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Parenteral Drug Association Connecting People, Science and Regulation ®

2018-2020 Chapter Officers

Chapter President

Randy George
Sales Director
ValGenesis, Inc.

President, 2018-2020
Co-Chair Person, Programs, 2018-2020

Randy George currently serves as the West Coast Sales / Account Director for ValGenesis, a position he has held since February 2018. ValGenesis is the leading provider of validation software to the life science and regulated industries; and the only company to receive PDA's New Innovative Technology Award for being a first innovative software platform for electronic validation.

His experience in the life science industry began in 2007 working in various sales and business development roles, offering products, capital equipment, automation, quality management software, and services. As a member of PDA and the SoCal PDA Board of Directors, he has held various positions and responsibilities supporting the chapter's programs and initiatives. From vendor out-reach and vendor night coordinator, to membership and corporate outreach, he credits his time with PDA for making a successful career transition into the life science industry.

Randy earned a degree in Public Justice form SUNY at Oswego with minors in Sociology, Psychology and Social Work, and spent 8 years with the Los Angeles Police Department as a reserve police officer. He also worked in the wine industry and was previously involved with Gulleyan Winery.
Prior to his involvement in life sciences, Randy has over 15 years' experience in various management positions, including sales and business development. His experience also includes consumer product manufacturing, packaging, capital equipment, automation, quality assurance and quality control. Benefiting from an extensive amount of management and sales training throughout his career, Randy has spent many years working with European companies developing new markets and sales opportunities in the US.

Randy is currently on the planning committee for the 2019 PDA Annual Meeting.

Chapter President-Elect

Sheba Zaman
Head of Product Specialists and Training Services
Novatek International

President-Elect, 2018-2020
President, 2020-2022
Chair Person, Speaker Outreach, 2018-2020
Co-Chair Person, Programs, 2018-2020

Sheba Zaman has been serving in a technical role at Novatek International for over 17 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade to establish procedures, work instructions, validation scripts and training program related to their data management systems.

Chapter Secretary

Tita Tavares
Sales Manager, Professional Services
PSC Biotech

Secretary, 2018-2020
Chair Person Events & Venues, 2018-2020

As a committed business professional, Tita provides comprehensive planning skills with the organizational ability to simultaneously manage many responsibilities. With over 10 years of success in business operations and development, she shares her experience in the Life Sciences Industry where she works to problem-solve technical challenges of manufacturing complexities. She currently works for PSC Biotech as the Sales Manager for Professional Services.

Tita has been involved with PDA for most of her career in the Industry as an event exhibitor, PDA Association member and now sits on the PDA Southern California Chapter as the Secretary and Vendor Outreach Chair.

Understanding the value that PDA brings to the Biotech and Pharma world, she strives to share the wealth of knowledge found in PDA technical reports, training and educational courses, and scientific and regulatory resources with colleagues and other Life Science professionals in hopes of continuously improving the way that we manufacture and produce lifesaving treatments within our communities.

Chapter Treasurer

Greg Mills
Director
AxR Tech

Treasurer, 2018-2020

Greg Mills is the Development Director for AXRTECH since 2009 and working in the contamination control in life sciences and chemical processing, and over thirty years in the high technology field in process engineering.

Greg holds an MS in Engineering Management from Santa Clara University and a BA in Chemistry from Illinois College. He has worked various fields in QA/QC engineering functions plus strategic product development and technical marketing, internationally and of course domestically, as profit centers. The bulk of his career has been in management and executive roles across several organizations in marketing and custom product development in close cooperation with Asian and European companies.

Greg Mills is very active in his community with continuing Rotary International, Booster Club, city council, and special districts, to further enhance an even more rounded professional development and acumen for the benefit of organizations. Mr. Mills is keen to assist in continuing an exceptionally relevant, solvent and vibrant PDA for our SoCal PDA membership.

Chapter Members-at-Large

Amy Stanton
Quality Systems Specialist
Amgen, Inc.

Member-At-Large
Committee Member, Speaker Outreach & FDA Liaison

Since 2003 Amy has held multiple positions within the Quality Organization at Amgen, most recently as a Quality Systems Specialist in External Affairs. While at Amgen she worked to develop, implement and helped to maintain the GMP Regulatory Intelligence Program, which includes surveillance, analysis and communication of GMP related regulations, guidance and enforcement activities. She is co-founder of the Regulatory Intelligence Discussion Group (RIDG), an industry group working together sharing best practices and knowledge in relation to GMP and GDP Regulations. She is an active member of PDA and other industry and local organizations. Previously Project Manager (PM) for PDA Technical Report No. 74 Reprocessing of Biopharmaceuticals and currently, PM for the PDA Team on Achieving ″Zero″ Defects for Visible Particles in Injectables. Amy received both her Bachelor of Science and her MBA from California Lutheran University.

