Webinar Recording - Conducting Effective Internal/External Part 11 Audits: An Auditor Tells How

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

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➢PowerPoint Presentation (PDF)

➢Webinar recording

➢Part 11 Auditing Checklist Document

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Webinar Content

Pre-Audit Planning: Planning Audits (starts with overall audit schedule)

➢Differences between a Part 11 audit and a typical quality systems audit

➢When to include Part 11 in an audit

➢Why a Part 11 audit is always part of a bigger picture

➢Differences between a Part 11 audit and a typical quality systems audit

➢Team – process compliance audit team members vs. the Subject Matter Expert (SME) (who are SMEs in this case)

➢Auditing the entire process and identifying the system that supports it vs. auditing the system that you’re using: Locating areas that support the process

➢“Fishing for information” – especially in the case of a supplier audit

➢Be ready to do extra work

➢Example of a detail that should be planned: Computer validation audit where the mainframe computer could not print data until 24 hours after the request

➢Systems-how they support the process

➢Software validation-hardware IQ and OQ

➢Understand the training modules vs. the objects of the system

➢Part 11 regulation

Executing the Audit (internal and external)

➢Differences in the execution of an internal and external audit with and without Part 11 being in scope

➢Time management (remember: it is the system you are dealing with, NOT the people): Spending time in the conference room vs. on the manufacturing floor, Observing in production or a simulated production environment

➢ Locating areas that support the process: Your friends: master validation plan, validation scripts and audit trail

Common Audit Findings

➢Test Scripts-not addressing validation requirements

➢Initial evaluation of software-decision trees, checklists

➢Not validating all generated records

➢Determining “out of scope” records

Common Pitfalls in Auditing for Part 11 Compliance

➢Trying to cover the entire regulation

➢Focusing on the entire system vs. one system

➢Hybrid systems-records stored electronically vs. hard copy signatures on paper

➢Safeguarding records-how far to “dig” in your audit

CAPA process and closure of the audit

➢"Standard” requirement of 30 days challenged?!

Post Audit:

➢What to expect from auditee responses and follow up on the audit where there were observations which require CAPA

➢90% of time, there are differences from the “regular” compliance audit

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 effectively prepare and plan for internal and external audits where Part 11 is in scope.

➢ Differences in executing an internal and external audit with and without Part 11 being in scope

➢Time management (remember: it is the system you are dealing with, NOT the people)

➢Impact on CAPA process and closure of the audit: “Standard” requirement of 30 days challenged?!

➢What to expect from auditee responses and follow up on the audit where there were observations which require CAPA: 90% of the time, there are differences from the “regular” compliance audit

➢Common audit findings

➢Common pitfalls in auditing for Part 11 compliance

➢And more

WHO SHOULD ATTEND

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

➢Quality compliance

➢Quality auditors

➢Quality engineering

➢Management representatives (to ISO and/or FDA)

➢Validationspecialists/engineers

➢Business analysts

➢Software developers

➢Influencers or decision makers for new systems

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.

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