PDA Southern California Chapter - 4th Annual Full Day Aseptic Processing & Sterilization Symposium
Registration Options
Individual Registration
Group Registration
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.
Contact
Chapter Inquiries
Membership Services
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 Padala, Director 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> 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
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 BlvdIrvine, 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.
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