Overview: Audit trails are major requirement for many software applications regardless of an industry or users. This is especially true when it comes for Pharma and medical devices companies and other businesses that have implemented or are planning on implementing 21 CFR Part 11 and striving to comply with the same regulation. Why should you attend: Increase understanding of the Part 11 regulations; improve compliance and meeting the regulations when it comes to different types of audit trails. Areas Covered in the Session Subsection of Part 11 and Interpretation of the subsection Types of audit trails and Strategies of implementing compliant audit trails Audit Trail Pros and Cons Audit Trail As an Auditing Tool Audit Trail Shoulds and Shouldn’ts What if’s? Commonly asked questions about Audit Trail What is next about 21 CFR Part 11 Who Will Benefit: Quality Managers Quality Auditors Small Business Owners CAPA Investigators FDA Inspectors Software Engineers and Developers Consultants Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. AMAZINES.COM
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Online Training, 21 CFR Part 11, audit trails, RAPS, striving,
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