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Committee & Speaker Biographies

Committee & Speaker Biographies

2021 PDA Remote Audits and Inspections Workshop

13-14 September 2021

  • Eva Urban

    Eva M. Urban, MSc

    CSL Behring

    Eva M. Urban is a Quality Professional with 25+ years of experience in various functions –operations and quality- within multi-national biopharmaceutical and biotech industries:

    • Risk Management, Quality Management System, Internal and External Auditing, Change Management, Regulatory
    • Inspections, Global Systems’ Implementations, Quality Operations (Investigations, Change Management, Training, Environmental and Clean Utilities Monitoring, Equipment Cleaning/Cleaning Validation, Compliance)
    • Biotechnology R&D, process transfer and production experience covering fermentation, bio oxidation, strain selection and including project management in aseptic production of biotech cGMP APIs.

    Currently working as Director Quality Risk Management, Global Quality, at CSL Behring.

    Volunteer for PDA: member of RAQAB (Regulatory and Advisory Board), Chair of the working group for the IPEC/PDA Technical Report “Formalized Risk Assessment for Excipients”, Coordinator for the PDA Interest Group Quality Risk Management, Member of Steering "Creative" Committee of PDA Quality System’ Interest Group, Planning Committee Member for PDA Conferences, Co-Chair Task PDA Task Force "Remote Audits and Inspections",

  • Lynne Ensor

    Lynne A. Ensor, PhD

    PAREXEL International
    Dr. Lynne Ensor is the Vice President, RCS Head of Global Compliance, for Parexel International and has been a consultant to the biopharmaceutical industry since 2019. Her areas of expertise include sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, regulatory facility compliance, and regulatory policy development. Prior to consulting, Lynne was employed by the U.S. Food and Drug Administration for 21 years. She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/Office of Pharmaceutical Quality/Center for Drug Evaluation and Research and was responsible for new, generic, biologic and biosimilar drug product quality review and facility assessment. Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the Office of Pharmaceutical Sciences’ New and Generic Drug Product Quality Microbiology staff, and Director of Office of Generic Drugs’ Division of Microbiology. Lynne’s previous experience includes serving as a Clinical Microbiologist at Roche Biomedical Laboratories, a script consultant for the Discovery Channel, and a Post-doctoral Fellow at the University of Maryland at Baltimore’s School of Medicine. She earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.
  • Vishal Sharma

    Vishal Sharma

    Vienni Training & Consulting LLP

    Vishal Sharma is Masters in Microbiology, and is member of the group that provides technical and practical support to the biopharmaceutical industry in India. He has played a hand in helping many organizations grow and change, especially in the oncology research/development, scale-up, production, monitoring and validation. He has a body of credible work in the aseptic process and terminal sterilization optimization, in India. Vishal has been instrumental in providing valuable support to many biopharmaceutical industries in areas of regulatory compliances- from identifications of equipment and process suppliers/vendors to adopting cGXP practices for organizational technical and process capacity building.

    With more than 21 years of being in the biopharmaceutical and allied industry, Vishal is committed to supporting and strengthening the systems approach that has been used in biopharmaceutical organizations especially in the microbiology and aseptic areas, where he helps with optimization, rationalization, change, governance, strategic planning, team building, leadership development, and conflict management.

    Specialties: Vishal has a deep interest in the impact of an organization’s process optimization on its culture, with a particular emphasis on the effects of return on investment in aseptic processing, microbiology & sterilization.

  • Peter Smith

    Peter D. Smith

    Smith GMP Consulting

    Peter Smith formed his own company following retirement from PAREXEL Consulting in April 2018 where he worked for 23+ years in various positions. His last position was Vice President, Technical where he worked with clients in the pharmaceutical and biologics industry worldwide, which continues with his current company.

    Mr. Smith joined PAREXEL in 1994 following a 22-year FDA career. At FDA, he worked in the field and at headquarters as an Investigator, specializing in pharmaceutical GMP/GCP inspections. His last position at FDA was Associate Director, International and Technical Operations Branch, Division of Field Investigations where he managed the FDA’s Foreign Inspection Program.

