21 cfr part 11 audit trails – ins and outsDocument Transcript
Live Webinar on: How-to Set Up a In-house Customs/Import Operation. Thursday, June 14, 2012 duration : 11:30 to 13:00 AM EDT Description 21 CFR Part 11 is FDA regulation for electronicGet 15 % Discount as a early bird signatures and electronic records. It started byregistrations. Use Promo Key : the pharma - it is a good regulation for medical CGO15 and pharma companies but it is also a good guideline for other industries. Audit Trails play major role in Part 11 compliance - they can be your best friends and/or worst enemies at the same time Attendees will also receive the below Free documents: - 30+ frequently asked questions (free document) and 21Pricing CFR Part 11 Regulation - PDF Print only copy of PowerPoint slides shared by the speaker.Live ( Single registration ) : $189.00Group ( Max 10 Attendee): $249.00 - Q/A session with the ExpertOn Demand (Recording available):$289Get Training CD : $499 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
Who will benefit Description of the topic:Quality Managers Ausir trails are major requirement for many softwareQuality auditors applications regardless of an industry or users. This isSmall business owners especially true when it comes for Pharma and medical devices companies and other businesses that haveCAPA investigators implemented or are planning on implementing 21 CFR PartFDA inspectors 11 and striving to comply with the same regulation.Software engineers and developersConsultantsMore Trainings 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 Should and Shouldn’t - What if’s? - Commonly asked questions about Audit Trail - What is next about 21 CFR Part 11 About Speaker Jasmin NUHIC serves a major medical devices OEM as a Sr. 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. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.