor recognition, tabletop displays at both locations, two free registrants, and 5 - minute company introduction.
  • Platinum Package: $750 and includes Sponsor recognition, tabletop displays at both locations, and two free registrants.
  • Gold Package: $500 and includes Sponsor recognition, tabletop display at one location (select during registration), and one free registrant.
  • Silver Package: $250 and includes Sponsor recognition.

Cancellations accepted within two weeks before the event for a 50% refund. PDA Texas Chapter will not honor refund requests after this date.

Name substitutions welcome. Please provide substitutions to Greg Williams.

If you have questions about registering or sponsoring, contact the event coordinator, Greg Williams.

Register Now
http://www.pdatexas.org/201811/

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