Regulatory Affairs Assessment #2

Equipment surfaces which contact components and process materials or drug products shall not be:

Reactive

Additive

Absorptive

All of the above

What does FIFO mean?

Fly In Fly Out

Fade In Fade Out

First In First Out

Field Inspection Field Office

Operations relating to manufacturing, processing, and packaging of Penicillin shall be performed in separate facilities.

True

False

Each container of a pharma component dispensed to manufacturing shall be examined by a second person to assure that:

The color of the component is appropriate

The drug product smells appropriate

The containers are properly identified

All of the above

All excess drug product labeling bearing lot or control numbers shall be retained for 1 year after the expiration date of the batch.

True

False

GMP for drug manufacturers include all of the following except:

Processing cost estimates

Batch release process

End process sampling controls

Equipment maintenance procedures

21 CFR 211 contains the maximum requirements for drug and biologic cGMPs

True

False

In order to be considered a qualified employee of a drug or biologic cGMP company, you must have the appropriate:

Education

Training

Experience

All of the above

OTC drug labeling is exempt from expiration dating requirements if which of the following are true:

A) Labeling does not contain dosage limits

B) A drug is stable for at least 3 years as supported by the stability data

A and B are both true

None of the above

Which of the following are true related to drug reserve sample requirements?

Reserve samples should be kept for both active ingredients and drug products

Reserve samples should consist of at least twice the quantity necessary for all tests

Reserve samples should be retained for a period of 1 year after the expiration date

All of the above

The person specifically mentioned in the QSR is:

Quality Auditor

Design Control Engineer

Management Representative

Complaint Manager

What is a compilation of records which describes the design history of a finished device

Design Control File

Device Master Record

Device History Record

Design History File

During the QSR lecture, the lecture provided an analogy to help you remember the difference between a DMR and a DHR. What was this analogy?

The DHR is like a recipe on how to make the medical device and the DMR is the evidence that you followed the recipe

The DMR is like a recipe on how to make the medical device and the DHR is the evidence that you followed the recipe

The DMR is like a blueprint on how to build a medical device and the DHR is the medical device itself

The DHR is like a blueprint on how to build a medical device and the DMR is the medical device itself

Which is considered a type of design input?

DMR

Validation Data

User Needs Market Survey Results

Product Labeling

Compliance to the QSRs can help a medical device company do the following:

Reduce costs while meeting schedules

Reduce confusion and improve consistency

Reduce product liability exposures like recalls

All of the above

What is the QSRs minimum length of time required for records to be retained?

At least 2 years from the date of release from commercial distribution by the manufacturer

At least 15 years from the date of release from commercial distribution by the manufacturer

As determined by the manufacturer

At least 7 years from the date of release from commercial distribution by the manufacturer

21 CFR 820 contains the minimum requirements for device quality systems.

True

False

When the term "establish" shows up in the QSR, it means define, document, and implement.

True

False

Per the QSR, quality audits are intended to determine what?

How much an employee should be paid

When FDA is likely to conduct an inspection

That the procedures are suitable to achieve quality system objectives

When the company should be sold to a competitor

The term "validation" in the QSR is defined as the means by which the sales price of a device can be determined.

True

False

Which scenario below is an example of courage, per the RAPS code of ethics?

Never ask for advice or help

Provide information about risks if advice is overruled or ignored

Do not admit to mistakes

Hide bad news from upper management

Which scenario below is an example of respect, per the RAPS code of ethics?

Listen to others in a fair and objective way

Refrain from embarrassing others

Create a positive environment

All of the above

Which scenario below is an example of integrity, per the ACRP/APPI code of ethics?

When faced with the potential for a personal liability at work, destroy any evidence of your involvement in the issue

If the data from a clinical study does not confirm the endpoints you originally determined would be easy to accomplish, but you know the reason for this is an administrative error, is OK to change the data to match what you think is correct

If you made an honest mistake in the presentation of clinical data to management, it is OK to blame a less-experienced subordinate for this mistake because it will be a good learning experience for them

You should always accurately represent your own qualifications, education, experience, competence, and affiliations in all spoken, written, or printed communications

Per the ACRP/APPI code of ethics, you should avoid dual relationships that could impair professional judgement or increase the risk of harm to others.

