Collaborative Efforts Address Key Data Integrity Challenges

Ganapathy Mohan

Ganapathy Mohan*, Ganapathy_mohan@merck.com, is executive director, global quality compliance, Merck & Co., Inc., Kenilworth, NJ, USA.

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Christopher Turner

Christopher Turner is associate director, quality laboratory practices, Bristol Myers Squibb.

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Dennis O’Connor

Dennis O’Connor is senior associate director, GMP QA, Boehringer Ingelheim.

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Lisa Fink

Lisa Fink is senior quality technical consultant (retired), Baxter Healthcare Corporation.

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Thomas Purdue

Thomas Purdue is quality analyst V, Boehringer Ingelheim.

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Jeffrey Beebie

Jeffrey Beebie is director and GLP QA team lead, Pfizer, Inc.

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Kerri Robles

Kerri Robles is director, quality laboratory practices, Bristol Myers Squibb.

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Karen Waetjen

Karen Waetjen is director, GCP/GLP Compliance, Amgen.

BioPharm International, BioPharm International-03-15-2021, Volume 2021 eBook, Issue 1
Pages: 36-38

Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.

Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.

Read this article in BioPharm International's Regulatory Sourcebook March 2021 eBook.

About the authors

Ganapathy Mohan*, Ganapathy_mohan@merck.com, is executive director, global quality compliance, Merck & Co., Inc., Kenilworth, NJ, USA.; Christopher Turner is associate director, quality laboratory practices, Bristol Myers Squibb; Dennis O’Connor is senior associate director, GMP QA, Boehringer Ingelheim; Lisa Fink is senior quality technical consultant (retired), Baxter Healthcare Corporation; Thomas Purdue is quality analyst V, Boehringer Ingelheim; Jeffrey Beebie is director and GLP QA team lead, Pfizer, Inc.; Kerri Robles is director, quality laboratory practices, Bristol Myers Squibb; and Karen Waetjen is director, GCP/GLP Compliance, Amgen; all authors are members of the IQ Consortium.

*To whom all correspondence should be addressed.

Article Details

BioPharm International
eBook: Regulatory Sourcebook, March 2021
March 2021
Pages: 36–38

Citation

When referring to this article, please cite it as G. Mohan et al., “Collaborative Efforts Address Key Data Integrity Challenges," BioPharm International Regulatory Sourcebook eBook (March 2021).