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A risk based approach to GxP Compliant Laboratory Computerized Systems (com...

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A Risk Based Approach to GxP Compliant Laboratory Computerized Systems



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On the other hand, there are major business benefits to both regulated organizations and suppliers, in delivering systems that defined and specified and are easier to support and maintain. Benefits include:

  • Reduction of cost and time taken to achieve and maintain compliance
  • Early defect identification and resolution leading to reduced impact on cost and schedule
  • Cost effective operation and maintenance
  • Effective change management and process for continual improvement
  • Enabling of innovation and adoption of new technology
  • Providing frameworks for user / supplier co-operation
  • Assisting suppliers to produce required documentation
  • Promotion of common, consistent, system life cycle, language and terminology
  • Providing practical guidelines and examples
  • Promoting pragmatic interpretation of regulations



Learning Objectives:

This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation by:

  • Examining the system life cycle and its applicability for most laboratory computerized systems
  • Identifying characteristics that distinguish various types of laboratory computerized systems
  • Developing a rationale for scaling activities and effort based upon risk, complexity, and novelty
  • Defining a strategy for supplier assessments, and the effective leveraging of supplier knowledge, experience, and documentation
  • Applying the GAMP® 5 Quality Risk Management (QRM) approach
  • Defining necessary operational and maintenance activities
  • Recommending an approach to system retirement
  • Leveraging deliverables and activities for very similar or identical systems



Who will Benefit:

  • Lab Director
  • Lab Scientists
  • Computer Validation Professional responsible for defining and managing laboratory computerized systems in regulated life science industries
  • Information Technology (IT) personnel
  • IT support services
  • Management and Laboratory System users
  • Software Developers
  • Suppliers of Computerized systems including suppliers or:
    • Software
    • Hardware
    • Analytical instrumentation
    • System integration services
    • IT support services
  • Regulators



Industries:

  • Pharmaceuticals
  • Biotech
  • Medical Device
  • Radiological Health
  • Blood Products
  • Companion Animals
  • Food
  • Cosmetics
  • Tobacco
  • Academia



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AGENDA
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DAY 01(8:30 AM - 4:30 PM)




  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Lecture 1: Introduction and Background
    • Introductions / Participants’ Understanding / Participants’ Objectives for the Course (Please come prepared to discuss)
    • Background
    • Industry Context
    • Key Concepts
  • Lecture 2: Quality Risk Management
    • Science Based Quality Risk Management
    • Quality Risk Management Process
    • Initial Risk Assessment
    • Implement & Verify Appropriate Controls
    • Review Risks & Monitor Controls
  • Lecture 3: Life Cycle Approach
    • Computerized Systems Life Cycle
    • Specification & Verification
    • Computerized System Validation Framework
  • Lecture 4: Life Cycle Phases
    • Concept
    • Project
    • Operation
    • Retirement



DAY 02(8:30 AM - 4:00 PM)


  • Lecture 5: GxP Compliance
    • Data Integrity
    • Security
    • Defining Electronic Records and Raw Data
  • Lecture 6: Risks & Implementation of Systems
    • Simple Systems (Analytical Balance,pH Meter, Electronic Pipette)
    • Medium Systems (LIMS / ELN)
    • Complex Systems (Robotics)
  • Lecture 7: Supplier Documentation & Services
    • System Development by the Supplier
    • Supplier Assessment
    • Supplier Good Practices
    • Leveraging Supplier Knowledge & Documentation
  • Quiz: Jeopardy!!!!
    • GxP Compliant Laboratory Computerized Systems



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SPEAKER
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Angela Bazigos

Angela Bazigos
CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ . Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.



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