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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA Data Integrity Workshop

15-16 September 2022

  • Kir Henrici

    Kir F. Henrici

    The Henrici Group

    Kir Henrici has extensive industry experience serving as a quality and compliance consultant with special expertise in the area of Data Governance + Data Integrity, IT and Enterprise Data Management, leading global and site level data governance programs to include designing and executing protocol driven DI assessments, risk analysis, remediation plans and process improvements throughout the organization to ensure a holistic integration of DI principles and controls. She has gained global and diverse perspective and working knowledge of quality, compliance and technical challenges and solutions impacting companies around the world; supporting a range of initiatives including global data organizational area quality system audits and assessments; complex risk management and remediation plans; technical reviews of GMP electronic and manual data related to manufacturing and laboratories; and the enterprise harmonization of policies and procedures.

    Special achievements include the development and execution of product risk assessments driving the successful release of international drug product batches; the complex remediation for a generic drug company in receipt of a 483 and Untitled Letter which resulted in an NAI outcome for the subsequent FDA inspection; and Pre-Approval Inspection Readiness for a domestic biotech company and a medical device company, both of which yielded product approvals.

  • Sandra Boyd

    Sandra A. Boyd

    U.S. FDA
    Sandra A Boyd is a Program Expert, Drug Specialist in the Pharmaceutical Quality Program Branch. Sandy has been with the FDA for 12 years with a focus in the area of drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy. Prior to becoming a Program Expert, Sandy spent her time performing complex drug inspections, including 4 years on the Dedicated Foreign Cadre, training other CSOs, and lecturing in both academic and agency forums. Prior to joining FDA, Sandy was the Director of Quality Systems and a Certified Quality Auditor for an API manufacturer and has worked in the pharmaceutical industry for 18 years. She received her BS degree from the University of Eau Claire.
  • Meg Gallwitz

    Meg Gallwitz

    JAG Healthcare Consulting, LLC

    Meg Gallwitz is a quality and compliance leader with over 30 years’ experience. Meg began her career in parenteral products with roles in QC, Quality, and Audits and Compliance. As an industry consultant, she has developed specialized expertise in Data Governance and data integrity.

    Meg excels in the development and implementation of quality systems that meet compliance requirements yet are achievable and sustainable for her client’s organizations. She has developed and executed a global quality plan for a multi-site global supplier of excipients and API’s and assisted a foreign manufacturer with the development of a QMS to support the manufacture of a cannabis product for clinical study. She has managed and executed the external audit program for a virtual pharmaceutical company headquartered in the US, a role that involved interacting with senior leadership to assess and resolve high-risk compliance issues. Most recently Meg has assisted both US and foreign manufacturers in the execution of internal data integrity and manufacturing investigations as well as developed and delivered site wide training on cGMPs and Data Integrity.

    Meg holds a bachelor’s degree in Chemistry from Rutgers University and is an ASQ Certified Quality Auditor and Certified Pharmaceutical GMP Professional.

  • Ulrich Kollisch

    Ulrich Köllisch, PhD

    GxP-CC
    Dr. Ulrich Koellisch has been on the forefront of the data integrity initiatives and in his previous 6 years has supported many organizations in the pharmaceutical and biotech sector executing Data Integrity campaigns. Ulrich has experience in consulting for audit preparation and conduction in the GMP and the GCP area, is co-heading a PDA special interest group and is an active participant in other industry knowledge groups.
  • Julie Maurhoff

    Julie C. Maurhoff

    Ultragenyx
    Julie Maurhoff is the VP of GxP Compliance and Inspection Management at Ultragenyx. As a Quality professional she has held roles in Pharma, Medical Device, Food and GLP industries. In her current role she built and oversees the GxP Compliance audit program, manages Inspections and Inspection Readiness internally and externally, and was responsible for introducing the expansion of Data Integrity Governance concepts. She is particularly interested in the human side of Data Integrity, exploring the connection between Mindfulness, decision making, and Data Integrity. She has over 25 years of pharma experience and holds a Bachelor’s Degree in Chemistry from University of California, Davis.
  • Bethany Rexing

    Bethany B. Rexing, MS

    Eli Lilly and Company

    Bethany Rexing graduated from Case Western Reserve University with a BS and MS in Chemical Engineering in 2003. Bethany joined Eli Lilly in Analytical Sciences Research and Development in 2004 to support manufacturing investigations in the Surface Science Lab, transitioning to the Forensics lab team leader which included additional analytical instrumentation for manufacturing support.

