Speaker Profile

Janet Gough

Director, GXP Documentation

Janet Gough has extensive experience as a consultant to the pharmaceutical, biotech, and medical device industries. She designs systems for compliance with binding regulations and conducts training accordingly. She assists companies in the preparation of documents including research and development reports, procedures, clinical documents, and regulatory filings. She also writes and edits journal articles.

She has been a director of technical communications for a biotech company, and has taught English in university graduate and undergraduate programs. She is the author of Write It Down: Guidance for Preparing Effective and Compliant Documentation, 1st and 2nd Ed. and co-author of Electronic Record Keeping: Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164, both from CRC Press.

She is the author of Hosting A Compliance Inspection and the co-author of The Internal Quality Audit, The External Quality Audit, and Risk Based Software Validation from Davis Horwood International (DHI) and the Parenteral Drug Association (PDA).

She is also a contributing author to the Clinical Research Manual from Euromed Communications Ltd. She is listed in the Marquis Who's Who in Medicine and Healthcare.

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