The Webinar will discuss the importance of performing a thorough, yet cost-effec
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| Description: | Industry: Biotechnology , FDA Regulated Industries , Medical Device , Pharmaceutical Speaker: Carolyn Troiano DESCRIPTION The Webinar will discuss the importance of performing a thorough, yet cost-effective computer system validation effort. Regulatory agencies fully expect companies to identify each risk up front, in order to demonstrate they have all been assessed for the likelihood of occurrence and severity of impact. 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 mitigate or eliminate it. Along with risk assessment, categorizing your system according to GAMP 5 guidelines will enable you to develop the most cost effective approach to computer system validation without sacrificing compliance. We will share some cases from industry that demonstrate how developing this type of strategic approach r reduces the total cost of validation while ensuring maximum compliance. Why should you attend : 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. Assessing the risk and categorizing you system according to GAMP 5 guidelines will enable you to develop a strategic approach to computer system validation that will meet FDA compliance. As cost is a significant factor in any system implementation and validation effort, you will learn about ways to lower those costs without sacrificing compliance. 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. As mergers and acquisitions continue within the FDA-regulated industries, it is also vital to develop a strategy based on how much risk your operation is willing to tolerate. Merging organizations that do not share a common philosophy will result in confusion and may mean that employees will leave, rather than change their ethical beliefs. Areas Covered in the Session: - Provide an overview of FDA oversight and compliance objectives - Provide an overview of Computer System Validation (CSV) and the System Development Life Cycle (SDLC) approach used as a framework for conducting CSV activities - Describe basic risk assessment and management concepts, explaining the various components and metrics involved - Explain GAMP 5 system classification and how to apply it when developing a CSV approach - Develop the ability to apply the SDLC when validating computer systems in your organization - Understand the best practices for maintaining a computer system in a validated state - Discuss the best practices necessary to ensure all systems are validated appropriately - Provide an overview and details of the process for validating a computer system such that cost is minimized while compliance is maximized CSV activities - Apply the strategic approach to CSV 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 process of developing a CSV strategic approach - Discuss the presentation of the organization’s CSV strategy and rationale to the regulatory agency CSV activities Provide an overview of trends in FDA compliance related to CSV strategic planning, focusing on recent findings and how to avoid these - Q&A Who will benefit: (Titles) Information Technology Analysts Information Technology Developers and Testers QC/QA Managers and Analysts Clinical Data Managers and Scientists Analytical Chemists Laboratory Managers Automation Analysts Computer System Validation Specialists GMP Training Specialists Business Stakeholders/Subject Matter Experts Business System/Application Testers This webinar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance. Webinar includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 90 Minutes Live Presentation Certificate of attendance |
| URL: | https://www.compliance2go.com/product/?topic=fda-computer-systems |
| Date: | Tuesday, April 19, 2016 |
| Access: | Public |
| Category: | Education* |
| Created by: | Public Access |
| Updated: | Tuesday, April 12, 2016 4:24am UTC |
| : | $179 |
| : | (877) 782-4696 |
| : | subscribe@compliance2go.com |
| : | David |
| : | (877) 782-4696 |
| Comments: | None |