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31

Thomas Miller

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Senior Enterprise Architect, Azzur Technology Consulting Services

As a Senior Enterprise Architect, Thomas (Tom) Miller serves as a trusted advisor and subject matter expert for our clients across a number of industries, including pharma/biotech, healthcare, and manufacturing. Tom joined Azzur Group from TUV OpenSky, where he led their Secure Cloud Enablement Practice and managed a team responsible for large-scale Enterprise transformation projects, such as merger & acquisitions work, data center consolidation, and cloud enablement. Tom specializes in assisting enterprises to move forward to cloud. Tom holds a Bachelor of Science in Computer Science from Drexel University in Philadelphia, PA.

32

Abhijit Ray

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CTO And Co-Founder, Aventior, Inc.

Abhijit is the CTO and co-founder of Aventior. With over 20 years in technology and working with some of the leading Biotech and Pharma companies, Abhijit has been instrumental is designing new AI solutions for process automation including document processing. Aventior’s solutions for Continued Process Verification and Data Management helps Biotech firms help decrease their efforts in data management, meta-data management and compliance.

33

J. Loren Smith

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Senior Manager, Global Compliance & Ethics, Computer, BioMarin Pharmaceutical

Loren has over 28 years of experience specializing in computer systems compliance (from the IT, QA, and Compliance perspectives) in medical device, biotech, pharmaceutical, analytical instrumentation, and software companies. Loren has also been an instructor at University of California, Berkeley, since 2006, teaching computer systems compliance to students in clinical research.

34

Kim Munsell

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Senior CSV & Compliance Manager, Janssen R&D

Kim Munsell is from the Philadelphia area and has worked for Janssen R&D since 2007. She has a bachelor’s degree in biology from Eastern University and a master’s degree in pharmacology from Thomas Jefferson University. She started her career with a short stint as a Quality Control analyst in a GMP pharmaceutical manufacturing plant, and then worked as a protein biochemist and biologic inventory manager in a GLP Janssen BioTherapeutics laboratory for almost 11 years. In 2018, she joined the Lab Operations and Data Systems organization within Janssen BioTherapeutics and was recently promoted into the role of Sr Computer Validation & Compliance Manager. She is passionate about delivering streamlined operational processes and easy-to-use electronic systems that are in compliance with GLP, DDI, and CSV regulations.

35

Patrick Mullin

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Senior CQV/QAV Consultant, DPS Group Global

Patrick Mullin has over 15 years of experience in vaccine and biotech operations which include commissioning, qualification, and validation (CQV) management for clinical and commercial scale biotech operations. Patrick's core focus is with the creation, implementation, and maintenance of CQV programs specializing in critical utilities, process equipment (upstream/downstream production and fill finish), process automated systems, and sterilization/cleaning support systems at pilot plant and full commercial scales.

36

Chris Maughan

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Managing Director, Thermal Compliance Ltd

Chris is the Managing Director of Thermal Compliance Ltd, who specialize in the qualification of Thermal Systems. With over 15 years of hands-on validation experience in the Thermal and Biological Validation of Sterilization processes alongside temperature, humidity and CO2 mapping of Controlled Temperature Units. Chris has a detailed knowledge of validation systems and the use of wireless dataloggers, for the Qualification of Thermal Systems.

37

Eric Collier

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Discipline Lead Automation And IT, Commissioning Agents, Inc.

Mr. Collier is an experienced leader with more than 27 years as a project manager, software engineer, and IT consult. More than 17 of those years have been spent in the Pharmaceutical, Biopharmaceutical and Medical Device industries leading 21 CFR Part 11, Computer System Validation (CSV), Data Integrity, and Good Automated Manufacturing Practice (GAMP) assessment, implementation, compliance, and remediation projects.

38

Gamal Amer

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Principal, Premier Compliance Services

Dr. Amer, a chemical engineer by training, has 40 years-experience in the pharmaceutical and related industries. He has held senior management positions with leading pharmaceutical, consumer products, and engineering consulting companies. His experience includes comprehensive process design in bulk pharmaceutical chemicals manufacturing, biotechnology manufacturing, pharmaceutical solid dosage manufacturing, and containment of potent and radioactive therapeutics. He is also experienced with facility development for therapeutic products operations. Dr. Amer is a recognized expert in GMP compliance and validation.

39

Adil Seddiq

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Technical Manager (CSV), Azzur Group

Adil Seddiq is a Technical Manager with Azzur Group. With more than 17 years of FDA-regulated industry diverse experience in small molecule/biopharmaceuticals, secondary packaging and equipment manufacturing. Throughout his career, Adil has specialized in Computer Systems Validation, Risk Management, Inspection/Audit Management, and Vendor Management through Validation and QA positions at Eli Lilly & Co. and Glatt Air Techniques. He is a recognized subject matter expert on risk-based systems validation, process improvement, and quality culture.