The principles of 21 CFR part 11, software validation, and computer system validation are discussed in detail throughout this webinar. It provides information on firm compliance, such as gamp, qualification, and validation. Part 11 of the industry standards for sops, data transmission, audit trails, and electronic signatures are covered in this course. In the webinar, the main issues and how to prevent them are broken down in depth. areas such as these were discussed throughout the session: Figure out how to prevent getting a letter 483 or a warning letter. Which types of software need to be validated, and which ones don’t? It is important that you comprehend gamp, qualification, and validation. Study not just the words but also the spirit of the rules and regulations. Examine the regulatory requirements for the three key areas of part 11 compliance, which are standard operating procedures (SOPs), software product features (features), and validation documentation. Gain an understanding of the most up-to-date industry standards for computer systems, including those pertaining to data transmission, audit trails, electronic signatures, and security. Gain an understanding of the computer system validation process by learning its who, what, where, when, and why. who will come out on top: it gmp, gcp, and glp specialists, as well as QA/QC laboratory workers and supervisors fast contact information: webinars@globalcompliancepanel.com, 800-447-9407 or 302-288-6884 for Global Compliance Panel in the United States of America. http://www.globalcompliancepanel.com
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