Roberta Goode, an industry expert, approached FDA in early 2018 to recommend the first Collaborative Community on the topic of Benefit-Risk. Based on industry feedback gathered from her medical device manufacturing clients over the past 30 years, Goode identified gaps in industry and FDA interpretation and implementation of risk-assessment and...
Producing consistent and reliable data is the function of any laboratory; this is necessary in order to make decisions about the quality of the finished product. Microbiology laboratories supporting pharmaceutical and healthcare facilities will, under the quality system, be subject to periodic audit.
Training modules should be managed utilizing the three stages of the validation lifecycle approach to provide a structured approach including design and development; execution, and follow-up monitoring and maintenance.
This paper aims to examine the current regulatory expectations from the prospective of both data integrity and data privacy and proposes that when it comes to cloud computing, the most powerful tool organizations possess to assure data quality and security lies with their third party supplier contracts.
This discussion covers aseptic testing - a representative aseptic test procedure , along with consequences of test failures, test problems, and the role of management to get your operations up-to-speed.
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Cleaning methods for pharmaceuticals are developed and validated for use in the cleaning of manufacturing equipment. Are these same methods required to be used in the analytical laboratory for cleaning glassware, tubing, and other analytical equipment? Must these laboratory cleaning methods also be validated?
This paper discusses how FDA is instructed to review out-of-specification (OOS) investigations. Understanding their review concerns aids in preparing for subsequent FDA Inspections.