PDA West Coast Chapter: Full Day Quality Conference

Featured Presenters

• 

  Frederic B. Ayers

  Senior Consultant - Microbiology, ValSource, Inc.

  Read Bio

  

  Frederic B. Ayers

  ValSource, Inc.

  Mr. Frederic B. Ayers is a Sterility Assurance expert with over two decades of experience in the bio-pharmaceutical manufacturing sector. His strategic guidance has left a lasting impact on global networks within the industry. As a trained Six Sigma Greenbelt, Fred has consistently demonstrated his ability to build cross-functional teams, even under high-pressure conditions, without compromising the quality of outcomes. His commitment to open and direct collaboration ensures that all team members have the opportunity to express their views and ideas. With an extensive career in pharmaceutical manufacturing, Fred Ayers currently serves as a Senior Consultant in Microbiology at ValSource, Inc., where he provides consultation services to the pharmaceutical and biopharmaceutical industries. His expertise lies in Contamination Control, Sterility Assurance, and Microbiology, all of which play a critical role in ensuring the quality and safety of pharmaceutical products. He has a proven track record of driving projects that directly impact the lives of patients served by the industry.
• 

  Peter Berzins

  Sr. Director - Global Quality Systems, Eli Lilly

  Read Bio

  

  Peter Berzins

  Eli Lilly

  Peter Berzins is currently a Senior Director – Global Quality Systems for Eli Lilly and Company. He is responsible for external monitoring, establishing, and oversight of Lilly’s Global Quality Standards for Production Practices, Validation, and Sterility Assurance. In addition, he leads Lilly’s Annex 1 Global Team for the external engagement and commenting during the draft commenting periods and Lilly’s global implementation of Annex 1 across all Lilly manufacturing.

  Mr. Berzins holds an undergraduate degree in Bio-medical Engineering from Marquette University in Milwaukee WI and an MBA from Meredith College in Raleigh NC. He has over 31 years of operational, engineering, quality, and leadership experience in the US Navy and Pharmaceutical industry, including 25 years of Parenteral and Device manufacturing experience. Mr. Berzins’ roles have included project and technical leadership of several parenteral manufacturing facility design, construction, commissioning and qualification, start up and regulatory approval projects. In addition, he has supported and led several parenteral and device manufacturing operations. Finally, he has implemented several education, training, qualification and career progression programs in engineering, quality, and operational roles. Mr Berzins has been a PDA member for nearly 25 years and is active in various interest groups including Annex 1 Implementation, Facilities and Engineering, Filtration, and Sterile Processing / Parenteral Drug Manufacturing.

• 

  Jose Caraballo-Oramas

  VP Quality Systems, Compliance, and Quality Engineering Corporate Quality, Kite Pharma

  Read Bio

  

  Jose Caraballo-Oramas

  Kite Pharma

  Jose Caraballo is a Biotech/biopharma executive with extensive quality, development, and manufacturing expertise. As VP of Corporate Quality, he directs and oversees global compliance, global quality systems, and global quality engineering functions for Kite Pharma, a Gilead company. Previous roles include Head of Corporate Quality Audit and Inspections for the Americas, Quality Lead for Bayer’s Cell Culture Technology Center, and Global Product Quality Lead. In addition, he is experienced in Process Optimization, Manufacturing Operations, Technology Transfers, Facility Start-ups, GxP Compliance, and Regulatory Submissions from multiple roles in development, quality, and manufacturing at Bayer, Amgen, and Abbott Laboratories.

  He currently serves as a member of the PDA Advanced Therapy Medicinal Products Advisory Board (ATMP AB), member of the PDA Biopharmaceutical Advisory Board (BioAB), a member of the Editorial Board of the PDA Journal of Pharmaceutical Science and Technology, and a member of the ISPE Guidance Documents Committee (GDC). He holds ASQ CQA, CQE, and CQM/OE certifications and has authored ISPE Guides on Cleaning Validation, Technology Transfer, and Autologous Cell Therapies.

  Jose holds Master's and Bachelor's degrees in Chemical Engineering from the University of Puerto Rico and an MBA from the University of Phoenix.

• 

  Farah Fawaz

  VP, CMC Quality, Allogene Therapeutics

  Read Bio

  

  Farah Fawaz

  Allogene Therapeutics

  Farah Fawaz received her Ph.D. in cellular and Molecular Biology from the University of Michigan in Ann Arbor working on antibiotic production in Gram positive bacteria, and completed her post-doctoral work at the University of California San Francisco on bacterial pathogenesis and host cell signal transduction. Farah's first job was at Onyx Pharmaceuticals where she worked in the Research assay development group on oncolytic viruses. She then moved to the Development team at Berlex/Schering AG where she worked on assay development for gene therapy and allogeneic cell therapy products.

  Following 6 years at Berlex, Farah joined Bayer, again in the development group where she headed the Analytical Development/Biochemistry team. She also had the opportunity to be the CMC lead for four programs while heading the Biochemistry laboratory, two of which made it to approval. After another 6 years in development, Farah moved to the product supply organization within Bayer where she headed the commercial QC Analytical Chemistry organization. From Bayer, she moved to Intarcia Therapeutics to build their commercial QC organization.

  Farah then moved to Allogene as head of QC where she built the QC organization and supported the advancement of the various clinical programs. More recently, her role has been expanded to encompass external quality assurance activities and grow a team of Product Quality Leads (PQL) in addition to QC.

