The Importance of Risk Assessment and Management on Compliance Strategy and Decisions Related to Computer System Validation

Date	Oct 31, 2013
Time	01:00 PM EDT
Cost	$229.00
Online

Course Description: The Webinar will discuss the importance of performing a complete risk assessment as part of any computer system validation effort.  Regulatory agencies fully expect companies to identify each risk up front, in order to demonstrate it has been assessed for likelihood of occurring and severity if it does occur.
Risk management of computer systems in the regulatory environment must be a continuous rather than a discrete process.  When auditing your computer system validation effort, regulatory agencies will expect you to have a risk management plan in place that specifies how you will mitigate each risk associated with a computer system, and how you continue to monitor it.  They will also be looking for metrics that indicate how the system rates in terms of risk at implementation time (baseline), and how ongoing monitoring and action further reduce or eliminate it.

Course Objective: Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization.  With government agencies downsizing staff, there are fewer agents to visit companies and conduct on site audits, and those conducted must be completed in a shorter period of time.

To compensate for this, it is vital that you know the risks associated with each of your systems and have a solid plan for mitigating these and monitoring them over time.  This will expedite the process and reduce the overall time and cost of an audit.  It will also keep the audit and line of questioning within scope, which reduces unnecessary work for both parties.

Improving the quality of documentation in preparation of an audit will result in cost savings and free resources up to work on more pressing company interests.  Preparedness is also a factor in building a more positive relationship with the auditing agency, generating greater trust and cooperation.

Course Outline:

• Describe basic risk assessment and management concepts, explaining the various components and metrics involved
• Discuss how to build a risk management program for the computer systems under regulation
• Apply the risk assessment process to one or more actual computer systems that are typically used in industry (laboratory, clinical, manufacturing)
• Provide an example of the output generated from the risk assessment process
• Provide an example of an organization’s overall risk profile that includes all validated computer systems
• Discuss the presentation of the organization’s computer system risk profile to the regulatory agency 
• Q&A

Target Audience: Information technology analysts, QC/QA managers and analysts, clinical managers and scientists, Analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GMP training specialists and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit.  This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Upon completion of this session, attendees will have an understanding of risk assessment and management concepts, and the guidance needed to develop an internal computer system risk assessment and management program.  They will understand the steps for creating one, along with the key documentation associated with managing the process and presenting results to government agencies.  The attendees will have a good grasp of how to defend their risk approach to computer system validation, and the confidence needed to successfully prepare for and respond to audit questions.