ComplianceOnline

Course "A risk based approach to GxP Compliant Laboratory Computerized Systems" has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion.

Laboratory Computerized Systems and data management operations are increasing in variety, sophistication and complexity in the GxP environment. Widespread reliance on these systems, along with their potential impact on data integrity, and the trend towards cost efficiency within companies, means that companies need achieve GxP compliance of laboratory computerized systems– within a reasonable budget and timeline.

The wide diversity of these systems, coupled with their capability for networking, makes it impractical and inefficient to have single approach to achieve GxP compliance for all systems. For example, a High Performance Liquid Chromatography (HPLC) with a Photo Diode Array (PDA) detector is much more complex than a pH meter, and will require a correspondingly more detailed and complex implementation, control and maintenance approach.

Poor management of laboratory computerized system acquisition, implementation and operation may result in:

  • Failing to meet process and user requirements
  • Unacceptable cost or time overruns
  • Risk of non-compliance
  • Data Integrity issues
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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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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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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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