PDA Letter Article

SoCal Student Chapter Keeps Busy

by Christy Wong, Associate Director, Communications and Media of Southern California PDA Student Chapter, and Randy George, Southern California Chapter President

Student chapter poster

The student chapter within the Southern California Chapter does not have many slow moments as it works to meet the needs of its members who are beginning their careers in pharma. Since last fall, members have been kept busy by participating in main chapter events in addition to student-specific activities.

On Oct. 11, the Southern California Chapter’s Validation Symposium in Irvine, Calif. featured poster presentations from student chapter members highlighting lessons learned from their internship experiences the previous summer. These presentations served as an “add-on” for the main event, which covered current trends in process validation, data integrity and quality assurance.

The presentations also covered a variety of regulatory areas, from the creation of an IND to the completion of dossiers and 510(k) submissions a neuroendovascular medical device company. Poster presentations were judged as part of a contest; the winner received the chance to attend the 2019 PDA Annual Meeting as a chapter representative. The winner of the competition, Lyanna Jauregui, spoke on her role as a regulatory affairs intern for Proteus Digital Health. Last summer, she compiled a Drug Master File for U.S. FDA submission and aided Proteus Digital Health in submissions of technical and regulatory documents.

Jason Kerr (left) and Lyanna Jauregui (center) stand in front of Lyanna's poster with Chapter President Randy George (right)

In addition to their poster presentations, student chapter members had a chance to learn about process validation from industry leaders. Javier Cardenas, PhD, spoke about the concept of process validation. He introduced a four-stage model that precedes a process validation lifecycle approach. This model can be used to design, build and test the manufacturing process of products. Labeled the Validation V model, this four-stage blueprint consists of benchmarks for design, installation, operational and performance qualifications. Other speakers took on specific aspects of process validation. Lisa Lawson spoke about the risk management tools for ensuring patient and product safety, and William Honeck honed in on the pertinence of data integrity and management in regards to equipment, elaborating on actionable items that scientists should take towards producing proper data flow and back-up. Tara Scherder covered statistical methodologies for establishing the best possible manufacturing protocols, and Simona Millsdiscussed the importance of risk assessments on aging facilities and equipment.

Then, on Nov. 15, student chapter members had the opportunity to attend a networking event at Allergan that featured a panel discussion on women in the industry. Here, women from a variety of life science roles gathered to discuss their trials and successes.

Many panelists faced the challenge of establishing credibility in a historically male-dominated industry. Manjula Ghosh examined the dual importance of standing one’s ground while remaining even-tempered. This principle, as the panelists shared, can be applied in any professional situation but especially with negotiations. Mary Edwards spoke upon the value of mindfulness in becoming a good leader. By understanding others’ views and desires, the ability to deal with conflict, negotiate and effectively lead a team skyrockets.

Aside from career insights, the panelists also addressed their own motivations in pursuing science and supporting other women. Ziva Abraham, who now runs her own company, spoke about her personal goal to direct change in the world by creating an environment that fosters innovation at her company.

Supporting Pharma Young Professionals

Moving into 2019, the student chapter hosted its annual Career and Professional Development Conference at the Keck Graduate Institute (the educational body affiliated with the student chapter) in Claremont, Calif. The conference was open to both PDA members and the greater KGI student body. The event was highlighted by keynote industry speakers from a variety of backgrounds. During the event, the speakers covered a variety of topics including life science trends, professional speaking skills and career advice.

Paul Dionne opened with his talk, “Recruiting Tactics and Investigating Prospective Employers.” He drew from his experience as a recruiter to discuss best practices for resumes and cover letters, highlighting nuances in wording that give young professionals an edge during a job hunt. Next, Jason Kerr presented on the increasing use of artificial intelligence and natural language processing in helping answer real world regulatory affairs questions. His talk was followed by Ron Cohen’s presentation on the role of a pharmaceutical industry analyst. Keynote speaker, certified coach and image professional Patsy Cisneros capped off the exciting night with her talk on how to deliver a message with power, purpose and professionalism.

In addition, Southern California President Randy George and Student Chapter and Young Professionals Chapter Chairperson Jason Kerr recognized all the graduating members of the student chapter: Indah Kusumawardhani, Lyanna Jauregui, Revanth Srinivasan, Hinson Hui, Barath Muralidharan and Eric Benjamins. Each person was given a copy of the books The 7 Habits of Highly Effective People and Never Eat Alone and a certificate of recognition from chapter.

The student chapter thanks all the student volunteers, speakers and attendees for making these events a huge success.

PDA Who's Who

  • Ziva Abraham, CEO, Microrite
  • Eric Benjamins, Recent Graduate, Keck Graduate Institute
  • Javier Cardenas, PhD, Senior Engineer, Azzur Group
  • Patsy Cisneros, CEO, Corporate Icon
  • Ron Cohen, Vice President, GlobalData
  • Paul Dionne, Pre-Sales Solutions Engineer, Intellect Business Apps
  • Mary Edwards, Vice President of Regulatory and Clinical Affairs, Edwards Lifesciences
  • Randy George, Director of Sales, ValGenesis
  • Manjula Ghosh, Director, Aji Bio Pharma
  • William Honeck, Regional Manager, VTI Life Sciences
  • Hinson Hui, Recent Graduate, Keck Graduate Institute
  • Lyanna Jauregui, Recent Graduate, Keck Graduate Institute
  • Jason Kerr, QA Specialist, Amgen
  • Indah Kusumawardhani, Recent Graduate, Keck Graduate Institute
  • Lisa Lawson, Global Pharma GMP Advisor, Particle Measuring Systems
  • Simona Mills, Senior Manager, ProPharma Group
  • Barath Muralidharan, Recent Graduate, Keck Graduate Institute
  • Tara Scherder, Partner, Synolostats
  • Revanth Srinivasan, Recent Graduate, Keck Graduate Institute