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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Data Integrity Workshop

September 18-19, 2019, Washington, DC

  • Carmelo Rosa, BS, MS, PsyD

    FDA

    Carmelo Rosa has a B.S., M.S., Psy.D. He started with the FDA in May 1990 as an Investigator for the Los Angeles District. Dr. Rosa later transferred to the San Juan District, where for 13 years he served as a pharmaceutical drug Investigator and 6 years as a Compliance Officer. He is member of the foreign drug inspection cadre. He has conducted many inspections of complex pharmaceutical inspections and other commodities regulated by the FDA that have resulted in significant regulatory actions initiated by the FDA. In August 2008 relocated to Maryland to work for CDER as Compliance Officer. In 2009 he was promoted to Team Leader at CDER/DMPQ/OC/ICB, and then to Branch Chief for the International Compliance Branch. He currently serves as the Director for the Division of International Drug Quality I. Dr. Rosa is one of the FDA officials responsible for the review of non-compliant inspections (domestic and foreign), and is involved in FDA’s decision to initiate an enforcement action against pharmaceutical manufacturing and testing facilities that fail to comply with CGMPs. Dr. Rosa has served as an invited Professor at the University of Puerto Rico, School of Law, where he teaches a course on Federal Regulations Enforced by FDA and a General Overview to the FD&C Act. He works very closely with International Regulatory Authorities in different collaboration initiatives. Dr. Rosa is the former Chair for the PIC/S API Expert Circle.

  • Jacqueline Veivia-Panter

    Jackie Veivia-Panter

    Legend Biotech

    Jackie has many years of experience within pharmaceutical quality across the product life cycle. Her experience includes site head quality, R&D quality lead and corporate/divisional quality roles within quality systems. She has worked at large and small pharmaceutical companies including Pfizer, Abbott/Abbvie and Celgene.  She led the global Data Integrity team at Celgene developing and implementing DI policies, procedures and training. Her current role is with Legend Biotech leading Global Quality Systems and Compliance.  In addition, Jackie is the Chair of the Regulatory Affairs and Quality Advisory Board (RAQAB) at PDA and leads the Data Integrity Interest Group. She was also involved in the Data Integrity Q&A document on inspections and is currently involved in the Technical Report for Data Integrity in Quality Management Systems.

  • Monica Cahilly

    Monica Cahilly

    Green Mountain Quality Assurance LLC

    Monica Cahilly, President, Green Mountain Quality Assurance LLC has been consulting nationally and internationally for 25+ years, with specialized interest in Data Integrity Assurance. Monica was invited in February 2009 by U.S. FDA to present to CDER Offices of Compliance the topic of ‘Detecting Aberrant GxP Data and Handling Practices’ and has subsequently been invited to provide on-going training in the topic of Data Integrity Investigations to U.S. FDA as well as to the World Health Organization (WHO), the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Irish Health Products Regulatory Agency (HPRA), Health Canada (HC), the European Medicines Agency (EMA), the Italian Medicines Agency (AIFA), China Food and Drug Administration (now China NMPA), Swissmedic, Pharmaceutical Inspection Co-operation Scheme (PIC/S), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Australian Therapeutic Goods Administration (TGA), and others. Monica’s most recent interests include working in healthcare policy to prevent and detect data integrity issues as these relate to safe, effective, and cost-effective medicines. Monica has a bachelor’s degree in Biochemistry from Dartmouth College, a master’s degree in Genetic Toxicology from M.I.T., is a member of PDA, DIA, ISPE, and SQA.

  • Kir Henrici

    Kir Henrici

    The Henrici Group

    Kir Henrici is the CEO of the Henrici group; a boutique consultancy providing strategic quality and compliance solutions to FDA regulated drug, biotech, and medical device innovators around the world.  She has a special interest in data integrity and the science of data analytics in the emerging next generation of big data, IoT, smart manufacturing and Artificial Intelligence.

    Kir Henrici has extensive industry experience serving in executive and consulting roles for Nutraceutical, Pharmaceutical, Biotech and Medical Device industries, to include managing and supporting FDA inspections, communications and remediation for companies in receipt of 483’s, Warning Letters, Untitled Letters, and Import Alerts.  She has gained global and diverse exposure, perspective and working knowledge of quality, compliance and technical projects and solutions impacting companies around the world; supporting a range of initiatives including Pre-Approval readiness, organizational/functional area/quality system audits and assessments, complex risk management and remediation, technical reviews of GMP electronic/manual data related to manufacturing and laboratories, and enterprise harmonization of policies and procedures.

