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How to Protect Quality Incident Record

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Good morning, I'm Connie McLaughlin, welcoming you to today's webinar on unusual incident investigation. Joining me are Cathy Blind, Regional Manager from the Ohio Department of Developmental Disabilities, and Scott Phillips, Assistant Deputy Director from the same department. Before we begin, I want to cover some housekeeping items: all participants logged in will receive credit for attending today's session. Handouts are available for those who registered before yesterday's deadline. These materials will also be accessible on the Ohio Department of Developmental Disabilities website, specifically in the health and safety toolkit, with some posted in the GoToWebinar system for download.

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What is incident in quality control?

Lab incident is the Event which may or may not cause deviation(s). Incident is an unexpected/unplanned happening of an event which does not have direct impact on the product or production activity.

What is incident in pharma for QC?

An incidence is an event that can affect our product quality or not but that is against the cGMP. For example, someone is found without gowning in the production area or any insect is found in granulation area. These may have the impact on product quality but not every time, sometimes it will not impact.

What are the five elements of good incident report?

Identifying the how, when, where and whom of the incident are important elements of a good report and all companies are most likely to emphasize these marks during the document development.

What is the definition of a quality incident?

Statistical quality incidents occur when the quality of the data is called into question. This can occur at any stage in the statistical process and should be managed and reported appropriately.

What are the 4 types of incident reports?

Common Types of Incident Reports Workplace. Workplace incident reports detail physical events that happen at work and affect an employees productivity. Accident or First Aid. Safety and Security. Exposure Incident Report.

What is quality incident?

Statistical quality incidents occur when the quality of the data is called into question. This can occur at any stage in the statistical process and should be managed and reported appropriately.

What is incident and deviation?

Deviation is defined as when we are deviating from written procedure or GMP (Good manufacturing practices) document. Incidence is defined as something non cGMP (current Good manufacturing practices) have occurred all of sudden which may or may not have impact on product Quality.

What is incident in quality assurance?

Definition: A laboratory incident shall be defined as unplanned or uncontrolled event in the form of non compliance from the designated system, Instrument or procedure at any stage of analysis due to system failure or instrument malfunction or manual error.

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