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Participants are welcome to bring their own examples for group discussion sessions.The workshop emphasizes practical issues such as: The course provides ample opportunities for group discussions, case studies and exercises.What Are The Basic Principles Of Data Integrity And GMP Data Control?

The two cases were combined and heard by Judge Alfred Wolin, and it is Judge Wolin’s landmark decision that became the stake in the ground for current data integrity expectations in the GMP industries.This encompasses not just our testing and production processes, but also our investigation process for those anomalies.Per the FDA’s OOS guidance, OOS investigations should occur using a predefined procedure — the procedure defines a standard process but still allows for the appropriate scientific experimentation as needed in the appropriate parts of the process to identify the cause of the anomaly.It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards. FDA felt that Barr Labs’ control practices — including release of product not meeting specifications, inadequate investigations of failed product, failure to control product manufacturing steps, and averaging of testing results — were not sufficient to ensure that products meeting its quality standards were distributed to the public. The company’s argument, though, was that the practices FDA claimed it needed to follow were not specifically required by the GMPs.To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it. In response, Barr sued FDA for practicing “ad hoc” drug regulation.




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