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WEBINAR: Requirements: Your Foundation for Conducting Successful Computer System Validations

Event Details

WEBINAR: Requirements: Your Foundation for Conducting Successful Computer System Validations

Time: January 26, 2010 from 11am to 12pm
Location: Your Computer
Event Type: webinar
Organized By: enKap
Latest Activity: Dec 11, 2009

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Event Description

Tuesday, January 26, 2010

11:00 a.m.-12:00 p.m. Eastern Standard Time (United States)

Instructors: Jay King, Senior Manager, Software and New Product Quality, LifeScan, a Johnson & Johnson Company

John Janeri, President, Compliance House, Inc.

REGISTER NOW and Purchase the included Recording in our enKap Store


The low $149.00 Webinar Registration fee includes:

➢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). In addition you also receive:

➢PowerPoint Presentation (PDF)

➢Webinar recording

➢Frequently Asked Questions and Answers Document on subject matter content

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


WEBINAR SUBJECT MATTER CONTENT


Sources of Requirements and Idea Generation

➢Where do requirements come from

➢ Who provides requirements


Differences in Requirements for Products, Processes and Tools

➢Considerations for Product Requirements

➢Considerations for Quality System (processes and tool) requirements


Linkages of Requirements to Risk Management

➢Requirements mitigate risks

➢Risks reveal requirements


Requirements Reuse and Change Management

➢Tools and Why They Are Valuable

➢Common Tools - Manual versus Automated Tools


Revising or Deleting Requirements

➢When do requirements Go Away

➢Old versions as a source for investigation


Non-Functional Requirements

➢What are non-functional requirements

➢Where do non-functional requirements reside in project documentation


Requirements in a Rapidly Changing Environment

➢Keeping them current

➢Quick review and approval


Organizing and Prioritizing Requirements

➢Why You Don't Need to Believe In the Concept

➢Reasons for requirement organization and prioritization


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