PDA Letter Article

PDA SoCal Chapter Two-Year Update

by Stephanie Lee, Amgen Inc.

The PDA Southern California Chapter has been busy in the last two years offering valuable and relevant events for our members, sponsors, and guests, while also keeping up the camaraderie of our group of volunteers. The all-volunteer Board of Directors, led by President Sheba Zaman, Novatek International (since September 2020) never missed a beat despite COVID-19-related restrictions, meeting virtually almost every week to keep the chapter busy.

In 2021, PDA SoCal continued offering virtual events, which became standard in 2020, and cautiously planned an in-person event after the rollout of the COVID-19 vaccines. With the blessing of southern California weather, we were proud to be one of the first chapters to safely sponsor an in-person event later in June 2021. In total, the PDA SoCal Chapter managed to hold five events in 2021: three virtually and two in-person.

We kicked off 2021 by hosting a joint webinar with OCRA (Orange County Regulatory Affairs) to discuss “The New Paradigm: Inspections During COVID” in February. This is a highly relevant topic with remote audits necessitated during the pandemic. We heard from distinguished speakers Kimberley Buytaert-Hoefen, PhD, formerly FDA & Azzur Group (now with QPS Holdings, LLC), Angela Bazigos, Touchstone Technologies, Inc., Karine A. Lux, The Jackson Laboratory, and Aaron Rose, PhD, The Jackson Laboratory. The event included discussions of handling document and onsite audits, how the onsite auditor was able to successfully get information to a company, and the perspective of a company being audited remotely.

A few months later in May 2021, we cosponsored “Insights from Women in Life Sciences” with the PDA Capital Area Chapter. The following female industry leaders joined the panel in 2021:

  • Nina Mezu-Nwaba, PharmD, MPH, MSc, FDA/CDRH
  • Michelle Stecklein Call, Redica Systems
  • Whitney Kutney, ValSource, Inc.
  • Lynne Cooper, PMS at Facility Logix, LLC
  • Hang Zhang, PhD, On Demand Pharmaceuticals

The panel engaged in a dynamic conversation about current industry topics and trends including Emergency Use Authorizations (EUAs), Premarket Approvals (PMAs), and regulatory compliance, managing health disparities, as well as thoughtful dialogue on the future of women in the workplace post-pandemic.

Next, we had an overwhelming turnout for our first in-person event in June 2021. It began with a facility tour of Azzur Cleanrooms On Demand’s brand-new, state-of-the-art facility. That was followed by networking at Dogleg Brewery. It was wonderful to see our members, sponsors, and guests while touring Azzur’s new facility and learning more about their ISO-classified cGMP-compliant cleanroom spaces.

In July 2021, the PDA Southern California Chapter hosted a Virtual Tour of Amgen’s continuous manufacturing operation. Amgen’s Neil Soice, PhD, and Matthew G. Beaver, PhD, provided the “tour.” With Neil’s expertise in drug substance technology and Matthew’s proficiency in pivotal and commercial synthetics, we learned how continuous manufacturing has emerged as a compelling alternative to traditional batch processing for both small and large molecule pharmaceutical production. We virtually toured Amgen’s development facilities while learning more about Amgen’s approach and innovation within the continuous manufacturing space.

We concluded 2021 with our marquis event at The Grand in Long Beach—our tenth annual Industry Summit & Exhibitor Showcase (Vendor Night). This was our second in-person event of the year, taking place outdoors with distancing measures. Attendees enjoyed hors d’oeuvres, drinks, and dinner along with a program of expert presenters. Tayl'r Hollis, Regulatory Compliance Associates, Inc., presented “Operational Excellence during Virtual Audits,” and Robert Nichols, Azzur Group, delivered “Asset Lifecycle Management and Continuous Improvement.” We had a “grand” time learning from our speakers, speed networking, and seeing our gold and silver sponsors, exhibitors, and special partners.

The PDA SoCal Chapter Board continued the momentum in 2022, with thoughtful planning by our dedicated Board and volunteers.

PDA SoCal Board and volunteers planning 2022 Our PDA SoCal Board and volunteers planning 2022 on a rare SoCal rainy day!

The PDA SoCal Chapter held our first event of 2022 on March 8, International Women’s Day – the Full Day Symposium: Risk Management and Women in Life Sciences Panel, to celebrate International Women’s Day. The panel included:

  • Kimberley Buytaert-Hoefen, Azzur Group
  • Linda Soo Hoo, Gilead
  • Biana Torres, Crispr Therapeutics
  • Teresa Henry, Sequoia Consulting.
  • Sheba Zaman (moderator), Chapter President/Novatek International
Sue Schniepp, PDA Chair, addressing the panel at an oudoor event Sue Schniepp, PDA Chair, addressing the panel on International Women’s Day 3/8/2022.

We started off the day with our keynote speaker, Sue Schniepp, Regulatory Compliance Associates, Inc. and PDA Chair, who presented “Why Quality Culture is Important.” Several other speakers presented on a variety of relevant topics. We had a fantastic time learning from all our panelists and got many insightful questions from our audience.

In June 2022, we hosted a Summer Networking event at the Draft Republic in Carlsbad, CA. The PDA SoCal Chapter enjoyed a nice cold draft with our friends and colleagues. It was refreshing to see familiar faces and connect with newer members and guests.

In September 2022, we held our 11th Annual Industry Summit & Exhibitor Showcase (Vendor Night) at the Long Beach Museum of Art, with guests enjoying an evening with informative presentations, good company, and a beautiful view of the ocean. Attendees were able to network and learn about the latest in new technologies from our exhibitors and speakers.

On November 8, 2022, we proudly presented an evening program at Open Biopharma in the Carlsbad area, called “Spotlighting Contract Manufacturing Organizations (CMOs).” Jennifer Vavala, Ajinomoto, Laura Freeman, Bioserv Corp, Gary Pierce, ServareGMP, and Roger Lias, Wheeler Bio, made informative presentations. We were eager to learn more about new CMO opportunities, new techniques, and the future of CMOs at this special evening program.

We also have two highly anticipated upcoming events: a Holiday Philanthropic Event at the end of the year, as well as a full-day program on Contamination Control Strategies on March 8, 2023. The latter event typically comprises of 12 to 15 speakers, with many topics to discuss including the recent Annex 1 revision.

We are excited to close out the 2022 year strong and look forward to seeing more of our members, sponsors, and guests in the upcoming year!

11th Annual Industry Summit on the lawn of the Long Beach Museum of Art Long Beach Museum of Art, PDA SoCal’s 11th Annual Industry Summit on 10/20/2022.

About the Author

Stephanie LeeStephanie Lee is a CMC Project Manager in Process Development at Amgen, with projects supporting lifecycle management, combination products, and clinical/commercial development. She is an active volunteer in the PDA SoCal and West Coast Chapters, is participating in the PDA ECP Mentorship Program, and was previously the PDA SoCal Student Chapter President.