Computer System validation in the Pharmaceutical and Medical Device Industries
My name is Richard Chamberlain, but people call me Richard Chamberlain. Here is my homepage: . I live in United States and work as an Ph.D. at Audioeducator.com.

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Richard Chamberlain - Pharma Training Expert

Richard Chamberlain - Ph.D.

Richard Chamberlain is the President of Executive Consultant Services, LLC, a company that provides consultation to numerous pharmaceutical, contract research organizations, and medical device companies in the areas of computerized project scheduling, strategic planning and computer systems validation. He has broad management experience in a variety of management and technical areas including strategic planning, operational planning, pharmaceutical R&D project management, computer systems development and implementation, and computer systems validation.

Richard completed his Ph. D. Statistics and M. S. Statistics from Iowa State University and B. S. Mathematics from Platteville. He has managed large-scale clinical projects including development and validation of Remote Data Entry systems, Adverse Event reporting, Drug Supplies, project planning and supervision of staffs. Also, he has taught numerous public and in-house courses on various aspects of Computer Systems Validation and Auditing Computer Systems. Richard has assisted in the development and validation of numerous computerized systems in all GxP environments, as well as all varieties of Standard Operating Procedures and other required documentation for compliance to regulations.

He is familiar with the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs. Richard is experienced in responding to FDA Inspections, 483s, and Warning Letters; and use of tools such as Gap Analyses, Risk Management, and Quality Management.

 

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