Engaged. Knowledge. Application
Includes a Webinar Recording, Powerpoint Training Presentation, Audit Checklist, frequenty asked questions and answers.
➢ 1.Software Auditing: It's Not Just About Compliance (One Hour Webinar Recording)
➢ 2.Software Auditing: It's Not Just About Compliance (PowerPoint Training Presentation)
➢ 3.Supplier Audit Tool Creation Checklist
➢ 4.Frequently Asked Questions and Answers
Click here to view complimentary excerpt

1.& 2. Software Auditing: It's Not Just About Compliance (One Hour Webinar Recording and PowerPoint Training Presentation)
➢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
Supplier Audit Tool Creation CHECKLIST
This four-page document can be utilized by industry professionals to help create their own supplier software audit checklist.
Frequently Asked Questions and Answers DOCUMENT
Click here to view complimentary excerpt
Our subject matter expert answers the questions listed below:
➢Isn’t auditing against 21 CFR enough to meet regulatory obligations for software supplier audits?
➢When should software supplier audits be conducted?
➢How long should software supplier audits take?
➢What constitutes objective evidence in a software supplier audit?
➢Who should be in the room during an audit?
➢What happens if a software supplier fails an audit?
Instructor: Eric Henry, former Corporate Software Quality, Boston Scientific
Software Supplier Auditing CONTENT Package is only $99.00
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