Best practices for selecting E-QMS system

Duration: 90 Minutes
This course will cover considerations and requirements when selecting an Electronic Quality Management System (E QMS).Due to the current climate of regulatory compliance there is a need for companies to select the appropriate electronic quality management systems (E QMS). Finding the right solution for your company can be a confusing and stressful activity. Often, organizations will select a system that allows some of their workflows to execute seamlessly, but still did not get everything they wanted.
Electronic Quality Management System
Instructor: Susan Leister
Product ID: 501443
Objectives of the Presentation
Key goals of the Webinar will include learning:
    Before the Search
    • Discuss plans for introducing the change internally, corporate culture adjustments
    • Identify individual/departmental roles
    Plan the implementation
    • For each area, work through what is required - scope; promotion; training; participation; documentation; review and revision
    • Identify who will take the lead in each part
    • Use project management principles to identify the activities, timescale and resources
    Begin the Search: Critical Elements to Consider
    • Adaptability
    • Web based versus server based
    • Analyzing data - reporting
    • Taking quality to the enterprise - scalability matters
    • Integration, will there be a data transfer
    • Validation requirements, understand and plan now
    • Know your audience - end user acceptance
    Implementation and Deployment
    • Look and feel - making the system your own
Why Should you Attend
During this training session, attendees will expand their understanding of how to select an Electronic Quality Management System (EQMS). Many organizations are seeking to move from a paper system to an electronic platform and are confused with the options available. We will discuss the challenges associated with making a major change to a software system, how to identify key stakeholders, and how reporting may be impacted. In addition requirements for validation will be discussed.

At the end of the webinar, you will be able to understand the differences in the EQMS products available, be able to prepare your organization for the changes with implementing an EQMS, and understand validation requirements.

Areas Covered
  • Discuss overall approach to identifying and selecting an E-QMS
  • Discuss the corporate culture change process
  • Review the roles and training needs
  • Discuss report functions
  • Discuss validation requirements for different types of systems
Who will Benefit
  • Quality Assurance/Quality Control Managers
  • Regulatory/Compliance Staff
  • IT
  • Anyone else who has a collateral role in reviewing or approving a company-wide QMS
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Training USB Flash Drive
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. Susan Leister serves as the director of quality assurance at Technical Resources International Inc. with over 20 years of experience in the pharmaceutical and medical device industry. She has validated over 40 software systems in the past few years and is very fluent in software validation requirements and compliance. She is also faculty for both graduate and undergraduate studies at the University of Phoenix. In addition to a bachelor's degree in biochemistry and molecular biology, she has an MBA, a doctorate in organizational management with a focus on leadership, and holds certifications from the American Society of Quality (ASQ) as a Certified Quality Auditor and a Six Sigma Black Belt.Dr. Leister has broad experience in GCP, GLP, and cGMP. She serves the ASQ Section 509 Executive Committee as the chair-elect and has been serving for the past four years as a Maryland Performance Excellence Award Examiner.
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