Webinar-Software Supplier Audits: It’s Not Just About Compliance

Instructor - Eric Henry, Senior Manager, Corporate Software Quality, Boston Scientific

➢This recording is now part of a CONTENT package. Read more...

➢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).

➢PowerPoint Presentation (PDF)

➢Webinar recording

➢Frequently Asked Questions & Answers Subject Matter Document

➢Audit Checklist Outline: Areas to Consider When Creating Your Own Tool

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

Webinar Content

➢ Introduction

➢ The typical software supplier audit for a FDA-regulated company (what I’ve seen)

➢ What I really want to know about my suppliers & why the typical audit is not enough

➢ Can just anyone do software audits?

➢ Timing is everything

➢ Which areas do I audit?

➢An interesting audit tool used by Boston Scientific

➢All that comes before, or preparing for the audit

➢In the room: Questions and answers – some tips: The players: The prima donna, The talker, The “lawyer”, The obstructionist, The executive, The angry young man

➢The aftermath of the audit: dealing with identified risks

➢Q&A

WHAT ATTENDEES WILL LEARN IN THIS WEBINAR

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

➢The difference between a compliant supplier and an effective supplier

➢The role of software supplier audits in the supplier selection process

➢Suggested audit areas for both compliance and software engineering maturity

➢How to build a simple tool to aid in conducting audits

➢Some tips for conducting an audit

➢How to balance supplier risks with business need in the aftermath of an audit

QUESTION AND ANSWER SESSION

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, Eric Henry, will provide an email 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

➢Quality management

➢Quality systems change owners

➢Contract management

➢Influencers or decision makers for new systems

About Your Instructor

Eric Henry is the Senior Manager of Corporate Software Quality for Boston Scientific in Massachusetts (United States).

Previously, he was the Manager of Design Assurance for a medical device company in Delaware, Director of a Software Quality Management consulting practice in the Washington, DC area, and Director of Test Management for a securities regulator in the Washington, DC area.

Eric holds a B.S. in Organizational Management and is a Senior Member of ASQ (Biomedical Division and Software Division).

Boston Scientific

Boston Scientific Corporation is a developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties, including cardiology, cardiac rhythm management, peripheral interventions, electrophysiology, neurovascular intervention, endoscopy, urology, gynecology and neuromodulation. The Company’s products are offered for sale principally by three dedicated business groups: Cardiac Rhythm Management (CRM) Cardiovascular, including the Cardiovascular and Neurovascular businesses; Endosurgery, including the Endoscopy and Urology/Gynecology businesses; and Neuromodulation.

➢This recording is now part of a CONTENT package. Read more...