Featured Speakers:

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Dr. Willis H. Thomas, PhD, PMP, CPT

Director, Training and Development, Akorn Pharmaceuticals

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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).

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Joe Zec

CSV & Compliance Lead

Shire plc

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Joe is currently Shire Pharmaceutical’s Computer System Validation Lead, R&D. He and his team define and execute software development and validation strategy and policy, and monitor its effectiveness. He has over 35 years of experience in the software industry. Most of his career has been spent in the areas of software testing and software quality assurance. He has worked in many industries, including financial services, semi-conductor test equipment, telecommunications, commercial meteorology, avionics, and life sciences. An award-winning speaker, he has presented and chaired at numerous conferences, both domestically and internationally. He is also a public speaking and debate instructor, a coach for students applying to private preparatory schools and colleges, and a communications consultant for commercial ventures. A native of Massachusetts, Joe received his BA in Economics from Harvard University.


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Dr. David W. Vincent, PhD

CEO

VTI Life Sciences

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David Vincent has over 28 years experience in the health care industry with 24 years in field of validation. He has BS degree in Industrial Microbiology and Mechanical Engineering Technology degree; he has consulted for many companies national and international. Mr. Vincent has expertise in many areas of Quality Assurance, Regulatory Affairs and Validation, including BLA submission preparation, facility and equipment design review, computer system validation, process development and validation, project management, utility and process equipment qualification. He has been involved in the various aspects of bringing many new drug manufacturing facilities on-line, from design concept and engineering, through construction, commissioning, to the qualification/validation, and licensing phases. He has presented many training seminars and written many articles regarding validation topics. He teaches “Validation Program for Pharmaceutical, Biotechnology and Medical Device Industries “RA 776” at San Diego State University (SDSU) for their Regulatory Affairs Master Degree program. Currently, he is the Chief Executive Office (CEO) of Validation Technologies, Inc. a Global Validation and Technical Services Company.


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Natasha Demberg, BSc, MSc

Quality & Compliance

Demberg Pharma Solutions

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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.


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Dr. Pauline McGregor, Ph.D. CChem MRSC

PMcG Consulting

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Pauline has fulfilled a variety of roles in her thirty years in the pharmaceutical industry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. She brings the experience and ability to customize and install the quality systems required to allow new manufacturing and testing companies to operate to GMP regulations and review and improve on current quality systems to allow more efficient operations. She also brings a technical expertise to laboratories which enable her to assist them to develop analytical procedures, validate them and optimize efficiency with regards to laboratory operations and troubleshooting in a QC environment.

She has experience in utilizing her skill set in the UK, Canada, US, Jordan, Brazil and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses.

Pauline is a member of The Royal Society of Chemistry, UK, and is a proud member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and a USP Chemical Medicines expert committee.

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