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How to Protect Quality Incident Record

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you good morning my name is Connie McLaughlin and Id like to welcome you to todays webinar on unusual incident investigation with me today our Cathy blind regional manager with the Ohio Department of developmental disabilities and Scott Phillips the assistant deputy director from the Ohio Department of Developmental Disabilities mu I a registry unit welcome Cathy Ann Scott no RA so before we get started with todays presentation we wanted to go over a few housekeeping items first of all everyone that is logged on to the computer today will get credit obviously for participating in todays webinar there are handouts available if you registered before yesterday evening you would have received those with an email there were many handouts and we will make those available through they will hire Department developmental disabilities website in the health and safety toolkit some of them are posted here through the go to webinar system so if you havent received those feel free to download

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Got questions?

Below are some common questions from our customers that may provide you with the answer you're looking for. If you can't find an answer to your question, please don't hesitate to reach out to us.

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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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