Peter Baker, President, Live Oak Quality Assurance LLC, is a GXP consultant focused on improving the quality of medicines by providing training and consulting services to organizations looking to improve the quality of their data integrity assurance strategy.

2018年2月26日 · Peter E Baker has conducted inspections on 159 sites in 4 countries as of 26 Feb 2018. See below for a list of the FDA enforcement documents resulting from those inspections.

Peter E. Baker, President, Live Oak Quality Assurance LLC, has been consulting nationally and internationally since 2019. Prior to consulting, Peter spent 11 years as a U.S. FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in …

2024年12月12日 · The FDA doesn’t have enough experienced investigators to figure out what’s wrong at factories where there are signs of trouble, said Peter Baker, a former FDA inspector who consults on ...

2023年6月1日 · In Peter Baker’s first presentation with Redica Systems on quality intelligence, he spells out how he sees pharma companies actually reaching the goal of modern quality intelligence, based on FDA guidance, 483s, and other sources—a long road trip with several stops and no shortcuts.

Peter E Baker is a meticulous auditor who places a strong emphasis on data integrity, laboratory controls, and stability studies. He is particularly concerned about ensuring that pharmaceutical products are stored and labeled in accordance with substantiated stability data.

2022年10月14日 · When it comes to data integrity, Peter Baker has seen it all. He is well-known in the industry as a former FDA investigator, and now heads his own firm, Live Oak Quality Assurance.

In my book Bottle of Lies, 5 I detail the revelatory inspections of the FDA investigator Peter Baker, who used unique methods to uncover the truth inside foreign drug plants. Instead of asking the plants for printouts of data, he looked directly inside the computer systems.

Get Peter Baker's official FDA inspection documents. Gain valuable insights from their Form 483s and EIRs to ace your next inspection.