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| Course Information |
Course Schedule |
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Laboratory Compliance Workshop
| $2,400(USD) |
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R1844A |
Four Days |
Workshop |
| $2,784(CAD) |
| Description: |
An interactive workshop using a risk based approach that provides the fundamentals for achieving and sustaining
a cGMP compliant laboratory as well as the tools to assess the state of compliance and potential risks. |
| Outline: |
- Day One
- I. Introduction and Workshop Objectives
- II. History of the Good Manufacturing Practices (GMPs)
- III. GMPs/GxPs
- A. Similarities and Differences
- IV. Regulatory Expectation
- V. Laboratory Operation Process Improvement
- VI. Standard Operating Procedures
- VII. Audits
- A.Types of audits
- B.Preparing for an Audit
- C.Facilitating the audit
- Day Two
- I. Laboratory Operation Key Elements
- A.Sample Management
- - Ensuring Sample Integrity
- B.Laboratory Equipment/Instrumentation
- - Calibration and Maintenance
- C.Reference Standards
- - Qualification
- D.Reagents and Solutions
- E.Stability
- Day Three
- I. Microbiology and Other Laboratories
- II. Training
- III. Analytical Method Validation
- A. Validation Characteristics
- IV. Technical Transfer
- Day Four
- I. Documentation
- A. Documentation Practices
- - Laboratory Notebook Documentation
- B. Data Handling
- - Reprocessing of Electronic Data
- - Document Control
- - Backup/Recovery/Storage
- II. Laboratory Investigations
- A. Handling of Out of Specification Test Results/Unplanned Laboratory Deviations
- - Root Cause Analysis
- - The Investigation and Investigation Report
- III. Roundtable Discussion
- Breakout Sessions
- Exercises are included throughout the 4-day session.
- I. Mock Audit
- A. Interaction with Agencies and Clients
- B. How to Handle Inspections and Audits
- II. Quality System Assessment/Remediation Plan
- III. Analytical Method Validation
- A. Qualification versus Validation
- B. Protocol
- - Identify key elements and acceptance criteria
- IV. Laboratory Investigation
- A. Root Cause Analysis
- B. Raw Data
- V. Reagents/Solutions/Media
- VI. Instrumentation and Equipment
- A. Analyst Responsibility
- B. Daily Use/Maintenance Logs
- C. Preventive Maintenance
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| Prerequisites: |
None. |
| Equipment: |
None. |
| Student Profile: |
Personnel interested in assuring compliance within the laboratory or with overall responsibility for
Laboratory Compliance.
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| Course Calendar: | On Demand |
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