Live Webinar September 20th, 2012 – 3:00 pm – 4:30 pm EDT
Duration: 1.5 Hours 1.5 Category C PDU – Free PDUs
Presented by: Praxis (REP #1231)

NOTE: Although Praxis is an REP they have stated that this opportunity will not be registered with PMI® as a Category A opportunity. If you have any questions contact Mrs Jamie Morris with Praxis. See below for Category C documentation details.

The prospect of a software quality audit can be intimidating and the work to prepare can seem daunting.However, audits are not generally conducted according to random processes, nor do auditors ask random questions.By learning what to expect, you can be prepared!

In this session, you will receive an overview of standard audit terminology, roles and processes. You will learn how to prepare your validation documentation,standard operating procedures, facilities, and personnel for the software quality audit.

Praxis will review frequently asked questions and checklists from international regulatory guidance. The session will also address approaches to handling problemtopics.

You will learnbest practice tactics for use during the audit. And finally, to help you determine where to focus your preparation efforts, this session will provide statistics from FDA inspections on the most prevalent software quality topics and the most cited typed of computer systems.

• Fundamental audit terminology, roles and practices
• Key US and international regulatory guidelines regarding software quality audits
• Audit preparation for staff, facilities, and documentation
• Common software quality audit questions
• Best practices during an audit
• Accommodating requests for access to computer systems and data
• Most frequently inspected systems and software quality topics

PDU Category C documentation details:

Process Groups: Planning Executing

Knowledge Areas: 4 – Integration 5 – Scope 8 – Quality

• 4.4 Monitor & Control Project Work
• 5.2 Define Scope
• 8.1 Plan Quality
• 8.3 Perform Quality Control

As a Category C, ‘Self Directed Learning’, activity remember to document your learning experience and its relationship to project management for your ‘PDU Audit Trail Folder.’

Click to register for Preparing for a Software Quality Audit