During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.

Which of the following is the most appropriate action to take FIRST?

A. Withdraw the affected product from the markets.

B. Send a "Dear Dr." letter to customers.

C. Notify the global regulatory authorities.

D. Assess the potential safety risk.

Which of the following statements regarding export regulations for an approved product is CORRECT?

A. The product must not be in accord with the specifications of the foreign purchaser.

B. The product must not be in conflict with the laws of the country to which it is intended forexport.

C. The product must not be labeled on the outside of the shipping package that it is intendedfor export.

D. The product must not be sold or offered for sale in domestic commerce.

A regulatory affairs professional has submitted a package for regulatory review. According to the regulation, the regulatory authority will need to respond within 90 days of submission. If there is no response after the deadline, what is the BEST approach?

A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.

B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.

C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.

D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.

GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?

A. Instructions for use

B. Risk analysis

C. Product literature

D. Essential principles

A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

A. Concept development and validation

B. Concept development and early technical design

C. Early technical design and product release

D. Product release and validation