    Ms. Henrici has a special focus on Data Integrity, 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 developed and delivered training modules for Data Integrity to meet basic and advanced training requirements that include level one, annual refreshers, and advanced DI training for auditors.  Additional core expertise includes Deviation/Investigation Management and Root Cause Analysis, CAPA, Change Control, Risk Management and Validation.

    Ms. Henrici has a strong knowledge base of sterile processing/aseptic practices, oral solid manufacturing, continuous manufacturing/Process Analytical Technology (PAT), Quality by Design (QBD), IT and computerized systems and integrations.

    Ms. Henrici is also a author/co-author and contributor for presentation(s) and training modules for key industry forums to include PDA/FDA Joint Regulatory Conference, PCCIG, IQPC and PICs.  She serves as a Co-Lead for the PDA Task Force team responsible for the Data Integrity in the Quality Management System technical report, and a team member for the DI in Manufacturing technical report.  She also serves on the Steering Committee for the PDA Data Integrity Workshop scheduled for fall 2019, and was a contributor to the PDA/DHI Book: Assuring Data Integrity for Life Sciences.

  • Amanda Bishop McFarland

    Amanda M. McFarland, MS

    ValSource LLC

    Amanda McFarland is a Senior Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate a global risk management program by developing the procedures required and training the organization in the execution of consistent risk management tools.

    Ms. McFarland currently serves as the PDA QRM Interest Group co-lead, the PDA SE Chapter Secretary and is a faculty member of the Quality Risk Management Certificate Training Series at PDA Training Institute.

  • Ronald Tetzlaff

    Ronald F. Tetzlaff, PhD

    PAREXEL International

    Dr. Tetzlaff is currently Corporate Vice President, PAREXEL International LLC. His 50+ years of experience includes 27 years as an Investigator with the FDA, and during the past 25 years with PAREXEL he has provided GMP compliance and quality system services to companies located throughout the world. He received B.A. in Zoology from the University of Washington, Seattle and M.S. and Doctor of Philosophy degrees in Pharmaceutics from the University of Georgia, Athens. Dr. Tetzlaff is a member of PDA and FDLI, and is active in industry programs on quality management, GMP compliance, and data integrity related issues, having made more than 300 presentations at various national/international industry symposia and FDA training programs, and he has published more than two dozen articles and several chapters in textbooks. He is currently a steering committee member of PDA Task Force on Data Integrity, and for past 20+ years has served a member of the Conference Advisory Committee for the UGA International GMP Conference.

  • Peter Baker

    Peter E. Baker, MS

    Green Mountain Quality Assurance and formerly with the FDA

    Peter E. Baker spent 11 years as an FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile.  Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity, and has special interest in big data management and compliance with 21 CFR Part 11. He speaks Chinese (Mandarin) and Spanish, and has performed more than 100 foreign drug inspections around the world on behalf of the FDA. His inspection experience includes performing six systems manufacturing inspections of API’s, intermediates, and finished dosage, including complex small and large molecules.

    Peter holds a Bachelor of Science (B.S) degree in Biology-Chemistry from Point Loma Nazarene University, a Masters of Science (M.S.) in Chemistry from San Francisco State University, and is an active member of PDA, DIA, and ISPE.

  • Cylia Chen-Ooi

    Cylia Chen-Ooi, MS

    Amgen Inc.

    Cylia develops the external engagement strategies for Amgen and is actively engaged with several industry associations such as PhRMA, BIO, PDA, RX-360, ISPE, and others. She is currently the co-leader of PDA Quality Metrics/Culture Task Force Team and have led a panel of experts from industry to develop quality culture assessment tool to help industry advance understanding and maturity of quality culture at their companies. Prior to her current role, she led several initiatives for Amgen’s international expansion in Asia region and she has extensive experience in fill finish process development. She holds a Master’s degree in Regulatory Science and B.S. degree in Biomedical Engineering from University of Southern California.

  • David Churchward

    David M. Churchward, MSc

    MHRA, UK

    David Churchward has been a GMP inspector with the UK MHRA since 2004 and is responsible for the strategic direction of the GxP inspectorate.

    He has extensive involvement in international regulatory harmonisation and collaboration through the PIC/S sub-committees for Strategic Development (deputy chair) and GMP Harmonisation. He is also PIC/S delegate to the ICH Assembly and MHRA’s representative at the EMA GMP/GDP Inspectors Working Group.

    David is co-chair of the PIC/S data integrity working group. He led the MHRA’s GxP data integrity expert group from 2013 to 2017, was rapporteur for the 2016 EMA data integrity guidance, and part of the drafting team for the 2016 WHO guidance on good data and record management.

