Free RAC-GS Exam Braindumps (page: 2)

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In order to develop a global drug product, what is the MOST important environmental characteristic to consider in the country of intended use?

  1. Product stability
  2. Product registration
  3. Product formulation
  4. Product requirements

Answer(s): A



Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

  1. Utilize the STED template to complete global requirements.
  2. Initiate a global submission process after all submission data are finalized.
  3. Identify countries where special requirements exist during the product development phase.
  4. Plan regulatory approval update meetings with senior management and stakeholders.

Answer(s): C



Which term does NOT describe the same concept as the others?

  1. Biosimilars
  2. Follow-on protein products
  3. Monoclonal antibody
  4. Subsequent entry biologics

Answer(s): C



A process is ultimately validated to ensure which of the following?

  1. The process meets the regulatory requirements.
  2. The process meets the quality system requirements.
  3. The process consistently produces the desired results.
  4. The process consistently meets the desiredQuantity standards

Answer(s): C



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Raymond commented on May 02, 2022
Best way to cheat your exam. hahaha... all questions are in this dexam dump.
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