Gary Thurner
Particle Measuring System
Western Region Sales Manager

Member-At-Large
Chair Person, Membership & Corporate Outreach

Over 20 years' experience in pharmaceutical raw material supply chains and sterility assurance, primarily with Spectrum Chemical and Thermo Fisher. Currently assisting Particle Measuring Systems client's with technology-driven environmental monitoring process improvements using scientific methods, while achieving GMP compliance and regulatory approvals. Over the last 5 years Gary has been involved in initiatives bringing cutting edge Process Analytical Technologies and Rapid Microbial Methods that improve quality and process to the life sciences community.

Herb Matheson
President
Validation Technologies, Inc.

Member-At-Large
Chairperson, Vendor Outreach
Committee Member, San Diego Events & Program Committee

Mr. Matheson has been working within the Life Sciences industry for over 35 years after graduating from Michigan State University with a B.S. in Microbiology and Public Health. During that time, he has worked for both operating companies and service providers within the Engineering and Quality Assurance departments in positions mostly related to the commissioning and qualification of facilities and processes.
For the past 23 years he has been the co-founder and President of VTI Life Sciences (formerly Validation Technologies) and has been responsible for providing commissioning and qualification services to companies within the FDA regulated life science industries both within the United States and internationally.

I look forward to bringing my experience as a service provider and as a business owner who recognizes the importance of professional development to employees, to assist the SoCal PDA to provide continuing education to professionals involved in the pharmaceutical and biopharmaceutical industry.

Indah Kusumawardhani
Graduate Student
KGI Graduate Institute

Member-At-Large
Student Chapter President, 2018-2019
Committee Member, Events & Programs

Indah is a second-year Master of Business and Science student, majoring in Regulatory Affairs at KGI. She obtained her Bachelor of Science in Molecular Environmental Biology from University of California, Berkeley. Prior to KGI, Indah worked as an Immunology Research Associate at a diagnostic reagents company. She also had the opportunity to perform a pre-clinical study on microbiome and Crohn's disease at Sarkis Mazmanian Lab, Caltech in collaboration with AbbVie Inc. She is currently doing her regulatory affairs summer internship at MicroVention Inc. As the President for the SoCal PDA Student Chapter, Indah is dedicated to advancing the chapter's mission by connecting KGI community with professionals in the life science industries.

Jason Kerr
QA Specialist
Amgen, Inc.

Member-At-Large
Chairperson, Student Chapter & Young Professionals

Jason Kerr is a QA Manager at Amgen's External Affairs Quality department and stays up to date on GMP changes in the global landscape. Prior to Amgen, Jason has worked with Shire Pharmaceuticals for two years in material qualification for extractable and leachable on single-use systems and raw material validation. He received his Bachelors in Biochemistry from UCLA in 2014 and his master's in business and Science (MBS) focusing on Clinical and Regulatory Affairs from the Keck Graduate Institute (KGI) in 2016. He also holds a Certificate in Bioscience Industry Law and Practice from the Southwestern Law School in 2016 and received his MBA through Smartly in 2017.

Jason is currently on the planning committee for the 2019 PDA Annual Meeting representing Young Professionals.

Molly Blazek
Regional Sales Manager, Western US
Oceasoft

Member-At-Large
Committee Member, San Diego Events & Program Committee
Committee Member, Student Chapter & Young Professionals

Molly Blazek is the Regional Sales Manager for the Western U.S. for OCEASOFT, an environmental monitoring company specializing in wireless sensors and data transmission, data integration in back-end information systems, calibration, IOT and software platform development. Molly has been in the life science industry for 6 years, starting with data management at the Salk Institute for Biological Sciences. She is an active member of PDA, assisting with the development of San Diego and the Student Chapter/Young Professionals. Molly obtained her Bachelor of Arts and Master of Arts at University of California, San Diego, and San Diego State University, respectively.

