Bcps regulatory Study guides, Class notes & Summaries

BCPS – Regulatory | latest 2023/24 FDA office of commissioner - top office senate confirmation overall agency coordination FDA office of chief counsel - legal affairs FDA office of regulatory affairs - largest office all inspection and enforcement center for drug eval and research - CDER regulates rx and non rx drugs ANDA - abbreviated NDA submit to CDER review and ultimate approval of a generic product authorized generic drug - marketed sold or distributed directly or i...

BCPS – Regulatory QUESTIONS WITH COMPLETE SOLUTIONS

nuity planning process, which of the following should be identified FIRST in the business impact analysis? Critical business processes for ascertaining the priority for recovery. Which of the following disaster recovery/continuity plan components provides the GREATEST assurance of recovery after a disaster? The alternate facility will be available until the original information processing facility is restored. There are several methods of providing telecommunications continuity. ...

BCPS – Regulatory Exam Questions And Answers All Correct FDA office of commissioner - CORRECT ANSWERS top office senate confirmation overall agency coordination FDA office of chief counsel - CORRECT ANSWERS legal affairs FDA office of regulatory affairs - CORRECT ANSWERS largest office all inspection and enforcement center for drug eval and research - CORRECT ANSWERS CDER regulates rx a...

BCPS - Regulatory

SRP stages - ANSWERS-emergency stage -alternative marketing stage -contingency production stage -communication stage strategic redeployment plan - ANSWERSdetermines how to resume operations in a way that repairs an org's reputation and ensures its recovery and survival; when BCPs fail BCP elements - ANSWERS-time goal -operational goal -resources needed -details tasks and procedures -documentation risk-transfer model - ANSWERSpurchasing BI insurance prioritization model - ANSW...

SRP stages -emergency stage -alternative marketing stage -contingency production stage -communication stage strategic redeployment plan determines how to resume operations in a way that repairs an org's reputation and ensures its recovery and survival; when BCPs fail BCP elements -time goal -operational goal -resources needed -details tasks and procedures -documentation risk-transfer model purchasing BI insurance prioritization model prioritizing which pr...

BCPS – Regulatory correctly answered 2023FDA office of commissioner top office senate confirmation overall agency coordination FDA office of chief counsel legal affairs FDA office of regulatory affairs largest office all inspection and enforcement center for drug eval and research CDER regulates rx and non rx drugs ANDA abbreviated NDA submit to CDER review and ultimate approval of a generic product authorized generic drug marketed sold or dis...