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ORA Laboratory Manual
Introduction
Volume I ORA Laboratory Manual of Quality Policies
Volume II ISO 17025 ORA Laboratory Procedures
Volume III Laboratory Operations, Applicatins and Programs
Volume IV Laboratory Training
Change History
Contact
Search
Science References
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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