Webinar Recording - FDA Part 11 Inspections: A Primer for Successful Execution

Instructor: Jasmin Nuhic, Senior Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert

Medtronic, Inc.

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Webinar Content

• Introduction: 21 CFR Part 11 FDA Regulation

• Preparing for the Inspection: "Stage room" setup, facilitation and staffing

• Managing a Part 11 Inspection: "Faces" of the organization and process/system being audited, Information flow - utilization of the stage room, Recording information, questions being asked, Time management

• Areas which FDA Investigators will target, including: Labeling systems/software, Change control systems, CAPA systems, "All Part 11 systems must be validated; yet not all validated systems must be Part 11 compliant"

• FDA inspection Commonly Asked Questions. Examples include: Is data transcribed from paper records into the electronic record?, Is there an audit trail?, Edit checks and data logic checks?, If the sponsor discovers data errors, how are investigators informed and corrections made?

• Appropriate Responses During the Inspection: Suggestions will be offers as how to respond appropriately to FDA investigator questions, including what to do when you do not know the answer

• FDA Inspection Finding - Latest Industry Trends and Warning Letters: What the latest inspection findings from FDA mean for your company

• Benefits of Compliance with Part 11

• Information Resources: FDA website, Other industry sources

What Attendees Will Learn in This Webinar

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

➢Basic elements of 21 CFR Part 11 Regulation

➢How to Prepare for an FDA Part 11 Inspection

➢Effective Management of an FDA Part 11 Inpection

➢Areas FDA Investigators will Target During an Inspection

➢FDA Investigator's commonly asked questions

➢Appropriate Responses to FDA Investigator's questions

➢FDA Inspection Findings and Industry Trends

➢Practical Examples of Audit Questions

➢Benefits of Compliance with Part 11 Requirements

➢Training Requirements

➢Options for non-compliance

➢Necessary Tools to Assess Potential Gaps in your Own Systems

Questions and Answers

There will be a 15 minute question and answer period for attendees to submit questions on their systems - currently in use or being developed, implemented or being considered. If we are unable to answer your question due to time constraints, our instructor Jasmin Nuhic will provide a response after the webinar concludes.

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

➢Quality Systems Change Owners

➢Software Developers

➢Influencers or Decision Makers for new systems

About Your Instructor:

Jamin Nuhic is currently a Senior Compliance Quality Engineer and 21 CFR Part 11 Subject Matter Expert at Medtronic, Inc. He has over 10 years of experience in regulated (FDA) industry, and 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 a Subject Matter Expert for his company on 21 CFR Part 820, Part 11, ISO 13485 and 9001. He also serves on Medtronic’s training and development board.

Medtronic

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 conditions.

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