Risk Management of cGXP Computerized Systems

Overview:

Quality Risk Management is the approach followed for computerised system validation. Also, as per EU guidelines, Risk management should be applied throughout the lifecycle of the computerized system taking into account patient safety, data integrity and product quality. 

As part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerized system.

Further as FDA recommend that you base your approach on a justified and documented risk assessment and a determination of the potential of the system to affect product quality and safety, and record integrity.

Due to these requirements, this training program is organized to make you understand and implement the requirements to achieve compliance.

Why you should Attend:

The learning objectives are firstly understand the Quality Risk Management and its scope in computerised systems. 

How Pharmaceutical organisation personnel can ensure compliance and be able to comply the requirements. 

The benefits are - 

• The person’s understanding about quality risk management will be clear
• The person working in pharmaceutical will become vigilant while performing QRM of computerized systems
• The person will get practical insight about the topic

Areas Covered in the Session:

The major points covered include;

• Importance of topic
• Purpose and Scope of CSV
• QRM - Guideline Requirements in Computerised Systems
• Quality Risk Management - Overview
• Quality Risk Management - Practical Approach
• Risk Management to Evaluate Potential Impact
• Risk Management within the Validation Lifecycle

Who Will Benefit:

• Quality Assurance
• Quality Control
• Pharmaceutical IT Compliance
• Qlobal QA
• Corporate QA and QC
• IT personnel working or related to pharma IT support