  • Tom Cosgrove

    Thomas Cosgrove, JD

    Covington & Burling LLP and formerly with the FDA
  • Mark DiMartino

    Mark A. DiMartino, MS

    Amgen

    Mark DiMartino is currently the Director of Quality Data Sciences at Amgen, Inc. In this role Mark is responsible for the application of Artificial Intelligence (AI) techniques such as natural language processing and machine learning on manufacturing and quality related data with the goal of unlocking insights and improving operations.  Prior to this role, Mark was the Director of Quality Engineering (QE) responsible for statistical support to all Operations’ sites outside of Puerto Rico. In addition to his QE role, Mark also served as the global network lead for the Product and Process Performance Network (PPP) which is charged with developing and improving the Continued Process Verification (CPV) procedures at Amgen and representing Amgen’s position on CPV externally.

    Mark has a BS in Cellular Biology from the University of Illinois Urbana-Champaign and an MS in Applied Statistics from DePaul University.

  • Thomas Friedli

    Thomas Friedli

    University of St. Gallen

    Prof. Dr. Thomas Friedli is a Professor for Production Management at St.Gallen University in Switzerland. His main research interests are in the fields of managing operational excellence, global production management and management of industrial services. He is a lecturer in the (E)MBA programs in St.Gallen, Fribourg, Salzburg, Aachen. He spent several weeks as Adjunct Associate Professor at the Purdue University in West Lafayette, USA. Prof. Friedli leads a team of 15 researchers who develop new management solutions for manufacturing companies in today’s business landscape. In 2007, he became an Associate Member to the International Academy for Quality (IAQ) and joined the SAQ (Swiss Association for Quality and Management Systems) as an advisory council in 2009. Furthermore, he is a member of the HSR Committee of Experts in Machinery/Innovation. Since 2011 he is an Expert at the ‘Österreichischer Akkreditierungsrat’ and as of 2012, he is acting as president of the jury for the REHAU business award. Since 2014, he is an active member of the RUAG Holding Strategic Advisory Board. He also is the editor, author or co-author of 14 books and various articles.

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    Ronald D. Gunn, MS, MBA

    Kaleo, Inc.

    Ron is kaléo‘s Chief Operating Officer. He is responsible for overseeing the manufacturing and supply chain, quality assurance, medical affairs, pharmacovigilance, development and regulatory affairs aspects of kaleo's business. Ron has more than 30 years of pharmaceutical/biotechnology development and operations experience. Prior to joining kaléo in 2008, Ron served as Executive Vice President and Chief Operating Officer for Insmed Incorporated where his responsibilities included R&D, regulatory affairs, finance, manufacturing and quality assurance. Prior to joining Insmed, he held several development and operations positions with domestic and foreign companies within the pharmaceutical industry. Ron received a BS from Radford University and earned an MS in Statistics and an MBA from Virginia Commonwealth University.

  • Julian Macuvele

    Julian Macuvele, MSc

    University of St. Gallen

    Julian Macuvele is a Research Associate at the Institute of Technology Management at the University of St.Gallen, Switzerland. In his research, Julian focuses on Production Management and on driving Operational Excellence and Lean Production with cutting-edge technologies and innovative management approaches. Before starting the phd program at the University of St.Gallen, Julian earned his Master's degree in mechanical engineering at RWTH Aachen University, Germany with a focus on design and development.

  • Julie Maurhoff

    Julie C. Maurhoff, CQA

    Ultragenyx Pharmaceutical

    Julie Maurhoff is a Senior Director of GxP Compliance and Inspection Readiness at Ultragenyx Pharmaceutical.  She is an ASQ Certified Quality Auditor and Quality professional with over 25 years of industry experience spanning Quality Operations in BioPharma, Medical Device, Food and GLP industries, including Technical Recruiting and Talent Placement.  She has spent the past 15 years focused on pharmaceutical GMP Auditing and Regulatory Inspection preparation and execution.  Julie is a mindful meditation practitioner.

  • Amy McLaren

    Amy L. McLaren

    Ultragenyx Pharmaceutical

    Amy McLaren is a Senior Director of Quality and Compliance at Ultragenyx Pharmaceuticals and heads Global Health Authority Inspection Management and Risk Management.  Amy is a seasoned Clinical Research and Quality professional with 23 years of experience in a variety of indications including Neurology, Oncology and Rare Disease.  Throughout her career, she has managed Phase II and pivotal Phase III Clinical Programs and led cross-funtional teams and sites across the globe through the process of Regulatory Agency Inspection.

