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

Karen Waetjen 

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.

Pharmaceutical Technology's Regulatory Sourcebook 

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.


eBook: Regulatory Sourcebook, March 2021
March 2021
Pages: 48–51

When referring to this article, please cite it as G. Mohan et al., “Collaborative Efforts Address Key Data Integrity Challenges,"

 Pharmaceutical Technology Regulatory Sourcebook eBook 

Articles

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.
