Distinguished Speakers & Panelists:
Magda Joseph, B. Eng.
Health Canada/Government of Canada
Biography available soon.
Iuliana Mirbauer,
Health Canada/Government of Canada
Biography available soon.
David L. Chesney, MSJ
Principal and General Manager
DL Chesney Consulting, LLC
Former FDA
DAVID L. CHESNEY, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. Previously he served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.
Mr. Chesney has an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law, from Seton Hall University School of Law, a Bachelor's degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute. He serves as a Guest Lecturer for the Maine Regulatory and Ethics Training Center, University of Maine School of Law, and is also active in the Food and Drug Law Institute and RAPS.
Herbert Vail
Quality and Compliance Principal Consultant
PQE Group
Herbert Vail presently serves as Quality and Compliance Principal Consultant at PQE Group providing GxP compliance consulting services to clients in the US and worldwide. Prior to joining the PQE Group, he served as the Sr. Director of Supplier Quality & cGMP Auditing at Shionogi Inc. for 10 years. He has also previously served in a Quality Assurance role at Baxter Healthcare for 10 years.
Herbert’s quality assurance experience includes Auditing, Contract Manufacturing, Supplier Qualification, Investigation and CAPA management, Validation, Quality Management Systems and Sterile manufacturing.
Herbert received his BS degree in Biology from Rowan College of New Jersey and is a current active member of ASQ, SQA and PDA.
Dr. Willis H. Thomas, PhD, PMP, CPT,
Willis H. Thomas, PhD, PMP, CPT has worked for large corporations and academic institutions in the areas of human resources, learning and development, quality assurance, project management, sales and marketing, measurement and evaluation, and operations. He has been in senior management for life sciences companies for the past 15 years. Dr. Thomas is adjunct faculty at the Lake Forest Graduate School of Management (LFGSM.EDU), International Institute for Learning (IIL.COM) and Institute of Validation Technology (IVT). His publications have received global recognition from associations such as the Project Management Institute (PMI) where he received the Cleland Award for “The Basics of Project Evaluation and Lessons Learned.” This book was an 8-year effort that enhanced the framework for the evaluation of projects using the PMBOK® Guide. He has been a featured speaker on an international basis and has received the Apex Publication Excellence Award for implementing useful tools for project management, evaluation and training with the Association for Talent Development (formerly American Society for Training and Development).
Jane Weitzel,
Independent consultant. Educator, Auditor, and volunteer for standard setting organizations.
Jane Weitzel has been working in analytical chemistry for over 40 years for pharmaceutical and mining companies. She is currently a consultant specialising in laboratory management systems, GMP testing, and ISO/IEC 17025. She is an auditor and an educator. Jane has applied Quality Systems and statistical techniques, including the evaluation and use of measurement uncertainty, in a wide variety of technical and scientific businesses. She has obtained the American Society for Quality Certification for both Quality Engineer and Quality Manager.
Jane was elected to the USP Council of Experts as member of the USP Council of Experts and chair of the 2020-2025 General Chapters–Measurement and Data Quality Expert Committee. She was a member of the USP 2015-2020 Statistics Expert Committee and past member of the USP Expert Panel on Method Validation. She has been Director of pharmaceutical Quality Control laboratories. She has experience with many different regulatory environments.
Alan Golden, BS, MS
Principal
Design Quality Consultants, LLC
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.
Laura Sciascia
Associate
Demberg PharmaSolutions
Laura has over 20 years of experience in the life sciences industry in the Quality field. Laura has worked with pharmaceutical products, natural health products, medical devices, as well as cannabis and cosmetics. Laura has worked in large corporations that manufactured products and clinical supplies, such as Merck Frosst and Wyeth-Ayerst. Laura also has extensive experience working with Contract Manufacturing Facilities and is familiar with setting up quality systems to meet the needs of multiple regulatory agency requirements. Laura has recently taken on the role of consultant to the Life Sciences industry, providing support to clients with quality issues, strategy and setting up robust quality systems. She has extensive experience with regulatory inspections, including Health Canada, FDA, ISO 13485 and Niosh. Laura has a degree in Biochemistry
Felipe Dal Belo
Global Strategic Initiatives Director
PQE Group
Mr. Dal Belo holds a PhD in Artificial Intelligence & Data Science applied at Radiopharmaceutical Technologies, a Major in Pharmaceutical Engineering as well as in Biochemistry and a MBA in Business Administration across his 20 years of career in multiple sectors. He brings a solid experience in Digital Governance, Industry 4.0 projects, AI & Analytics, Risk Management & Compliance, Business Intelligence, Operations, Financial and Accounting Auditing, Privacy, QHSE requirements, Government & Regulatory Affairs. Additionally acts as a Board Member at University of Sao Paulo, International MBA Professor and International Speaker on Digital Governance, Industry 4.0 and Business Analytics.