    Mr. Smith has primary expertise in GMPs for sterile and non-sterile drug dosage forms, active pharmaceutical ingredients, management of inspections, including Pre-approval and foreign inspections, GMP quality systems and FDA regulatory issues. He has experience in antibiotics, radiopharmaceuticals, parenterals, non-clinical (GLP) laboratory studies, and GCP compliance.

    Mr. Smith holds a BS in Biology from Roger Williams University, Bristol, Rhode Island. He is a member of PDA, ISPE and RAPS, and is an Associate Adjunct Professor at the University of Rhode Island, College of Pharmacy, providing lectures to pharmacy students.

  • Karin Baer

    Karin Baer

    Neuroderm- a Mitsubishi Tanabe Pharma Group Company

    Karin Baer has more than 25 years of experience in the Quality field. She holds her Degree in Chemistry and Biochemistry from the Hebrew University, Jerusalem, Israel.

    Karin worked for Teva Pharmaceutical Industries, Pharmaceutical Operations Division in many different positions for many years. In her last role, she was VP Quality-Regional Manager and Head of Global Quality Assurance for BI until 2020.

    Karin is a courageous Quality Leader with lots of broad experience and the ability to motivate people. She was born and grew up in Switzerland, then moved to Israel, and now works for Neuroderm as VP Quality.

  • Tiffany Baker

    Tiffany A. Baker, MBA

    ValSource Inc.
    Tiffany Baker is a quality risk management and microbiology consultant with ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, facilitating risk assessments, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiff is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on quality risk management foundations as well as practical application of QRM tools. She is also co-lead for the PDA task force on Remote Audits and Inspections. Additionally, she was a member of the core team who co-authored the ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College.
  • Ghada N. Haddad, PhD

    Merck & Co., Inc.

    Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree and a PhD and an MBA with over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the Paradigm Change in Manufacturing (PCMO) initiative: QRM in Packaging and Labeling, QRM for the Design, Qualification, and Operation of Manufacturing Systems task forces, co-chaired the Aging Facilities Points to Consider and co-chaired the 2018 and 2019 Annual PDA Conferences and the 2019 PDA Quality Week. She is also a faculty member for PDA’s Training and Research Institute and a Science Advisory Board member and a member of the PDA Board of Directors.

  • Dong Jiangping

    Ms. Dong Jiangping

    Center for Food and Drug Inspection, China Food and Drug Administration
    Ms. DONG Jiangping, Deputy Director-General of CFDI (Center for Food and Drug inspection) of NMPA. Over the past 6 years in this position, she has been responsible for drug inspection (Preapproval and GMP), policy analysis, institutional capacity building and international collaboration related to drug and biologics inspection between NMPA and other regulatory authorities such as FDA, EMA, MHRA, DMA, SI&DGP(Russia). Prior to taking this position at CFDI, Ms. DONG has spent 11 years in the National Institutes of Pharmaceutical Development and Research as the CMC scientist and general manager of R&D, 11 years in CDE as CMC Reviewer and Director of office of Review Operation . Also, she has acted as the Director of the Office of Pharmaceutical Products, Department of Drug & Cosmetic Registration of CFDA for 5 years.
  • Ee Lynn Kok

    Ee Lynn Kok

    Johnson & Johnson

    A highly experienced, driven and credo-based Quality Assurance and Compliance professional. Part of the Johnson & Johnson Enterprise Regulatory Compliance Independent audit team with skill-sets in auditing cGMP, Laboratory systems plus Regulatory Submissions of companies globally.

    • Proven technical expertise include Remote Auditing, Analytical and Microbiology Laboratories, Data Integrity, Quality systems and Regulatory submissions including Labeling
    • Presented at numerous J&J Remote auditing/Labeling workshops plus Data Integrity at ISPE Singapore Conference to a full house.
  • Hemant Koshia

    Hemant G. Koshia, PhD, MPharm

    Food and Drugs Control Administration, INDIA

    Dr. Hemant G. Koshia is working as Commissioner at Food & Drugs Control Administration (FDCA), Gujarat, INDIA since January 2009.

