Please choose one answer from each questions.

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1. MDSAP Quality Management System Manual was developed with the intent of creating a single audit program that allows a single regulatory audit conducted by a recognized auditing organization to satisfy the needs of multiple jurisdictions.

(a) True

(b) False

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2. According to 21 CFR 820.40(d) finished devicesMUSTbe held in quarantine or otherwise adequately controlled until released.

(a) True

(b) False

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3. Quality system regulations require that a pharmaceutical manufacturer have a policy detailing management and executive responsibilities in the organization's quality system.

(a) True

(b) False

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4. FDA Form 1572, Statement of the Investigator, must include the name and contact information for:

(a) Investigator

(b) Study Coordinator(s)

(c) IRB of record

(d) A and B

(e) A and C

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5. According MDSAP, Level 1 of the Quality Management System includes the Quality Manual

(a) True

(b) False

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6. The Investigator must submit Form FDA 1572 to the FDA.

(a) True

(b) False

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7. Performance indicators are measurable values used to quantify quality objectives.

(a) True

(b) False

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8. A Unique Device Identifier (UDI) is a mandatory, fixed portion of a device label.

(a) True

(b) False

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9. A example of inappropriate delegation of a task by the investigator would be to assign study coordinator to conduct physical exams for the study study subjects,

(a) True

(b) False

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10. As demonstrated in the midterm assignment, communication processes should be efficient and clear. It should ensure theflow of appropriate information between all levels of the company.

(a) True

(b) False

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Please describe in detail.

11. What is one element of quality where your knowledge can be grown?

_________________________________________________________

Please describe in detail.

12. What is the purpose of an SOP from the PERSPECTIVE of the site that uses the SOP?

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