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Clinical Laboratory Incident Management Plan - GLP and FDA Compliance
Tuesday, February 26, 2013 from 10:00 AM to 11:00 AM (PST)
Palo Alto, CA
This Good Laboratory Practices (GLP) training will help attendees to develop laboratory incident management plan in order to ensure that their laboratory practices are FDA GLP compliant and patients, staff and visitors are protected from unexpected events and accidents.
Approximately 60% to 80% of the information a physician uses to diagnose and treat patients comes from Clinical and Anatomic Laboratories. This information needs to be timely and as accurate as possible and when potential incidents do arise, a well-defined incident management plan is needed. A well developed and maintained plan can prevent serious legal consequences as well.
This session will guide attendees through the Good Laboratory Practices (GLP) in the development and maintenance of your laboratory's incident management plan. It will discuss how the laboratory’s incident management plan can play a major role in investigating and reducing potential issues. Following topics will be discussed during the webinar:
· - Definitions of Incident Management
· - Review of the history of “medical errors” leading up to the Incident Management requirements
· - Explain the two main kinds of incidents that need to be investigated
· - Show where the Quality Management Plan can aid in identifying potential incidents
· - What policies and procedures make up the Incident Management Plan
· - How incidents are identified
· - How to conduct and document a “True Cause Analysis” of the incident
· - Developing processes to reduce or eliminate future re-occurrences of previous incidents
· - How to work to foresee future potential incidents
· - Maintaining appropriate documentation and reports for Hospital Administration
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.