Tom Hunter
Business Development Manager
ProPharma Group

Member-At-Large
Committee Chair Person, San Diego Events & Program Committee

Chapter Volunteers

Annmarie Duran
Director, Patient Development
O2 Solutions

Chapter Volunteer
Committee Member, Philanthropy & Donations and Events & Venues

Chapter Advisors

Bonnie Ward
President & CEO
Quality Compliance Partners, Inc.

Past Chapter Board Member
Chapter Advisor, Events, Programs & Speaker Outreach

Bonnie Ward is President & CEO of Quality Compliance Partners, Inc., a quality and regulatory compliance consulting firm providing quality systems, quality assurance, audit, validation/qualification, training and regulatory support services. She has over 25 years' experience in the life science, high-tech and financial industries with both private and public companies. She is an active member of PDA and other industry and local organizations. Bonnie served on the PDA SoCal Board for 5 years, as well as serving as President of SDRAN (San Diego Regulatory Affairs Network) and on the Board for 5 years. Bonnie received a Bachelor of Business Administration degree from the University of Wisconsin-Madison, and a Master of Science degree from University of Colorado – Denver.

Gerard Pearce
SQA Services, Inc.
Executive Vice President at SQA Services, Inc.

Chapter Advisor, Communications, Marketing and Events & Programs

Gerard is a quality and supply chain expert with over 25 years of experience in combining the disciplines of quality, technology and supply management. His expertise spans a variety of quality-critical industries in a global manufacturing landscape. For the last 15 years, he has focused on defining the processes and infrastructure that provides managed supplier quality programs for numerous global leaders in the fields of pharmaceuticals, defense, medical devices, oil & gas, electronics, aerospace, consumer goods, and more. Central to this infrastructure is the technology required for effectively running global supplier quality operations by connecting all stakeholders in the supply chain. Currently the executive vice president and head of operations with SQA, Gerard is a regular industry commentator and contributor, and is closely involved in shaping and implementing the global supplier quality strategy for SQA's Fortune 500 clients.

John Holmgren
Director Quality / Validation
Allergan

Past Chapter President
Chapter Advisor, Events, Programs & Speaker Outreach

Laurel Hacche
Senior Quality Professional
SQA Services, Inc.

Past Chapter Board Officer
Chapter Advisor, Events, Programs & Speaker Outreach

Laurel Hacche is the President of Manufacturing & Quality Consulting with over 25 years of experience in the pharmaceutical, device, cosmetic, and biologics industries. Dr. Hacche provides consulting services for the life science industries with a focus on third party assessment, qualification, and maintenance, quality assurance systems, compliance auditing, pre-approval inspection preparation, Corrective and Preventive Action (CAPA) systems, and GMP training. Prior to her role as a consultant, Dr. Hacche was the Senior Director of Third-Party Manufacturing in the Global Sourcing & Procurement department at Allergan, Inc. During her tenure with Allergan, she served as the Director of Worldwide Quality Assurance with oversight for the corporate CAPA system, annual product reviews, government agency communication records, third party manufacturers, the global audit and stability programs, complaint management, and R&D technology transfer. In addition to the above activities, Dr. Hacche served as the lead corporate QA liaison for the FDA and alternate regulatory agencies. Prior to Dr. Hacche's employment at Allergan, Inc., she served as a Postdoctoral Researcher in the Department of Biological Chemistry at the California College of Medicine at U.C. Irvine. Dr. Hacche has also held an Associate Faculty position at Saddleback College and served as an Assistant Professor at the Joint Science Department for the Claremont Colleges. Dr. Hacche holds a Ph.D. in Physical Polymer Chemistry from U.C. Irvine and an A.B. in Chemistry from Occidental College.

Stephanie Powers-Kurtz
Regional Sales Manager
Eurofins Lancaster Laboratories

Past Chapter Board Officer
Chapter Advisor, Philanthropy & Donations and Speaker Outreach

Stephanie Powers Kurtz is the Southern California Regional Sales Manager for Eurofins Lancaster Laboratories. With Eurofins since 2017, Stephanie has over seven years of sales and business development experience in the pharmaceutical and biopharmaceutical industries. Stephanie earned a Bachelor of Science in Biology from Villanova University and a Master of Science in Education from Saint Joseph's University. Prior to moving into an Advisory role with the SoCal PDA Chapter, Stephanie held the positions of Treasurer and Chair of Philanthropy and has been a PDA member since 2011.

Tony Steinberg
Global Project Manager
Illumina

Past Chapter Board Member
Chapter Advisor, Events, Programs & Speaker Outreach