Federal Bureau of Investigation

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US Attorney's
Office - PA / Eastern

Managed and Produced by:

The Hollis 
Group, Inc.

Wednesday, 26 May 2004

Session I

IEEE-Based Verification, Validation, and Qualification of an Automated Clinical Supply Facility

          Instructor: Barbara L. Meserve, VP, Quality Services, AccuLogix, LLP

AccuLogix, LLC takes a highly innovative, “sponsor integrated” approach to clinical systems logistics. Their state of the art clinical supplies facility in Bristol, PA includes project and product management, manufacturing, materials handling, quality assurance, and drug accountability in an integrated Logistics system. This system incorporates automated security and surveillance records into batch records. The system has been inspected and approved by the DEA as suitable for use with Schedule II substances. 

ABOUT THE INSTRUCTOR: Ms. Meserve has a unique and effective skill set that combines expertise in clinical research, QA / QC, and manufacturing support with information systems design and validation. She has successfully managed departments and projects and she has also designed and conducted technical and management training programs.

Ms. Meserve has more than 20 years of experience in the Pharmaceutical and Medical Device industries, where she has held technical and management positions in Clinical Analysis, R&D, Quality Control, Manufacturing, Quality Assurance, and Information Systems. She holds a BS in Medical Technology from Notre Dame College.

Session II

Security Technology and Protocol: An Executive Briefing

          Instructor: Thomas Quinn, CISSP, AAA, President, The Hollis Group, Inc.

Session description pending

Thomas Quinn, President and a founder of The Hollis Group, Inc., designs, installs, and validates information systems for the bio-pharmaceutical and medical device industries. He specializes in the qualification of the Computer and Network Infrastructures (CNIs) underlying distributed and net-based clinical, research, laboratory, manufacturing, and engineering systems. A frequent lecturer at industry symposia with an extensive publication history, he is the course developer and lead instructor for numerous industry training courses. These include the PDA courses in electronic records and signatures, electronic document management systems, and electronic batch record systems.

Mr. Quinn is a charter member of the Internet and Information Technology Advisory Committee of the  American Arbitration Association, and he serves as a Neutral for the Association. Mr. Quinn holds a bachelor's degree in Physics from LaSalle University.

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