3-Hour Virtual Seminar on Risk Based Incident Management and CAPA for GxP Computerized Systems Operations

Thursday, January 31, 2019   |   12:00 PM PST | 03:00 PM EST   |   Duration: 3 Hours      


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Duration: 3 Hours  


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We will complete the webinar by discussing about the Incident Management, Incident Management process is intended to provide effective support for unexpected events to users of laboratory, process control, and IT systems.
Angela Bazigos   Product Id : 502257
  Instructor : Angela Bazigos

  More Trainings by this Expert


This Webinar specifically addresses the Incident Management and CAPA processes 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: An incident is any unplanned occurrence which prevents (or may prevent) or delays users, the system, an operation, or a service from proceeding with an assigned task. The Incident Management process is intended to provide effective support for unexpected events to users of laboratory, process control, and IT systems.

The CAPA process captures those incidents and failures escalated from the incident management and periodic review processes. These are then tracked from initial occurrence, through impact assessment to resolution and implementation of the correction, recognizing that the control of the resolution and implementation of the correction may be managed by other processes.

The CAPA process also accommodates the situation in which a failure needs both corrective action (to fix a failure) and additional preventive action (to avoid the failure occurring again).

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


SESSION 2: Incident Management
  • Introduction
  • Roles and Responsibilities
  • Incident Logging
  • Incident Evaluation & Categorization
  • Incident Escalation
  • Incident to CAPA (see next process)
  • Incident Resolution
  • Training
  • Incident Closeout
  • Periodic Review
  • Records and Record Content
  • Scalability
  • Related Processes


SESSION 3: Corrective and Preventive Action (CAPA)
  • Introduction
  • Roles and Responsibilities
  • Sources of CAPA
  • CAPA Log Entry
  • Root Cause Analysis
  • CAPA Priority and Rigor of Control
  • CAPA Resolution
  • CAPA Closure
  • Periodic Review Considerations
  • Records and Record Content
  • Scalability
  • Related Processes

Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, Biologics, Food, Veterinary, Laboratory Tobacco, Tissue and Blood fields. The employees who will benefit include:
  • 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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