True

False

Treatment is not the same as investigation.

True

False

What is an FDA inspector required to present prior to the start of an inspection?

A sampling notice (FDA Form 484) and their credentials

Notice of inspection (FDA Form 482) and their credentials

A list of observations (FDA Form 483) and their credentials

An establishment inspection report and their credentials

FDA can inspect which of the following documents:

Sales data

Financial data

Personal files to review age discrimination

Complaints

Which of the following steps should you not take in response to an FDA Form 483?

Solve the problem

Look at root cause

Reinspect to assure effective implementation in solution

Send a Form 484 in response

Which of the following is an FDA enforcement tool?

Seizure

Injunction

Warning letter

All of the above

It is in your company's best interest to respond to a received FDA Form 483 within 15 working days?

True

False

Which is considered to be an EIR classification category?

Official Action Indicated

Voluntary Action Indicated

Normal Action Indicated

All of the above

A compliance inspection includes:

A) Verify correction of previous deficiencies

B) Quality systems plus 3 other systems

C) Quality systems plus one other system

D) Both A and C

A warning letter is a type of FDA judicial action.

True

False

What is a PAI?

Pre-Approval Inspection

Preliminary Approval Inspection

Potential Approval Identification

Preliminary Action Indicated

An abbreviated inspection includes:

A) Verify correction of previous deficiencies

B) Quality systems plus 3 other systems

C) Quality systems plus one other system

D) Both A and C

During a QSIT inspection, FDA investigators are primarily assessing the state of control related to the manufacturer's compliance to the QSR.

True

False

FDA defines a label as that which is affixed to the:

Outer box

Inner box

Immediate container

Shipping package

Which federal agency has both consumer protection and competition jurisdiction?

FDA

FTC

CMS

CDC

Product claims listed on a medical product manufacturer's website is considered labeling by the FDA.

True

False

Which reading level does FDA require for all OTC labeling?

College

Highschool

Kindergarten

7th grade

Which are considered to be post-market requirements?

Establishment registration

Adverse event reporting

Recalls

All of the above

A defective product was released into distribution and has caused temporary patient injuries. The patients were treated in a local hospital and may suffer further reversible medical consequences as a result of the defective product. If this product is recalled from the market, which of the following recall classifications would most-likely be assigned?

Class I

Class II

Class III

Schedule I

A manufacturer is informed that a patient was hospitalized with acute sepsis after treatment with their PMA device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than:

5 working days

15 calendar days

30 calendar days

Annual report

A drug manufacturer is informed through their complaint-handling system that a patient infused with their drug has died and the treating physician believes that the drug is the cause of the patient's death. Death is not listed as a potential side effect of using this drug in the package insert so the manufacturer must file an adverse drug effect report with FDA within:

5 working days

15 calendar days

30 calendar days

Annual report

A vaccine manufacturer should use the Vaccine Adverse Event Reporting System (VAERS) to report vaccine adverse events to FDA.

True

False

User facilities must report device-related deaths to FDA and the device manufacturer within 10 working days.

True

False

When exporting an IDE approved device, not approved for marketing in the U.S., you should follow which regulation to export this device to a non-listed country?

801(d)(3)

801(e)(1)

801(e)(2)

802

Which agency shares medical product import detention power with FDA?

CBP

ATF

CDC

FTC

Which medical product type had the most imports in the United States in 2021?

Drugs

Medical devices

Biologics

Combination products

What does TPLC mean?

Total Product Lifetime Concept

Technical Product Limitations and Contraindications

Total Product Life Cycle

Totally Perfect Lifetime Committee

What are some of the best practices for placing a medical product on the market?

To verify all FDA labeling changes are implemented in the final product labeling

To communicate post-market study commitments to all employees

To train all customer/public contact employees on product claims and limitations

All of the above

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Regulatory Affairs Assessment #2

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