Steven Walfish
President
Statistical Outsourcing Services
Mr. Walfish is Principal Science & Standards Liaison at United States Pharmacopeia (USP) responsible for the Statistics Expert Committee. Prior to this role Mr. Walfish was Principal Statistician at Becton Dickinson in Franklin Lakes, NJ responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish has held roles at GE Healthcare, Human Genome Sciences and Chiron. Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries.
Mr. Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis.
Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
David W. Vincent, B.Sc., MPH, Ph.D.,
CEO
,VTI Life Sciences
Dr. Vincent has over thirty-three (33) years of experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (26) twenty-six years dedicated to the field of validation (commissioning and qualification [C&Q]). Dr. Vincent has B.Sc. degrees in industrial microbiology and a Master of Public Health and Ph.D. He has hands-on experience in many areas of Regulatory Affairs, Quality Assurance, Commissioning/Qualification, and Engineering including regulatory submission preparation, Cleanroom Design Review, Microbiology Laboratory setup and qualification, Cleaning/Process Validation, Project Management, Utility and Process FAT/SAT Commission Plans, and Equipment Qualification implementation. Dr, Vincent is especially strong in the areas of Upstream and Downstream Process Development and Validation and developing and implementing Cleaning Validation, Aseptic Process, and Environmental Monitoring Programs. Most of his career has been in the Biological vaccine industries, but he has also supported the Medical Device, Biopharmaceutical, and Biological industries.
Vincent has spent the last twenty-seven (27) years providing validation and quality consulting services to various national and international companies, including project management and project execution services. Dr. Vincent is an ASTM committee member for Manufacture of Pharmaceutical and Biopharmaceutical Products - E55 (20-07), Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products - E55.06 (20-01), WK74412 - New Standard Critical Airflow Visualization, and WK69826 - Standard Template for Environmental Monitoring Trend Analysis and WK77957 - New Guide for Standard Guide for Cleanroom Gowning.
Dr. Vincent also coauthored the ISPE GUIDE: Cleaning Validation Lifecycle – Applications, Methods & Controls.
He is responsible for managing and supporting many different product launches. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.
Kia Kahhali
Founder and CEO
APS Compliance Consultants Inc.
With over 20 years of experience in the Pharma industry, Kia has accomplished to build himself a unique profile. This was achieved by tying his electronics engineering and software development background to GMP Computer System Validation and Analytical Instrument Qualification and Management.
With the technical knowledge of main CDS solutions in the market, business processes, and successful records of CDS validation, he is actively working as a reliable resource for many companies looking for selection, implementation, and validation of Chromatography Data Systems.
Kimberly Afonso
CEO & Founder
The KA Consulting Group
Kimberly Afonso is the CEO & Founder of a digital marketing agency specializing in personal branding and thought-leadership strategies for B2B CEOs and Founders.
She is also the thought-leadership partner for PQE Group.
Kimberly is originally from the US and currently runs her agency completely remotely from Europe with a global team.
Thomas Carganico
Marketing & Communications Director
PQE Group
Since 2013, Thomas extensively works within the services’ industry across US, UK and Europe and provides a wide experience related to Digital Branding, Marketing & Strategic Communication. He is part of PQE Group since 2017 as Marketing & Communication Director of the company and member of ISPE since 2020, being responsible for the communication area of the Italy Affiliate Committee and member of the Board of Directors for the Emerging Leaders and Students.
