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PDA Southern California Chapter - 4th Annual Full Day Aseptic Processing & Sterilization Symposium

Nov 07, 2019
Irvine, CA

  • Chapter
Closed

Overview

PDA SoCal Chapter invites you take part in a technical and educational symposium full day conference of presentations and teachings on current industry topics and best practices presented by SME’s, including FDA, a keynote speaker and case studies.

During this program, the SoCal PDA Chapter will also be hosting a student and young professionals poster competition.

Agenda

    • 6:30 a.m. - 7:30 a.m. Registration Opens for Women Leaders in Life Sciences - Breakfast
    • 7:30 a.m. - 9:00 a.m. Women Leaders in Life Sciences - Breakfast & Panel Discussion
      Moderator: Stacy Sutton, Vice President, Quality Assurance, Argonaut Manufacturing Services
      Panelists: Regina Atim, PharmD, MBA, BCMAS‐Human Factors Engineering Pharmacist ‐ Becton Dickinson, Associate Clinical Professor‐University of San Diego, Chair & Academic Alliance‐HIMSS Southern California
      Indah Kusumawardhani, Clinical & Regulatory Development Program Associate, Edwards Life Sciences
      Vanessa Marquez, QC Manager Microbiology, Sorrento Therapeutics
      Cynthia Martinez, PhD., Dean of Students, Keck Graduate Institute
    • 7:30 a.m. - 9:30 a.m. Registration Opens for Aseptic Day 
    • 8:00 a.m.-  9:30 a.m. Networking & PDA Opening Announcements
    • 9:30 a.m.- 10:15 a.m. Kick Off - Keynote speaker - Annex 1
      Hal Baseman, Principal/COO, ValSource
    • 10:15 a.m. - 11:00 a.m.
      Track 1: Aseptic Operations & Cleanroom Behaviors
      Paul Andrea, Principal Consultant, TAF Consulting,LLC
    • Track 2: Methods of Sterilization
      Christopher Fenton, Manufacturing Manager II, B Braun
    • 11:00 a.m. - 11:15 a.m. Networking Break / Student Poster Presentations
    • 11:15  a.m. - 11:45 p.m.
      Track 1: Innovations in Continuous Microbiological Environmental Monitoring
      Carol Julich, Sales Specialist, TSI
    • Track 2: Steam Sterilization “What we need to know to comply with EN285-A Case Study”
      Ron Mirian, SoCal Regional Manager, VTI Life Sciences
    • 11:45  a.m. - 12:30 p.m.
      Track 1: Media Fills/Aseptic Process Simulation and Validation
      Manjula Gosh, Director Quality, Allergan
    • Track 2: Equipment for Sterile Manufacturing
      Les Edwards, VP, Technology and Business Development, SKAN
    • 12:30  p.m.- 1:30 p.m. Lunch & Vendor Announcements
    • 1:45 p.m. - 2:30 p.m.
      Track 1: Application of Single Use Technologies to Aseptic Processing

      Mike Alston, Jr.,Director Project Engineering, Avid BioServices
    • Track 2: Cleaning/Disinfection of Cleanrooms
      Jim Polarine, Sr. Technical Services Manager, Steris
    • 2:30 p.m. - 3:15 p.m. 
      Track 1: Innovations in Aseptic Processing

      Chakradhar PadalaDirector Process Development, Amgen
    • Track 2: Application of Single-Use Technologies in Final Filling Applications 
      Jessica Frantz, Technology Expert – Aseptic Transfer Systems, Sartorius Stedim North America
    • 3:15 p.m. - 3:30 p.m. Networking Break / Student Poster Presentations
    • 3:30 p.m. - 4:15 p.m.
      Track 1: Environmental Monitoring & Aseptic Processing - Technology & Microbiology
      Paul Hartigan, Global Product Line Manager for Software and Systems, PMS
      Stacy Sutton, Vice President Quality Assurance, Argonaut Manufacturing Services
    • Track 2: Quality Risk Management Principles as Related to C&GT and CAR T
      Will Junker, Global Head, Quality Engineering , Kite Pharmaceuticals
    • 4:15 p.m. - 5:00 p.m.  Case Studies
      Track 1: New Vial Filling Line Installation – End-to-End
      Norman Nicklaus, Principle Validation Engineer, Amgen
      Eric Berg, Director of Quality, Amgen
    • Track 2: NextGen Now – The Future of Advanced Therapy Medicinal Products (ATMP) Facilities
      Peter Walters, , Lead Process Engineer, CRB
      Brita Salzmann, Process Engineer, CRB
    • 5:00 p.m. - 6:00 p.m.  End-Of-Event Networking Reception + Student Poster Announcement Winner + Raffle + PDA Closing Remarks

Highlighted Speakers

Hal Baseman
Hal Baseman
ValSource LLC
Jim N. Polarine
Jim N. Polarine
STERIS Corporation

Travel

Hilton Irvine/Orange County Airport

18800 MacArthur Blvd
Irvine, CA

  • Accommodations

    Should Speakers, Exhibitors or Attendees require lodging, a block of rooms have been set aside at the Hilton Hotel for this event. The room block will expire on October 16th for advance reservations.

    You may contact the hotel directly (see below) and mention your with the SoCal PDA Chapter Event on Nov. 7th, 2019 or click on the following link, it will take you directly to the SoCal PDA Chapter reservation site, it is very user friendly.

    HILTON IRVINE/ORANGE COUNTY AIRPORT

    d: + 1 949.812.3727
    f:  + 1 949.833.3989
    18800 Macarthur Blvd., Irvine, CA 92612 
    www.irvineorangecountyairport.hilton.com

  • Amenities

Directions

Registration Fees

Early Registration Price
Registration Type Price By No 5th
Member $300.00
Non-Member $350.00
Gov't, Students, and Young Prof. $200.00
Registration Type Price
Women In Bio Breakfast (With Event Registration) $30.00
Women In Bio Breakfast (Breakfast Only) $50.00
Regular Registration Price
Registration Type Price after Nov 6th
Member $350.00
Non-Member $400.00
Gov't, Students, and Young Prof. $250.00
Registration Type Price on Nov 7th
Member (Walk-In) $400.00
Non-Member (Walk-In) $450.00
Gov't, Students, and Young Prof. (Walk-In) $300.00
Registration Type Price
Women In Bio Breakfast (With Event Registration) $30.00
Women In Bio Breakfast (Breakfast Only) $50.00
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