Webinar Recording-21 CFR Part 11: A Primer for Implementing Audit Trail

Instructor: Jasmin NUHIC, Senior Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert, Medtronic, Inc.

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➢Invite as many co-workers as possible for this training. Quality content training for one low price (only ONE login allowed - must be in one location). In addition you also receive:

➢PowerPoint Presentation (PDF)

➢Webinar recording

➢Audit Trails Frequently Asked Questions

➢Free Membership in enKap's FDA Compliance learning community - simply fill out a profile

Webinar Content

➢Part 11 Regulation-Subsection Related to Audit Trail: Interpretation of Section 11.10 Controls for Closed Systems

➢Types of Audit Trails:System-application-based vs. operating systems

➢Two Strategies of Implementing Compliant Audit trails: Version control and audit trail control

➢Audit Trails Pros and Cons: How the audit trail can be your best friend and/or worst enemy

➢Shoulds and Shouldn'ts:What the audit trail should do and should not do (Outsourcing; Encryption) ➢The Three Most Common What Ifs? :Hybrid systems, Legacy systems, MS Access systems

➢FDA: Next Steps Related to the 21 CFR Part 11 Regulation (including audit trails)

➢Other Areas Related to Audit Trail: Training, Change control, FDA inspections, Risk management

➢Commonly Asked Questions Related to Audit Trails

QUESTIONS AND ANSWERS

There will be a 15-minute question and answer period for attendees to submit questions. If we are unable to answer your question due to time constraints, our instructor Jasmin NUHIC will provide a response after the webinar concludes.

WHAT ATTENDEES WILL LEARN FROM ATTENDING THIS WEBINAR

In this webinar, you will review or learn the following:

➢How to interpret the Part 11 regulation (section related to Audit Trails)

➢Different types of audit trails

➢Different strategies about implementing audit trails

➢Pros and cons of audit trails

➢Things to do and not to do with audit trails

➢ What to do with legacy systems, hybrid systems and Microsoft Access systems related to audit trails

➢Some of the most commonly asked audit and other questions about Audit Trail including risk related questions

➢FDA’s plans about the 21 CFR Part 11 regulation (audit trails) for the future

WHO SHOULD ATTEND

This webinar is an ideal presentation for those individuals in your organization involved in the following functions:

➢ Quality compliance

➢Quality auditors

➢ Quality engineering

➢Management representatives (to ISO and/or FDA)

➢ Validation specialists/engineers

➢ Business analysts

➢Software developers

➢Influencers or decision makers for new systems

This recording is now part of a CONTENT Package - Click Here for more details

ABOUT YOUR INSTRUCTOR

Jasmin NUHIC, Sr. Compliance Quality Engineer and 21 CFR Part 11 SME, Medtronic, Inc.

Jasmin has over 10 years of experience in regulated (FDA) industry. He considers himself a possibilities identifier with vast experience in quality management systems, quality auditing, quality controls, supplier quality management, project management, training and management information systems (including coding). He serves as an SME for his company related to 21 CFR Part 820, Part 11, ISO 13485 and 9001. He enjoys working with others and also teaches part-time at a University. For more information, including education and past experience, please visit Jasmin’s profile on LinkedIn: http://www.linkedin.com/in/jasminnuhic

Medtronic, Inc. operates manufactures and sell device-based medical therapies, including: Cardiac Rhythm Disease Management (CRDM), Spinal, CardioVascular, Neuromodulation, Diabetes, Surgical Technologies and Physio-Control. Through these seven operating business units, the company develops, manufactures and markets its medical devices in more than 120 countries. Its primary products include those for cardiac rhythm disorders, cardiovascular disease, neurological disorders, spinal conditions and musculoskeletal trauma, urological and digestive disorders, diabetes, and ear, nose and throat.