• 

  Joe Jerkins

  Senior Director, Chapter - Lead, Drug Substance Make, Assess, Release, Genentech

  Read Bio

  

  Joe Jerkins

  Genentech

  Joe Jerkins is Senior Director, Chapter - Lead, Drug Substance Make, Assess, Release at Genentech in South San Francisco. His team is accountable for oversight of Make, Assess, and Release (MAR) clinical and commercial products, inclusive of Large Molecule GMP cell banks, Large Molecule GMP drug substance, and Small Molecule GMP API. His team is also accountable for Quality membership on early stage clinical development (CMC) projects (QSPOC) and disposition of clinical trial material from cell bank through final label pack.

  Joe recently completed a four-year rotation as quality lead for the design, build, commission, qualification and start up of the SSF Clinical Supply Center (CSC). The CSC is an agile small volume modular biologics manufacturing facility that leverages new technologies and digital solutions to rapidly and sustainably bring new medical advances to patients. It was recognized by ISPE as the 2023 Pharma 4.0 category winner as well as for overall Facility of the Year (FOYA).

  Joe previously held leadership positions in Global Quality Systems, IMP Quality Assurance, Biochem Operational Excellence, cell culture, fermentation & media prep production operations.

• 

  Nicolás Maldonado

  Executive Director, Global Quality Systems & Compliance, Gilead

  Read Bio

  Nicolás Maldonado

  Gilead

  Nicolás is an executive leader and change agent with 34 years of global, well-rounded experience in the Immunodiagnostics, Biopharmaceutical & Medical Device businesses. He holds an outstanding record for driving successful compliance, operational excellence, and personnel development, and has led multiple large-scale projects to grow businesses and organizational capacity. Before joining Gilead, Nicolás completed 27 years in Abbott Laboratories where he held positions of expanded leadership in Technical Support, Analytical Laboratory Operations, Regulatory Compliance, Quality Assurance Operations and Quality Systems in Puerto Rico, the continental US and in Europe, Northwest Africa and Russia. At Gilead Sciences, Nicolás has been spearheading the Quality digital strategy, including advancing the implementations of Veeva Vault Quality Docs, QMS and RIM across Gilead and Kite. He is complementing these by driving a global strategy for Advanced Analytics, Data Visualization, Technology Adoption Tools and modernizing the employee learning experience. Nicolás holds a BS degree in Biochemistry from Stony Brook University, and a Masters Degree in Microbiology & Immunology from the Medical School at Temple University, where he completed research work in protein biochemistry and in the immunoregulation of autoimmune diseases.
• 

  April Muir

  Director, Data Integrity, Thermo Fisher

  Read Bio

  

  April Muir

  Thermo Fisher

  April Muir is a Quality Assurance Director, leading the Global Data Integrity Program at Thermo Fisher Scientific, Pharma Services Group (PSG). In this role, she is responsible for implementation and management of the Data Integrity program for more than 60 sites across 24 countries, for CDMOs including for small molecule, large molecule, advance therapies, and clinical trials. She has over 21 years of progressive professional experience in management, Quality Assurance and Analytical Development. A graduate of University of North Carolina at Greensboro, April holds a Bachelor of Science in Biology and a Masters in Biochemistry.
• 

  Parita Raval

  Director, Quality Assurance / Compliance Vendor Management, Ionis Pharmaceuticals, Inc.

  Read Bio

  

  Parita Raval

  Ionis Pharmaceuticals, Inc.

  Passion for change! Change can be intimidating but that’s what excites and intrigues Parita everyday. Constantly challenging status quo, being innovative and making change, Parita enjoys building successful processes/systems and motivated teams while keeping compliance at the forefront. As Director of QA & Compliance Vendor Management at Ionis Pharmaceuticals, Inc., she is empowered as a Bio Pharma Quality Leader to drive change and comes to us with 25 years of experience in GMP Clinical & Commercial manufacturing.
• 

  Susan J. Schniepp

  Distinguished Fellow, Regulatory Compliance Associates Inc.

  Read Bio

  

  Susan J. Schniepp

  Regulatory Compliance Associates Inc.

  Susan Schniepp has over 40 years of quality assurance experience in the pharmaceutical industry. She has earned several awards from the PDA, including Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award. Sue’s publications include the book, Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, for which she was awarded the 2007 PDA’s Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers. Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011- 2013 and from 2016- 2019 and is currently the Chair of the BoD (2022 - 2024). Sue has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a technical report relating to manufacturing data integrity issues and participating in PDA’s standard setting activity regarding purchasing controls. Sue is also an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm International Magazines. She holds a bachelor of science degree in Microbiology from Northern Illinois University.
• 

  Kristie Taber

  Sr Director, Quality, Gilead

• 

  Sheba S. Zaman

  Head of Product Specialists and Training Services, Novatek International

  Read Bio

  

  Sheba S. Zaman

  Novatek International

  Sheba Zaman has been serving in a technical role at Novatek International for over 20 years. With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems such as Contamination Control, Environmental and Utility Monitoring, Cleaning Validation, LIMS, Stability and Quality Management 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 managing change and implementation of software solutions, including process mapping, establishing procedures, work instructions, validation scripts and training programs. Key areas of expertise include Data Integrity, Process Improvement, Data Analysis/Trending, regulatory compliance, software Implementation and optimization in a regulated environment. She also teaches PDA tri/ISPE/KENX courses for various contamination control topics and formerly served as the President of Parenteral Drug Association’s (PDA) Southern California Chapter.