    Diverse experience of 34 years in regulatory affairs working in government and industry. Leading a cross-functional team of 1465 diverse regulatory experts to implement & enforce applicable regulation to regulate 4697 drug manufacturers and 39865 sales units in Gujarat. Playing a pivotal role in transformation of pharmaceutical sector in Gujarat to emerge as a favourable investment destination with proactive & pragmatic approaches.

    He is actively representing in many International, national & state level committees like council of expert (CoE) of United States Pharmacopoeia (USP), Drugs Technical Advisory Board (DTAB), Central Advisory Committee (CAC), Drug Consultative Committee (DCC), etc. Attended maximum number of CAC meetings as compared to others in person.

    Dr. Koshia persuaded his graduation & post-graduation in Pharmaceutical Sciences at L.M. College of Pharmacy, Ahmedabad, Gujarat, INDIA and Ph.D. in Pharmaceutical Sciences from Saurashtra University, Gujarat, INDIA.

    He played a vital role in the implementation of e-governance in the Food & Drugs Control Administration, Gujarat. He has received many Awards & Recognitions from Central Govt., State Govt. & Various professional bodies for e-Governance and Good Governance.

  • Ivy Louis

    Ivy Louis, M.Pharm MBA(HRM)

    Vienni Training & Consulting LLP

    Ivy Louis, Founder of VIENNI TRAINING & CONSULTING LLP with a Master's degree in Pharmaceutical Sciences and an MBA(Human Resource Management).

    32 years of my work experience spans teaching, pharmaceutical manufacturing/quality and service provision. VIENNI Training & Consulting LLP has been involved with consultation (optimizing unit operations for sterile product manufacture), training and educational services from 2010. The areas of support for pharmaceutical and biopharmaceutical operations are in both the core areas of manufacturing, quality assurance & softer elements of human behaviour. Altering approaches to understanding excellence at work with enhancing performance standards is a distinctive feature of our training and consultative services. Having been associated with PDA Inc.(www.pda.org) from 2003, as a member, I have participated in the activities of the PDA Chapter in India, from 2013 onwards. I have held various positions of Chapter Board between 2013-2019 and am the current past President of the Chapter. I have been a Member of the Steering Committee for Awards in 2017, a Member- PDA letter Editorial Committee, a Member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing in addition to being a member of the Science Advisory Board.

  • Iain Moore

    Iain Moore, PhD

    Croda International

    Dr Iain Moore is Croda’s Global Head of Quality Assurance where he has held a range of QA roles since 1995. This included implementing ISO, Excipient and API GMP systems.

    He has contributed to the publication of both European and US National Standards, the famous IPEC-PQG GMP Guide for Pharmaceutical Excipients and the EFfCI GMP Guide for Cosmetic Ingredients. He was instrumental in the team that took the IPEC-PQG GMP Guide and converted it to the EXCiPACT Certification Scheme for Pharmaceutical Excipients.

    He is chair of the EFFCI GMP Committee and is President of the Board of EXCIPACT asbl.

  • Scott Nichols

    Scott R. Nichols, PhD

    Kite Pharma
    Scott Nichols graduated from the University of Iowa with a BS in Biochemistry, continued as a Fulbright Scholar in Microbiology at the Pasteur Institute, and earned a Ph.D. at Johns Hopkins in Molecular Biophysics. He worked as a microbial control and sterility assurance lead reviewer and lead inspector at the FDA for CDER-regulated BLAs. Following this time at the FDA, he worked and as a consultant for regulatory and compliance issues for biotechnology and cell therapy clients; he advised clients on cGMP compliance issues for small molecule nonsterile drugs, biotechnology drug substance, and all forms of sterile drug product manufacture. He advised regulatory clients on submissions of INDs and BLAs for biotechnology products and vaccines. He started in 2020 working as the Senior Compliance Lead at Kite's new CAR-T manufacturing facility in Frederick, Maryland and recently was promoted to the head of Quality Compliance for Kite.
  • Ewan Norton

    Ewan Norton

    Medicines and Healthcare products Regulatory Agency (MHRA)

    Ewan joined the MHRA as a GMP inspector in January 2013. Prior to joining the Agency, he worked in the Pharmaceutical industry for approximately 19 years in positions which included R&D, Scale-up, Process Validation, Outsourcing, Regulatory Affairs and Quality Assurance.

