Question When would the FDA Design Controls NOT · 2 201 EN1615-10 Question Mention at least two...

Design Control

EN1615-1© Key2Compliance AB 2013

QuestionWhen would the FDA requirement to follow Design Controls NOT be required?

AnswerWhen a Class I device is being developed and the device is not listed in 820.30(a) as a Class I device subjected to Design Controls.

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Design Control


QuestionOne of the below can be considered a well defined Design Input, which? A) The product should be lightweight.B) The product should look good.C) The product needs to be able to pump quickly.D) The battery in the product should have at least 12 months lifetime.

AnswerB

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Design Control


QuestionMention at least two specific expectations of design verification

AnswerCalibrated equipment for measurements, Pre-established acceptance criteria, Approved protocol, Documented results with date, individuals etc.

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Design Control


QuestionIs it an FDA requirement that the Quality Assurance Director of the company signs off on the Design Plan?

AnswerNo, it is up to the company to define those individuals/ functions that are required to sign off on the plan.

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Design Control


QuestionMedical devices containing software are always classified as Class II or III. True or False?

AnswerFalse

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Design Control


QuestionIs there a requirement in the QS regulation that an independent person shall double check results from Design Verification?

AnswerNo

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ManagementControls


QuestionFor how long shall production records be archived in accord-ance with 21 CFR 820?

AnswerA period of time equivalent to the expected lifetime of the device, but no less than 2 years from release.

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ManagementControls


QuestionDo all changes that are handled through the Change Control program in the company have to be submitted to the relevant authorities?

AnswerNo, but changes that affect the Authorizations/Registrations have to be communicated.

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ManagementControls


QuestionAn archive for CGMP/QS documentation shall be protected – against what?

Answer- Unauthorized access - Fire- Flooding (And data loss for documenta-tion in electronic format).

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ManagementControls


QuestionOne of these sentences about Risk Management is correct, which?A) Risk Management contains Risk Assessment, Risk control, Risk Review and Risk Commu-nication.B) Risk Management is only required for high risk devices.

AnswerA is correct.

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ManagementControls


QuestionIs there a CGMP/QS requirement for internal audit frequency?

AnswerNo, but you are expected to set a frequency, which is normally annually.

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ManagementControls


QuestionCan critical components be purchased from a supplier who does not sign an agreement requiring notification of changes?

AnswerYes, but the type of control over that supplier has to be adjusted to this fact.

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Production andProcess Controls


QuestionComplete the following statement: “Process validation is to establish ………... evidence that the process consistently produces product meeting predetermined specifications.”

AnswerObjective

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QuestionHEPA-filters are common in this industry, what does HEPA stand for?

AnswerHigh Efficiency Particulate Air

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QuestionWhat is correct practice if a piece of equipment or an instrument is found to be defective?

AnswerRemove it or clearly label it as defective.

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QuestionWhich of the following is not a requirement for components?:A) The oldest material shall be used first, if the components deteriorates over timeB) Should be purchased from one supplier only

AnswerB is wrong.

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Question Is this a correct description of how process changes shall be treated, yes or no?

“The change is assessed from an efficiency perspective to ensure that only changes which would results in more efficient production are introduced”.

AnswerNo

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QuestionIs it Good Documentation Practice to use pencils so you easier can make corrections if necessary?

AnswerNo, you are expected to use a pen.

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CAPA


QuestionA formal CAPA-system is ex-pected to include monitoring of multiple data sources. Among the following proposals, which source is NOT relevant from a Quality System perspective?A) Audit/inspection results. B) Customer complaints.C) Budget achievement. D) Manufacturing data.

AnswerC

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CAPA


QuestionDo you have to scrap (discard) non-conforming material in medical device manufacturing?

AnswerNo, you may do other things such as rework or re-grade.

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CAPA


QuestionIs it necessary to have a proce-dure for Corrective and Preven-tive Actions if we have shown over the years that we have very low number of deviations?

AnswerYes

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CAPA


QuestionShall each and every audit finding be discussed during Management Review in order to identify needs for Corrective and Preventive Actions?

AnswerNo, it is up to the company to identify the process and proce-dures to escalate issues.

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CAPA


QuestionIs a record keeping mistake something that should be handled as a deviation?

AnswerThis has to be defined in a company procedure and put in relation to the seriousness of the mistake.

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CAPA


QuestionIf adverse events are trended, summarized and reported to Management for review, is it still necessary to report and discuss complaints at Management Review?

AnswerYes. Complaints do also have to be reported since not all complaints may be categorized as adverse events.

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Question When would the FDA Design Controls NOT · 2 201 EN1615-10 Question Mention at least two...

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