3-Hour Virtual Seminar on Risk Based Service Management and Performance Monitoring for GxP Computerized Systems Operations


Wednesday, February 27, 2019   |   12:00 PM PST | 03:00 PM EST   |   Duration: 3 Hours      

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One Dial-in One Attendee

Price: US$290.00


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Price:US$490.00


Duration: 3 Hours  

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Price: US$340.00

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Price: US$540.00

In this webinar speaker will Provide a better understanding of both the individual Service Management and Performance Monitoring processes and their role in the operations phase of GxP computerized systems, Also Discusses how to leverage supplier resources and expertise to provide support during Service Management and Performance Monitoring.
Angela Bazigos   Product Id : 502278
  Instructor : Angela Bazigos

  More Trainings by this Expert


Overview:

This Webinar specifically addresses the Service Management and Performance Monitoring of the Operations phase of GxP Computerized Systems and describes the development, implementation, and maintenance of efficient, cost-effective, and compliant processes and procedures.

Why should you Attend:

  • Provide a better understanding of both the individual Service Management and Performance Monitoring processes and their role in the operations phase of GxP computerized systems
  • Embed scalable risk-based approaches into the definition and management of those internal and external Service Management and Performance Monitoring processes
  • Discuss how to leverage supplier resources and expertise to provide support during Service Management and Performance Monitoring
  • Discuss how to leverage the increased use of Computerized Systems to support the Service Management and Performance Monitoring Functions
  • Assist organizations in assigning clear roles and responsibilities to required activities for Service Management and Performance Monitoring compliance

Whenever possible, processes discussed will be aligned on the Quality Management System described by ICH Q10 (Pharmaceutical Quality System) and ICH Q9 (Quality Risk Management).

Areas Covered in the Session:

SESSION 1: Overview of the Operations Phase and Risk Management Application
  • Overview of the Operations Phase
  • How the Operations Phase fits into the Quality Management System
  • Operations Phase Processes Lifecycle
    • Capture of Operational Control Requirements
    • Design of Operational Processes
    • Verification of Processes
    • Deployment of Processes
    • Verification of the Effectiveness of Processes
    • Process Relationships
  • Risk Management for Operational Processes

BREAK

SESSION 2: Establishing and Managing Operations Support Services
  • Introduction
  • Roles and Responsibilities
  • Identify Support Needs
  • Select Suitable Support Supplier
  • Establish & Manage Service Level Agreements and Support Contracts
  • Managing the Outsourced Environment
  • Training
  • Routine and Ad-Hoc Support
  • Periodic Review of Support Services
  • Records and Record Content
  • Scalability
  • Related Processes

BREAK

SESSION 3: Establishing and Managing Performance Monitoring
  • Introduction
  • Roles and Responsibilities
  • Plan Performance Monitoring
  • The Monitoring Plan
  • Periodic Review Considerations
  • Records and Record Content
  • Scalability
  • Related Processes

Who Will Benefit:
  • Quality Auditors
  • IT Personnel
  • Validation Personnel
  • Managers/Directors/Supervisors and Personnel related to:
    • IT
    • Validation
    • Quality Management System
    • Quality Assurance
    • Quality Control
    • Product Development
    • Engineering
    • Manufacturing
    • Risk Management
  • Complaint Handling
  • Personnel new to the Regulated Industry
  • Training Personnel
  • Document Control Personnel
  • Regulatory Personnel


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA 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 includes training for Society of Quality Assurance.

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.




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