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Course Schedule |
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Preparing for a Laboratory Audit
| $1,200(USD) |
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R1848A |
Two Days |
Workshop |
| $1,392(CAD) |
| Description: |
This workshop provides insight to maintaining a state of readiness in the laboratory by defining the process for preparation,
facilitation and responding to observations and recommendations. |
| Outline: |
- Day One
- I. Introduction and Workshop Objectives
- II. A short history of the Good Manufacturing Practices (GMPs)
- III. Audits
- A. What is an audit?
- B. Laboratory Responsibility
- C. Types of Audits
- - Regulatory
- - Internal
- D. Frequency
- IV. Preparing for an Audit
- A. What to expect?
- B. How to react!
- C. Why are “they” coming?
- D. How to maintain “readiness”
- V. Facilitating the audit
- A. Regulatory Authority Responsibilities
- B. Your Responsibilities
- C. Boundaries
- VI. Being Prepared
- A. Key Areas
- - Local Procedures (SOPs)
- - Sample Management
- - Laboratory Equipment/Analytical Instrumentation
- - Reference Standards, Reagents, and Solutions
- - Analytical Methods
- - Stability Program
- - Training
- - Documentation Practices
- - Handling of Out of Specification Test Results and other laboratory related deviations
- Day Two
- VII. Quality Systems
- A. Overview
- B. Assessment
- C.FDA Approach
- Breakout Sessions
- Exercises are included throughout the 2-day session.
- I. Mock Audit
- a. Internal and External
- II. Preparation for
- a. Pre-work
- III. Close Out Meeting
- a. “Real Time Response
- b. Writing a formal response
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| Prerequisites: |
None. |
| Equipment: |
None. |
| Student Profile: |
Personnel interested in assuring “readiness” for an audit as well as those who are interested in a systematic
approach to preparation and participation in a cGMP audit. |
| Course Calendar: | On Demand |
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