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

Irvine, CA
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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.

Day 1

  • 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
Agenda is subject to change.

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.

Hilton Irvine/Orange County Airport

18800 MacArthur Blvd
Irvine, CA ,

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.


d: + 1 949.812.3727
f:  + 1 949.833.3989
18800 Macarthur Blvd., Irvine, CA 92612