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Committee & Speaker Biographies

Committee & Speaker Biographies

2021 PDA Remote Audits and Inspection Workshop

08 April 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",

  • Bob Dana

    Robert L. Dana

    Elkhorn Associates Inc.

    Robert Dana is the President of Elkhorn Associates Inc., a firm providing quality and regulatory compliance consulting services to the health care industry. He has been associated with the pharmaceutical industry for over 50 years. He joined Bristol Laboratories in 1967 as a Research Scientist and was subsequently named Manager, Product Development for their Animal Health Care Products Division.

    He joined the Bristol Myers Squibb Corporate Staff in 1984 as a GMP auditor and progressed through a series of responsibilities, retiring from BMS as Senior Director, Corporate Compliance Assurance; where he led a department responsible for providing GCP, GLP, GMP, Animal Welfare and Controlled Substance auditing and compliance support services to BMS operations worldwide.

    He joined the staff of PDA as Vice President, Quality and Regulatory Affairs in 2005, was named Senior Vice President, Regulatory Affairs and Training and Research Institute in 2009 and Senior Vice President, Education in 2013. He retired from PDA in December 2015.

    Mr. Dana holds a B.S. degree (Pharmacy) from the University of Connecticut. He is a former Director of PDA and the University of Connecticut Pharmacy School Alumni Association and is currently an emeritus member of the University of Connecticut Pharmacy School Advisory Board.

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    Alexandre Drapier

    GlaxoSmithKline

    With more than 15 years experience in the pharmaceutical industry, I've worked in different positions in Quality, from working on the shop floor and managing quality issues up to managing a team in charge of release of drug substances batches. I was also in charge of the different quality aspects associated to the product, e.g., product quality review, recall, audits, change controls, etc.

    After that I moved to a global position to work on alignment of the company with regulatory requirements.

    Currently, I'm working in a global position to, among other tasks, support the Health Authorities inspections in the different manufacturing sites within my company network.

  • Raghuram Pannala

    Raghu Ram Pannala, PhD

    Sciegen Pharmaceuticals Inc

    Dr. Raghu Ram Pannala holds a Ph.D in Analytical Chemistry from Sri Krishnadevaraya University , India and has about twenty seven years of experience in the pharmaceutical industry in the areas of Analytical, Quality and Regulatory Compliance.

    He holds distinctions as a CQA (Certified Quality Auditor) and CMQ/OE (Certified manager for Organizational Excellence) from ASQ and Diploma in SQC from Indian Statistical institute.

    Dr Pannala is also a member of IPC (Indian Pharmacopeial Commission) and USP 2005-2010 monographs acquisition committee. Dr. Pannala has published 20 research publications during his career.

    He is associated with PDA from 2015. He is a part of TR 80 Data Integrity Management System for Pharmaceutical Laboratories and a part of Remote Audits & Inspections Task Force.

    He is associated with Sciegen Pharmaceuticals Inc as Head CQC , RA & PV.

  • 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.

  • Karin Baer

    Karin Baer

    Consultant

    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 as VP Quality-Regional Manager and for Boehringer Ingelheim as Head of Global Quality Assurance 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 in Germany.

  • Tiffany Baker

    Tiffany Baker, MBA

    Concordia ValSource LLC

    Tiffany Baker is a quality risk management and microbiology consultant with Concordia ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiffany is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training and Research Institute, and a Trainer for the PDA training 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.

  • 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.
  • 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.

  • Raghava Mukkamala

    Raghava Mukkamala, PhD

    Centre for Business Data Analytics and Copenhagen Business School

    Raghava Mukkamala is the director of the Centre for Business Data Analytics (https://cbsbda.github.io/), an associate professor at the Department of Digitalization, Copenhagen Business School. He is also the Study Line Coordinator for the new Masters Programme in Data Science (Cand.merc. (IT) – Data Science).

    Raghava’s current research focus is on the interdisciplinary approach to big data analytics. Combining formal/mathematical modeling approaches with data/text mining techniques and machine learning methodologies, his current research program seeks to develop new algorithms and techniques for big data analytics such as Social Set Analytics.

    In addition to the development and management of the new Masters Programme in Data Science, he is also teaching several courses in the areas of programming, machine learning and blockchain technology.

    Raghava holds a Ph.D. degree in Computer Science and an M.Sc degree in Information Technology, both from IT University of Copenhagen, Denmark and a Bachelor of Technology degree from Jawaharlal Nehru Technological University, India. Before moving to research, Raghava has many years of programming and IT development experience from the Danish IT industry.

  • 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.

  • Raghuram Pannala

    Raghu Ram Pannala, PhD

    Sciegen Pharmaceuticals Inc

    Dr. Raghu Ram Pannala holds a Ph.D in Analytical Chemistry from Sri Krishnadevaraya University , India and has about twenty seven years of experience in the pharmaceutical industry in the areas of Analytical, Quality and Regulatory Compliance.

    He holds distinctions as a CQA (Certified Quality Auditor) and CMQ/OE (Certified manager for Organizational Excellence) from ASQ and Diploma in SQC from Indian Statistical institute.

    Dr Pannala is also a member of IPC (Indian Pharmacopeial Commission) and USP 2005-2010 monographs acquisition committee. Dr. Pannala has published 20 research publications during his career.

    He is associated with PDA from 2015. He is a part of TR 80 Data Integrity Management System for Pharmaceutical Laboratories and a part of Remote Audits & Inspections Task Force.

    He is associated with Sciegen Pharmaceuticals Inc as Head CQC , RA & PV.

  • 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.

  • 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",