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

RECORDING

Recorded 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.

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WEBINAR SUBJECT MATTER CONTENT

Sources of Requirements and Idea Generation

➢Where do requirements come from

➢ Who provides requirements

➢Techniques to elicit requirements

➢The collaboration process – How requirements arise from the thoughts of many

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

➢Measuring risk mitigation effectiveness

Requirements Reuse and Change Management

➢Tools and Why They Are Valuable

➢Common Tools - Manual versus Automated Tools

➢Reuse – How generic is your requirement

Revising or Deleting Requirements

➢When do requirements Go Away

➢Old versions as a source for investigation

➢To remove/version/redline

Non-Functional Requirements

➢What are non-functional requirements

➢Where do non-functional requirements reside in project documentation

➢Testing non-functional requirements

Requirements in a Rapidly Changing Environment

➢Keeping them current

➢Quick review and approval

➢Change Impact Assessment

Organizing and Prioritizing Requirements

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

➢Reasons for requirement organization and prioritization

➢Prioritization methods

WHAT YOU WILL LEARN ATTENDING THIS WEBINAR

Attendees will be equipped to integrate requirements development, management and testing into their software validation projects. They will understand the difference between requirements and design, and will know the importance of early establishment of a requirement configuration management and change control process.

QUESTIONS AND ANSWERS

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 instructors Jay King or John Janeri will provide an email response after the webinar concludes.

WHO SHOULD ATTEND THIS WEBINAR

Individuals with experience in GMP regulations, drug manufacturing processes and those involved in the manufacture, sale and distribution of controlled substances, including drugs which contain a controlled substance. Individuals who work in Regulatory Affairs, Quality Assurance, Validation, Quality, Operations, and Manufacturing should attend this webinar.

ABOUT YOUR INSTRUCTORS

Jay King currently is Senior Manager, Software and New Product Quality at LifeScan, a Johnson & Johnson Company. He joined LifeScan in 1999. He has previously worked at Medeva Pharmaceuticals and Bausch & Lomb in a variety of validation-related job positions. He has served as an instructor for numerous industry conferences on software quality and computer validation-related topics. Mr. King received his BS degree in Industrial Engineering (BSIE) at the Rochester Institute of Technology and an MA in Leadership at St. Mary’s College of California.

John Janeri currently is President of Compliance House, Inc., where he advises clients in developing high quality validation and software assurance documentation. Much of his consulting work deals directly with FDA compliance to 21 CFR Part 11 and helping companies develop interpretations of Title 21 regulations. He is currently assisting in the development of security policies and procedures, and performing internal quality audits and external auditing of software suppliers and vendors. Mr. Janeri has a BS in Mathematics/Computer Science from Northeastern University, and an MS in Computer Science from Ohio University.

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