Data Integrity requirements are among the most strenuous that regulated industries has to comply with. Data Integrity can result from lack of awareness, employee errors, failure to check accuracy of data, software or system malfunction, configuration problems with electronic data handling, or misconduct by employees. Your electronic records must be trustworthy and reliable across their entire data lifecycle, from initial data creation all the way through long-term archival. Data Integrity (DI) has become a focal point of FDA inspections, as is evidenced by the number of warning letters citing data integrity and the resulting number of import alerts. Company Quality Management Systems are being scrutinized as to how the integrity of raw data (both electronic and manual) generated in the Quality Control Laboratory and in Operations (Manufacturing and Engineering) can be assured. The FDA is now including recommendations for recipients to obtain 3rd party assistance when addressing DI issues.
With the number of inspections on rise, FDA auditors are on a close watch on pharmaceutical companies with the focus being on quality so that the drugs which are exported to the global market are safe to consume. A sincere and thorough approach to formulate this response is required in order to convince the FDA that the observations noted have been taken into consideration and a plan of action has been implemented. It has also been noted that an indefinite response to a 483 can lead to a warning letter.
Keeping all this in consideration, CPhI Conferences is pleased to announce the, ‘5th Annual Data Integrity, Reliability and Quality Metrics’ along with an extension to ‘FDA Inspections and Response to 483s’ Workshop scheduled on 26th - 28th June 2019 at Courtyard by Marriott, Mumbai. This practical case-study and highly interactive content-driven workshop will enhance your knowledge to address the Data Integrity issues and upgrade your skills for effective response to a 483.
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