For a number of years now there has been an increasingly number of CGMP violations involving data integrity during CGMP inspections as observed by the FDA. One of the most important responsibilities of the industry is to ensure data integrity is implemented. Data Integrity verification ensures the safety, efficacy, and the quality of drugs as per cGMP standards for biologics and medical devices. These CGMP violations have generated serious concern have led to numerous regulatory actions which have included warning letters, 483 observations, import alerts, and consent decrees. All of our webinar attendees will achieve a comprehensive understanding of FDA’s regulatory expectations for Data Integrity. Attendees will obtain the know-how and the confidence to review practices at their own site and identify gaps in their own practices. Areas Covered in the Session : Comprehend the current regulatory position on data integrity Ascertain the criteria for data integrity Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory Learn about approaches to improve data integrity in a laboratory environment 21 CFR Part 11 compliance FDA citations related to data integrity issues Who Should Attend: Site Quality Operations Managers Quality Assurance personnel Plant Managers and Supervisors Manufacturing Superintendents and Managers Regulatory Affairs Managers


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