Parsa Famili, MSc
President & CEO
Novatek International
Parsa Famili, Is the President and CEO of Novatek International. Prior to joining Novatek, he held senior management positions in quality departments of several North American pharmaceutical companies. He has participated and successfully completed several FDA, EMEA, TGA, and Health Canada audits. He was also an instructor of Chemistry and Biochemistry at Vanier College in Montreal, Quebec Canada. Mr. Famili has published chapters and articles in various industry journals and publications including contributing as an international speaker at industry events such as today’s KENX event!
His latest contribution “User Requirements & Implementation of a Risk-Based, Compliant Stability Management System” in Methods for Stability Testing of Pharmaceuticals (edited by Edited by Bajaj, Sanjay, Singh, Saranjit, 2018). He is also an international speaker for ISPE, PDA, IVT, IPA, KENX, EXPOFARMA among many other global associations.
Judith W. Umlas,
Senior Vice President, Author, Trainer,
International Institute for Learning, Inc.
Judith W. Umlas is Sr. Vice President, author and trainer at International Institute for Learning, Inc. (IIL), a global corporate training company. She wrote the ground-breaking book, The Power of Acknowledgment ©2006, IIL Publishing, New York, which has been credited with changing workplaces and lives by making use of the 7 Principles of Acknowledgment she developed. Her book on Grateful Leadership, Using the Power of Acknowledgment to Engage All Your People and Achieve Superior Results was published by McGraw-Hill Professional in association with IIL in early 2013 and You’re Totally Awesome! The Power of Acknowledgment for Kids was published in late 2013 by IIL Publishing. In 2016 she founded the Center for Grateful Leadership (www.gratefulleadership.com ) whose members from around the world are committed to practicing and implementing the Grateful Leadership initiative in their organizations.
Judith delivers inspiring, motivational and transformational keynote addresses on Grateful Leadership and The Power of Acknowledgment all over the world. She also leads webinars and teaches full day virtual and traditional courses to organizations such as Volvo, the U.S. Army, Prudential, JMP Engineering, the World Bank, Fannie Mae, IBM, AT&T, Google, Amway, the New York Police Department and many others. She has trained over 100,000 people through her leading edge, highly interactive and engaging courses and keynotes – with outstanding and longlasting results.
Grateful Leadership and The Power of Acknowledgment are Judith’s passion and purpose!
Conference Chair:
Natasha Demberg, BSc, MSc
Quality & Compliance
Demberg Pharma Solutions
Natasha Demberg is a Pharmaceutical and Biotechnology Quality and BD Executive with 25+ years in the development and application of Quality Management Systems throughout the product life-cycle (development, scale-up, and commercialization) and Business Development for Pharmaceutical service providers. She is experienced in leading multi-functional groups to address challenging global regulatory compliance issues, develop strategy for Quality and Business Development, and create company culture oriented to Quality and Customer needs. Mrs. Demberg has audit expertise that spans cGMP compliance, mock-FDA and HC inspections, PAI readiness, and suppliers and vendors audits and qualification. As a BD executive Mrs. Demberg has an expertise of creating the client oriented company culture, efficient customer support and service, and Business Development and sales.
Currently, Mrs. Demberg is providing Quality & Compliance, consulting services for Pharmaceutical and Biotechnology firms. In addition to Quality & Compliance, Mrs. Demberg provides Business Development support to the service companies in Life Science industry.
She is known for her dynamic leadership style and her ability to think strategically. She brings with her the tremendous mix of both technical expertise and regulatory knowledge.
Natasha’s career has included a wide range of successful leadership positions in Quality Organisations of several large companies in the pharmaceutical field. Initially as a chemist at Plantex Teva and Abbott Laboratory and later as Senior GMP Compliance Associate at Merck Frosst Canada, responsible for Quality aspect of Clinical manufacturing, Head of Quality at Valeant Canada and Confab Laboratory responsible of entire Quality Operations, and Vice President Pharmaceutical Solution at Neopharm Labs.
Mrs. Demberg holds a BSc in Chemical Engineering and a MSc in Chemistry of Polymers and is a member of the Quebec Chapter of the Society of Chemists, L’Ordre des chimistes du Québec.
Exhibitors & Sponsors:
