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ORA Laboratory Manual		 Document TOC


Volume 3 Laboratory Operations, Applications and Programs



Section 1 Environmental Health and Safety


1.1 Introduction
1.2 Laboratory Safety
1.3 Emergency Response
1.4 Environmental Health (EH)
1.5 Environmental Health & Safety Audit
1.6 Investigations Branch Activities & Safety
1.7 ORA Environmental Health and Safety References

Section 2 Chain of Custody -Sample Handling


2.1 Introduction
2.2 Protection, Storage, and Unique Identification of Samples in the Laboratory
2.3 Custodial Receipt and Storage of Samples
2.4 Receiving Samples from Custodial Storage and Opening the Sample Package
2.5 Intra/Inter Laboratory Splitting and Transferring of Samples
2.6 Preparing Reserve Samples for Storage or Shipment
2.7 Returning Samples to Custodial Storage
2.8 Shipping Samples from the Laboratory
2.9 Disposition of Samples
2.10 References

Section 3 Recording of Results - Analyst's Worksheet


3.1 Introduction
3.2 Recording Analytical Information, Observations and Findings
3.3 Completing Worksheet and Continuation Sheet
3.4 Additional and Check Analysis
3.5 Assembling, Reviewing, and Approving the Analytical Package
3.6 Abbreviated Recording and Reporting of Findings for Surveillance Samples
3.7 Consumer Complaint Letters
3.8 Definitions
3.9 Document/Change History

Section 4 Basic Statistics and Presentation


4.1 Introduction
4.2 General Considerations
4.3 Data Handling and Presentation
4.4 Linear Curve Fitting
4.5 Development and Validation of Spreadsheets for Calculation of Data
4.6 Control Charts
4.7 Statistics Applied to Drug Analysis
4.8 Statistics Applied to Radioactivity
4.9 Statistics Applied to Biological Assays
4.10 Statistics Applied to Microbiological Analysis
4.11 Document History

Section 5 Analysts on Inspection


5.1 Historical Background and the Law
5.2 Analysts on Inspection
5.3 Types of Inspections
5.4 Establishment Inspection Reports
5.5 FDA-483 Objectionable Conditions and Practices
5.6 TurboEIR
5.7 Computerized Systems and Electronic Records
5.8 Helpful References Pages on the Internet or Intranet
5.9 Document/Change History

Section 6 ORA Method Development and Validation Program


6.1 Introduction
6.2 Purpose
6.3 Background and Program Overview
6.4 Roles and Responsibilities
6.5 ORA Method Development and Validation Process
6.6 Scientific Conduct When Performing Research
6.7 Document/Change History
6.8 Appendices

Section 7 Private Laboratory Guidance


7.1 Objective
7.2 Sampling
7.3 Information about the Private Laboratories
7.4 Audit Samples
7.5 On-site Assessment Visits
7.6 Consultations
7.7 Meetings
7.8 Continuing Problems
7.9 Time Reporting
7.10 Requests for Referrals
7.11 Attachments
7.12 Document History

Section 8 Courtroom Testimony


8.1 Introduction
8.2 The Basics
8.3 Giving Testimony
8.4 The Scientific Witness
8.5 General References
8.6 Attachments

 

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