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Medical Device - Product Development Validation and Regulation - Exam, Exams of Biology

Punjab Agricultural UniversityBiology

Medical Device, Market Authorisation, Analytical Procedure, Procedure for Validating, Pharmaceutical Ingredients, Process Analytical Technology, Microbiological, Regulatory Requirements, Validation Master Plan, Regulated Environment are points from this questions.

Typology: Exams

2011/2012

Uploaded on 11/29/2012

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Ollscoil na hÉireann, Gaillimh
National University of Ireland, Galway
Spring Examinations 2007 / 2008
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 N. G. Connelly
Internal Examiner(s) Professor R. N. Butler
Professor M. J. Hynes
Instructions:
Answer any four questions
All question are marked equally
Duration 2 hours
No. of Pages 2
Department(s) Chemistry
Course Co-ordinator(s) Professor Michael J. Hynes
Requirements:
MCQ
Handout
Statistical Tables
Graph Paper
Log Graph Paper
Other Material
pf2

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Download Medical Device - Product Development Validation and Regulation - Exam and more Exams Biology in PDF only on Docsity!

Page 1 of 2

Ollscoil na hÉireann, Gaillimh

National University of Ireland, Galway

Spring Examinations 2007 / 2008

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 N. G. Connelly

Internal Examiner(s) Professor R. N. Butler

Professor M. J. Hynes

Instructions: Answer any four questions

All question are marked equally

Duration 2 hours

No. of Pages 2

Department(s) Chemistry

Course Co-ordinator(s) Professor Michael J. Hynes

Requirements :

MCQ

Handout

Statistical Tables

Graph Paper

Log Graph Paper

Other Material

Page 2 of 2

  1. Compare the procedures for obtaining market authorisation (MA) for a combination medical device in the EU and the US. Assess the advantages and disadvantages of the procedures. [25 marks]
  2. Answer both parts (a) and (b)

(a) Briefly outline the classification system used for medical devices. [10 marks]. (b) Annex 1 of the Medical Device Directive (COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices) lays down eight requirements for the design of medical devices. Write brief accounts of five of these. [15 marks].

  1. Irrespective of whether one is dealing with a pharmachem, biopharma, medical device or food production organisation, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) of equipment and instruments is a vital link in the quality chain. Outline the various steps required to qualify equipment before it can be used in, or during, the manufacturing process in a regulated environment. [25 marks]
  2. Discuss the importance of having a Validation Master Plan (VMP) and describe how it can assist in maintaining compliance with regulatory requirements. [25 marks]
  3. It is important to note that the term analytical in Process Analytical Technology (PAT) is viewed broadly to include chemical, physical, microbiological, mathematical, and risk analysis conducted in an integrated manner. Discuss the veracity of this statement in the context of the manufacture of active pharmaceutical ingredients and medical devices. [25 marks]
  4. Describe the procedure for validating an analytical procedure. [25 marks]