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Biomedical Science Product Development & Regulation Exam Info, NUIG 2009-2010, Exams of Biology

Details about an exam for the m.sc. Biomedical science module bes515 at the national university of ireland, galway, during the spring examinations of 2009-2010. The exam covers topics related to product development, validation, and regulation. It includes information about the exam code, modules, paper number, duration, departments, course coordinators, and instructions. Questions include topics on manufacturing regulations, validation master plans, process analytical technology, cleaning validation, regulatory processes for combination products, and definitions of medical devices.

Typology: Exams

2011/2012

Uploaded on 11/29/2012

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Ollscoil na hÉireann, Gaillimh
National University of Ireland, Galway
Spring Examinations 2009 / 2010
Exam Code(s) 1MV1
Exam(s) M.Sc. Biomedical Science
Module Code(s) BES515
Module(s) Product Development, Validation and Regulation
Paper No. 1
Repeat Paper
External Examiner(s) Professor K. Molloy
Internal Examiner(s) Professor P. V. Murphy
Professor L. Eriksson
Dr. Leigh Jones
Instructions:
Answer any three questions
All question are marked equally
Duration 2 hours
No. of Pages 2
Department(s) Chemistry
Course Co-ordinator(s) Dr. Niall Geraghty
Requirements:
MCQ
Handout
Statistical Tables
Graph Paper
Log Graph Paper
Other Material
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Page 1 of 2

Ollscoil na hÉireann, Gaillimh

National University of Ireland, Galway

Spring Examinations 2009 / 2010

Exam Code(s) 1MV

Exam(s) M.Sc. Biomedical Science

Module Code(s) BES

Module(s) Product Development, Validation and Regulation

Paper No. 1 Repeat Paper

External Examiner(s) Professor K. Molloy Internal Examiner(s) Professor P. V. Murphy Professor L. Eriksson Dr. Leigh Jones Instructions: Answer any three questions All question are marked equally Duration 2 hours No. of Pages 2 Department(s) Chemistry Course Co-ordinator(s) Dr. Niall Geraghty

Requirements : MCQ Handout Statistical Tables Graph Paper Log Graph Paper Other Material

Page 2 of 2

1. Answer all parts (a) With respect to manufacturing regulations, briefly describe what is meant by the term validation and discuss its origin and aims. [17 marks] (b) Manufacturers in the food and drug industries are not required by law to possess a Validation Master Plan (VMP) however the majority will have produced such a document. Discuss the advantages for creating such a dossier. [ 17 marks] 2. Discuss what is meant by the term Process Analytical Technology (PAT) and describe its origin and objectives. **[34 marks]

  1. Answer all parts** Discuss cleaning validation under the following headings: (a) Equipment to be cleaned [7 marks] (b) Personnel responsibilities [7 marks] (c) Sampling methods [7 marks] (d) Record keeping [7 marks] (e) Establishment of limits [6 marks] 4. Outline the regulatory processes involved in having a combination product (device
  • pharmaceutical) approved in the USA. [34 marks] 5. Give 5 examples of medical devices. How is a medical device defined in the EU? [34 marks]