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Pharmaceutical
Inspectorate Curriculum
Module 1 –
Regulating Pharmaceutical Quality and the Relationship to FDA’s
Mission
Objective –
Accurately explain the philosophy
behind why we regulate pharmaceutical quality and how pharmaceutical
quality relates to FDA’s mission.
Module 2 – Risk
Management
Objectives
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Identify current concepts of risk management as they relate to
product quality and discuss the relationship between this knowledge
and how it would be applied during inspections.
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Conduct critical evaluation of GMP violations to determine level of
their impact and their affect on the firm's state of control.
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Discuss how Investigators should strategize to determine product
risk as it applies to inspectional approach and case development.
Module 3 –
Advanced Quality Systems
Objective
– Accurately explain advanced modern quality management techniques,
including implementation of quality systems approaches to all aspects
of pharmaceutical production and quality assurance and how this would
enhance the quality of inspections of pharmaceutical facilities.
Module 4 –
Pharmaceutical Science
Objectives
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Describe the science underlying the approaches to both controlling
product quality and causes of variability and explain how this would
enhance the quality of inspections of pharmaceutical facilities.
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Demonstrate a comprehension of the concerns those Center reviewers
and Center case managers have in their review of applications/cases,
according to pre-determined expectations provided by the Center
divisions.
Module 5 –
Current Regulatory Programs and Procedures
Objectives
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Describe the integration of the review program and inspectional
program as they relate to each other regarding product quality.
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Through a case study, demonstrate effective use of "critical
thinking" and "inspectional discretion" in the evaluation of GMP
violations to determine the level of impact.
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Through a case study, demonstrate effective communication of complex
product quality issues to an agency/industry audience.
Module 6 –
Technology
Objectives
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Demonstrate a comprehension of science and technology advances used
in pharmaceutical manufacturing processes.
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Explain the value of the science and technology advances and how
these advances would enhance the quality of inspections of
pharmaceutical facilities.
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Explain why knowledge of science and technology advances used in
pharmaceutical manufacturing processes will result in inspections
being conducted in a highly effective and consistent manner.
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Explain how exposure to a ‘new’ advanced science or technology
(un-encountered prior to that inspection) could/should alter the
investigator’s inspectional approach.
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Discuss the best practices and compliance issues.
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Explain common and unique problems that may occur using the
technology.
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Identify technological developments that may impact future
production decisions.
Module 7 –
Investigational
Objectives
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Identify situation(s) when the investigator would determine that
he/she needs to learn more about a particular topic .
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Provide a list of possible sources where the investigator could seek
necessary training on a topic for which he/she is not knowledgeable.
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Identify inspectional technique differences between inspections of
firms that manufacture CDER, CVM, and CBER regulated drug products.
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GMP Final Report
Date created: September 29, 2004  |
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