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Bibliographic Details

Title: Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (1st Books Library)
Publisher: 1st Book Library
Publication Date: 2003
Language: English
ISBN 10: 1410737446
ISBN 13: 9781410737441
Binding: Soft cover
Condition: good

About this title

Synopsis

This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib

About the Author

Stephen Goldman is a Senior Compliance Director and Consultant specializing in 21 CFR Part 11 training, assessment, remediation, validation and project management to provide sustainable compliance in the regulated pharmaceutical environment. He has provided Subject Matter Expert guidance and training for gap analysis and remediation of computer systems validation for a major pharmaceutical company under an FDA Consent Decree. He has performed engineering and validation services for two remote data entry systems for use in clinical trials.

He has managed and conducted numerous training programs for end-user training in basic computer operation and use, network environments, custom Lotus Notes applications, and other specialized programs. He has prepared course material and provides training for an ACPE accredited conference on Planning and Remediation of Systems for Part 11 Compliance and Planning and Checking, Part 11 Assessment and Remediation of Systems for Part 11 Compliance.

Mr. Goldman�s background in electrical engineering, manufacturing, defense, pharmaceutical, and biotechnology enables him to relate to most types of business operations. He designs and implements IT solutions to streamline workflows within organizations.