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41

Philip Jarvis

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Director Integrated C&Q and Paperless Strategy, Veqtor Solutions

Mr. Jarvis is an experienced team leader with over 20 years of experience in all areas of validation including; process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation. Through strategic thinking, he has success in steering and managing complex validation projects within the medical device / pharmaceutical / and biologics industries.

42

Kim Huynh-Ba

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Managing Director, Pharmalytik

Kim Huynh-Ba is the Managing Director of Pharmalytik, LLC, a consulting and training organization. She has over 30-years of experience in Validation, Audits, Data Integrity, Quality Systems, CMC, Analytical Lifecycle, and Stability Sciences. She is a Council of Experts of US Pharmacopeia (2015-2025), where she chairs the Small Molecules IV Expert Committee. She is also a member of the USP Drug-Device Combination Products Sub-Committee. Kim is a former President and Distinguished Board Member of the Eastern Analytical Symposium (EAS). She is chairing the American Association of Pharmaceutical Scientists (AAPS) career committee and was named Fellow since 2020. Kim has served on various editorial boards such as AAPS Open and Pharmaceutical Chemistry Journal. Her extensive experience and involvement in various aspects of the pharmaceutical industry highlights her commitment to advance quality standards and best practices in the field.

43

Connie Hetzler

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Global Head Of Validation, Alcon Laboratories

Ms. Hetzler has over 32 years of experience working in regulated consumer products and healthcare industry roles. In her current role as Global Head of Validation for Alcon, she is accountable for the validation strategy for 16 manufacturing sites including both the surgical and vision care divisions.

44

Danielle Duran

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Senior Manager, Training And Development, Site Bus, BioMarin Pharmaceutical

Danielle has worked in learning and continuous improvement program management in biotechnology, tech-startups, k-16 education, philanthropy, and non-profit. Her expertise is leveraging an understanding of how learning is understood from a neurological perspective combined with how we understand behavior and social interactions to drive meaningful change. Danielle has provided leadership to a research team investigating the use of varied sets of data to predict human performance and a team developing and validating very large-scale knowledge assessments to predict performance. She has also taught assessment design at the graduate level. She is currently leading a global initiative to improve aspects of the training system, standards, and procedures. She enjoys learning, supporting the meaningful development of others, and advising leaders on how to catalyze their talent.

45

Chip Bennett

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Assistant Director, CAI

Chip Bennett, Assistant Director, Global C&Q, CAI is a QRM SME and lead CQV Program Development SME. A Project Manager and Senior Validation Engineer, Chip is a PMI® Certified Project Management Professional (PMP) with 20 years of experience in the pharmaceutical and regulated non-pharmaceutical industries and with expertise in risk-based verification, aseptic manufacturing, cleaning validation, quality systems, and owner project management. Chip is responsible for developing and implementing Quality Risk Management (QRM) based Commissioning and Qualification programs and projects, with a particular focus on assessing and training clients regarding development, implementation, and transition to risk-based approaches.