    At the start of the pandemic related travel restrictions in March 2020, Ewan was asked to develop the GMP remote inspection process and then train it out to the other inspectors.

  • Siegfried Schmitt

    Siegfried Schmitt, PhD

    Parexel

    Dr Siegfried Schmitt, VP Technical, at PAREXEL Consulting, joined PAREXEL Consulting in 2007. He provides consulting services to the healthcare industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems. The services cover the entire product lifecycle, from the clinical to the commercial phase, for all aspects of the Good Practices.

    Dr Schmitt’s areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug substances and drug products. Specifically, he consults on compliant quality systems that integrate industry best practices with future-looking compliance approaches.

    He has previously held positions in industry as Senior Production Chemist with Roche and global Quality Director with GE Healthcare and as Validation Manager with Raytheon and Senior Lead Consultant with ABB.

    Dr Schmitt is an active member of various industry associations, the PDA Uk Chapter president, a conference presenter and organiser of international events. He is also an accomplished author and editor.

    Dr Schmitt is a Chemist by background, a Fellow of the Royal Society of Chemistry and he holds Chartered Chemist and Chartered Scientist status.

  • Vishal Sharma

    Vishal Sharma

    Vienni Training & Consulting LLP

    Vishal Sharma is Masters in Microbiology, and is member of the group that provides technical and practical support to the biopharmaceutical industry in India. He has played a hand in helping many organizations grow and change, especially in the oncology research/development, scale-up, production, monitoring and validation. He has a body of credible work in the aseptic process and terminal sterilization optimization, in India. Vishal has been instrumental in providing valuable support to many biopharmaceutical industries in areas of regulatory compliances- from identifications of equipment and process suppliers/vendors to adopting cGXP practices for organizational technical and process capacity building.

    With more than 21 years of being in the biopharmaceutical and allied industry, Vishal is committed to supporting and strengthening the systems approach that has been used in biopharmaceutical organizations especially in the microbiology and aseptic areas, where he helps with optimization, rationalization, change, governance, strategic planning, team building, leadership development, and conflict management.

    Specialties: Vishal has a deep interest in the impact of an organization’s process optimization on its culture, with a particular emphasis on the effects of return on investment in aseptic processing, microbiology & sterilization.

  • Derek Smith

    Derek S. Smith, PhD

    U.S. FDA
    Derek Smith is Deputy Director of the Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality providing leadership of the assessment of the manufacturing process and facilities for biologics and small molecule drug applications with a focus on the integration of application assessment and inspection findings and data reliability assessments. He also serves as the co-chair for FDA's New Inspection Protocol Project (NIPP) initiative for pre-approval inspections and remote assessments. During the COVID-19 pandemic, he has led CDER's efforts on inspection and a key contributor to the utilization of alternatives to inspections. He holds a Ph.D in Chemical and Biochemical Engineering from University of Maryland, Baltimore County.
  • Eva Urban

    Eva M. Urban, MSc

    CSL Behring

    Eva M. Urban is a Quality Professional with 25+ years of experience in various functions –operations and quality- within multi-national biopharmaceutical and biotech industries:

    • Risk Management, Quality Management System, Internal and External Auditing, Change Management, Regulatory
    • Inspections, Global Systems’ Implementations, Quality Operations (Investigations, Change Management, Training, Environmental and Clean Utilities Monitoring, Equipment Cleaning/Cleaning Validation, Compliance)
    • Biotechnology R&D, process transfer and production experience covering fermentation, bio oxidation, strain selection and including project management in aseptic production of biotech cGMP APIs.

    Currently working as Director Quality Risk Management, Global Quality, at CSL Behring.

    Volunteer for PDA: member of RAQAB (Regulatory and Advisory Board), Chair of the working group for the IPEC/PDA Technical Report “Formalized Risk Assessment for Excipients”, Coordinator for the PDA Interest Group Quality Risk Management, Member of Steering "Creative" Committee of PDA Quality System’ Interest Group, Planning Committee Member for PDA Conferences, Co-Chair Task PDA Task Force "Remote Audits and Inspections",