Audit and Inspection Process
What type of documentation is at the top of the documentation hierarchy?
quality policy
Voluntary recalls of products subject to FDA jurisdiction
What is the standard date format for labels?
YYYY-MM-DD
What does GLP stand for?
Good Laboratory Practices
Checklists should be provided to the auditee, especially prior to performing external audits, so the auditee can
b. Gather supporting documentation prior the audit
Checklists should include __ - _____ questions and avoid ____ questions.
open-ended; yes/no
What regulation provides and defines the FDA's control over medical devices and electronic radiation-emitting products?
FD&C Act (Food Drug & Cosmetic Act)
In the device UDI, name one piece of information that the PI must identify
Lot/batch #, serial #, expiration date, date of manufacture, distinct ID code for HCT/P
In the context of 21 CFR Part 803, MDR stands for...
Medical Device Reporting regulation
The tracing technique - that is, selecting an item or a document, and then tracking either forward or back - is often used to aid in sample selection during an audit. Which of the following is an advantage of this technique?
b. Assists the auditor to understand the process flow
What is the most frequently used auditing method?
Random selection
What are the 3 things each signed electronic record should contain?
1. Name of signer
2. Date and time of signing
3. Meaning of signature (e.g. role/department of signer)
What type of studies does Part 58 NOT apply to?
Studies using human subjects or specimens, clinical studies or field trials in animals
Define "test system"
Any animal, plant, microorganism or subparts thereof to which the test or control article is administered
Audit working papers include plans, flowcharts, checklists and report forms. Their primary purpose is to
c. Provide data to support the audit report
Name and describe the 2 tracing methods for auditing
Trace forward - beginning to end, moving from a point to another (can be to completion)
Trace backward - starts at end and works back through the process to the beginning or designated point
Name one kind of combination product (method of combination to be considered a combination product)
1. 2+ regulated components
2. 2+ separate products packaged together in a single package
3. Product packaged separately intended to be used only with another approved product where both are required to achieve intended use
What are the 2 conditions for submitting an event to the FDA required?
When the manufacturer receives or becomes aware of information reasonably suggesting a marketed device
1) caused or contributed to serious injury or death
2) malfunctioned, which is likely to cause or contribute to death if it were to recur
Define "Adequate directions for use"
Directions under which a layman can use a device safely and for the intended use
Which of the following sampling techniques would be used in a quality audit
List the types of data collection methods
1. Interviews
2. Observations
3. Record and document reviews
4. Statistical and non-statistical sampling
What are 3 examples of actions the FDA recommends to prepare for voluntary recalls?
1. Identify appropriate personnel
2. Training personnel on responsibilities
3. Establish recall communication plan
4. Identify reporting requirements for products
5. Use adequate product coding
6. Maintain distribution records
What are the 3 things required to be included on OTC device labels?
1. Statement of identify of the commodity as a principle feature
2. Declaration of net quantity of contents
3. Warnings if containing or manufactured with a Class I substance
A manufacturer is defined by the following activities (name at least 3)
manufacturing, preparing, propagating, compounding, assembling, repackaging, relabeling, processing or identifying specifications for a device
Which of the following statements regarding scoring and nonscoring checklists is valid?
a. Nonscoring checklists are never tallied