Risk Based Incident Management and CAPA for GxP Computerized Systems Operations

Recognizing that the control of the resolution and implementation of the correction may be managed by other processes.

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This 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.

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).

corrective action capa

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).

 

  • 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

 

  • 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

Risk Management for Operational Processes http://bit.ly/2UmYyIt

 

 

 

Investigators to Review CAPA and What you Should do to Prepare

How your company can use that same document to increase the likelihood of a positive outcome during the inspection.

Fremont, CA: Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a webinar on January 11, 2019. The topic of the webinar is “How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare”, and the speaker is Jeff Kasoff

To enroll for this webinar, please visit https://www.compliance4all.com/control/w_product/~product_id=502272LIVE?LI-SEO

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Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company’s CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.

  • Documents Used by FDA Inspectors
  • Investigations Operations Manual (IOM)
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • CPG Manual 7382.845
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • QSIT Manual
    • Description of each CAPA Inspectional Objective
    • Recommended Methods of Compliance

Positive outcome during the inspection http://bit.ly/2CUFWK8