    Bethany took a role as a TSMS representative supporting an API manufacturing site and spent 6 years in both individual contributor and management roles in the API network. She developed a passion for data, process monitoring and control strategies. She represented Lilly externally at the ISPE Process Validation conference in 2017 to share an applied approach to OPV in an API facility.

    Bethany moved to a Parenteral site as a TSMS Director with accountability for primary packaging components, annual product reports and day to day production. Bethany championed the use of data for decision making and has built and mentors others on how to use visualization tools like Power BI and Tableau.

    In 2021, Bethany moved to Lilly’s Global Quality organization to establish a new M&Q Data Management team. Her team has responsibility for establishment of data standards, business processes and governance for the M&Q organizations.

  • Jennifer Rheaume

    Jennifer M. Rheaume, MBA

    AstraZeneca
    Jennifer Rheaume is passionate about using technology to improve the quality of life for people around the planet. She is a Principal Validation Engineer with over 12 years' experience in validation and process engineering. She has extensive experience in Risk Management as the former Site Representative, and is currently the Data Integrity Representative for Development Quality Biologics with AstraZeneca. She is a PDA member and has a history with the Society Of Women Engineers in leading and participating in outreach events and organizations.
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    Victor R. Gaines

    U.S. FDA
    Ray Gaines is the Branch Chief of Global Compliance Branch 3 in CDER’s Office of Compliance, Office of Manufacturing Quality, Division of Drug Quality I. He has a background in chemistry and over 27 years’ experience between industry and FDA. He started his career as a chemist in a global pharmaceutical company in an R&D lab and moved to plant quality compliance and later managed global contract manufacturers. He was involved with due diligence audits, new business development, and quality and compliance activities. Ray joined FDA in 2011 as an Interdisciplinary Scientist and has also served as a Team Leader. As Branch Chief he oversees the review of violative (OAI) facility inspection reports. Ray holds BS degrees in Chemistry and Biology from Virginia Commonwealth University.
  • Toni Manzano

    Toni Manzano

    Aizon

    Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the Biomanufacturing IG and co-chair of the CPV of the Future initiative at the PDA, Lead of the AI in Operations team for the AI Xavier University and he teaches AI subjects at the Universities (UAB and OBS), member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and collaborator with the UN in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.

  • Ndidi Rickert

    Ndidi Rickert

    Ultragenyx

    Ndidi Rickert is an experienced leader with over 24 years of experience in the Pharmaceutical/Biotechnology industries. She has been recognized as a thought leader Data Integrity and Vendor Oversight. After completing her education, Ndidi began her career in the UK. An opportunity sparked her move to the west coast, US, where she is now lives with her husband. Her background in Biotechnology and proficiency in Data Management solidified her proven ability to identify data integrity risks, and problem solve the most complaint path to drug submissions and approvals. Ndidi leads the X2 Women in Biotech Employee Research Group (ERG) at Ultragenyx. She is also one of the founding members of the UltraMosaic ERG for BIPOC employees. In her spare time, she enjoys creative writing. Ndidi intentionally injects laughter and authenticity into everything she does. She is an advocate for kindness, fostering belonging in the workplace, and is a supporter for issues impacting women, children, and those with disabilities.

    Fun fact: Ndidi was born and raised in Sierra Leone and is a descendant of the Creole people (Liberated African slaves who settled in Freetown) from the Americas and the Caribbean.

  • Tara Safakish

    Tara Safakish, BSc

    Ultragenyx

    Tara Safakish is a Software Engineer with over 15 years of experience in different roles such as Software Developer, Software Quality Engineer and Quality Computer System Validation specialist in medical device and biotechnology/pharmaceutical industries. She is also a Certified Medical Device Auditor (CMDA) and Six Sigma Green Belt (CSSGB).

    She started her career as a software developer and after a few years found her passion in software quality engineering field. She worked for several medical device and biotechnology companies in North America including, CryoCath, enLabel Global Services, Sciex, Avalanche Biotechnologies. Presently, Tara is the Associate Director, QA Computer System Validation at Ultragenyx Pharmaceutical Inc. where she has worked for over 5 years.

    The combination of her education and experience as a software quality engineer involved in all aspects of software development life cycle, including risk management, gives her a unique perspective to identify and assess data integrity risks through its life cycle.

    In her free time, Tara enjoys drawing, traveling, and cycling to nearby coffee shops.

    Fun fact: Tara is a passionate painter and an art enthusiast.