    Amy’s experience has taught her the importance of both technical expertise and emotional intelligence as it relates to individual and team performance. Being an effective leader in today’s world is complex. Over the course of her career, she has experienced the evolution of the workforce. Today’s talented professionals demand leaders to be engaging and inspiring – while cultivating teams where diverse skill-sets and perspectives are not only welcomed, but leveraged.  Amy brings to her organization an eye for continuous improvement and believes that a balance between structured framework and creativity is necessary for people to do their best work.

    Amy is a 300-Hour Certified Mindfulness Meditation Teacher, holds her Yellow Belt in Kaizen and received her BS from Temple University in Kinesiology. 

  • Els Poff

    Els Poff

    Merck & Co., Inc.

    Els Poff is Executive Director, Data Integrity Center of Excellence.  She is responsible for overseeing the execution of all quality and GMP compliance remediation activities related to data integrity for all Merck manufacturing sites and external partners network.

    Els graduated from the Industrial College of Brussels, Brussels, Belgium where she earned a BS in Industrial Engineering and a Masters of Engineering degree in Mechanical & Industrial Engineering.

    Els is an active member of the PDA Data Integrity Task Force and is currently leading the development of a PDA Technical Report around Data Integrity in Manufacturing.

  • Ervin Rodriguez

    Ervin Rodriguez

    GlaxoSmithKline

    Ervin Rodriguez is currently Vice President, Quality Systems for Pharmaceutical Supply Chain at GSK. Ervin has a Bachelors degree in Psychology from the University of Puerto Rico and a Masters degree in Industrial/Organizational Psychology from the Puerto Rico Institute of Psychology.

    In his current role, he is responsible for Data Integrity, the Quality Digital Solutions team, Computer Validation teams, Manufacturing ERP Quality Programme, Quality Data Analytics, Quality Risk Model, Quality Workflow and Quality Dashboard. He is also responsible for Global Human Performance & Compliance Training.

    Ervin's team is the link between manufacturing Quality and Tech/IT innovation, leading implementations for automated lab systems, documentation systems, predictive risk analytics and electronic batch record systems.

    Ervin has been with GSK for 15 years and has had roles as VP of Human Resources and Site Director of the Cidra plant in Puerto Rico. Before joining GSK, Ervin had leadership roles in a number of fields including Training, Organizational Development, HR, Communications, Public Affairs and Logistics Capability for companies like Intel, Schering Plough and Eli Lilly.

  • Gregory Tewalt

    Gregory L. Tewalt, PhD

    Kaleo, Inc.

    Gregory Tewalt has over 30 years of experience within pharmaceutical, biopharmaceutical, and drug/device combination product organizations worldwide.  He led company and divisional technical and quality strategy to include: developing laboratory and manufacturing system commissioning, qualification and validation practices for clinical and commercial small and large molecules aligned with industry standards and regulations; actualizing initiatives for a new CMO to establish the Quality Management System (QMS), integrating risk management principles to streamline facility and equipment qualification practices; and successfully executing 2011 USFDA Process Validation practices.

    Gregory is the Director of Quality Systems and Compliance at Kaleo, Inc. in Richmond, Virginia, where he manages, implements, and maintains kaléo’s QMS for all GxP operations aligned with applicable regulatory, ICH and ISO guidelines and standards. He develops and implements continuous quality system improvements, has redesigned and implemented a robust risk-based supplier qualification program, manages and conducts internal and supplier audits, and ensures inspection readiness at kaléo and all suppliers.

    Gregory champions data integrity and quality culture programs within the Development and Operations organization at kaléo; hosting the annual kaléo Quality Summit, which fosters transparent and collaborative partnerships with kaléo suppliers utilizing discussion of current regulatory trends and topics, invited speakers, and group participation exercises.

  • Aditi Thakur

    Aditi S. Thakur, MS

    FDA

    Aditi S. Thakur, M.S.  joined the FDA, Office of Process and Facilities in 2015 as a chemist, where she performs pre-approval assessment of submissions and participated on Preapproval Inspections (PAIs).  Prior to the FDA, she worked in two separate cGMP complaint specialty pharmaceuticals companies involving complex soft gelatin and inhalation dosage forms. Aditi earned a M.S. in Industrial Pharmacy from Long Island University. Aditi is currently working as a acting quality assessment lead, and is responsible for primary and secondary review of Process/Facility reviews. Aditi has been involved in various data integrity cases in Agency.  Aditi’s interests include data Integrity evaluation of the submissions, regulatory manufacturing risk assessment, and complex manufacturing processes and dosage forms.