Science & Research
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Volume III Laboratory Operations, Applications and Programs
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Section 1 Environmental Health and Safety
Volume III - 1.1 Introduction Volume III - 1.2 Laboratory Safety Volume III - 1.3 Emergency Response Volume III - 1.4 Environmental Health (EH) Volume III - 1.5 Environmental Health & Safety Audit Volume III - 1.6 Investigations Branch Activities & Safety Volume III - 1.7 ORA Environmental Health and Safety References Volume III - 1.8 Document Change History
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Section 2 Chain of Custody -Sample Handling
Volume III - 2.1 Introduction Volume III - 2.2 Protection and Storage of Samples in the Laboratory Volume III - 2.3 Custodial Receipt and Storage of Samples Volume III - 2.4 Receiving Samples from Custodial Storage and Opening the Sample Package Volume III - 2.5 Intra/Inter Laboratory Splitting and Transferring of Samples Volume III - 2.6 Reserve Samples Volume III - 2.7 Returning Samples to Custodial Storage Volume III - 2.8 Shipping Samples from the Laboratory Volume III - 2.9 Disposition of Samples Volume III - 2.10 References Volume III - 2.11 Document Change History
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Section 3 Recording of Results - Analyst's Worksheet
Volume III - 3.1 Introduction Volume III - 3.2 Recording Analytical Information, Observations and Findings Volume III - 3.3 Completing Worksheet and Continuation Sheet Volume III - 3.4 Types of Analysis Volume III - 3.5 Assembling, Reviewing, and Approving the Analytical Package Volume III - 3.6 Abbreviated Recording and Reporting of Findings for Surveillance Samples Volume III - 3.7 Consumer Complaint Letters Volume III - 3.8 Definitions Volume III - 3.9 Document Change History
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Section 4 Basic Statistics and Presentation
Volume III - 4.1 Introduction Volume III - 4.2 General Considerations Volume III - 4.3 Data Handling and Presentation Volume III - 4.4 Linear Curve Fitting Volume III - 4.5 Development and Validation of Spreadsheets for Calculation of Data Volume III - 4.6 Control Charts Volume III - 4.7 Statistics Applied to Drug Analysis Volume III - 4.8 Statistics Applied to Radioactivity Volume III - 4.9 Statistics Applied to Biological Assays Volume III - 4.10 Statistics Applied to Microbiological Analysis Volume III - 4.11 Document History
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Section 5 Analysts on Inspection
Volume III - 5.1 Historical Background and the Law Volume III - 5.2 Analysts on Inspection Volume III - 5.3 Types of Inspections Volume III - 5.4 Establishment Inspection Reports Volume III - 5.5 FDA-483 Objectionable Conditions and Practices Volume III - 5.6 TurboEIR Volume III - 5.7 Computerized Systems and Electronic Records Volume III - 5.8 Helpful References Pages on the Internet or Intranet Volume III - 5.9 Document/Change History
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Section 6 ORA Method Development and Validation Program
Volume III - 6.1 Introduction Volume III - 6.2 Purpose Volume III - 6.3 Background and Program Overview Volume III - 6.4 Roles and Responsibilities Volume III - 6.5 ORA Method Development and Validation Process Volume III - 6.6 Scientific Conduct When Performing Research Volume III - 6.7 Document/Change History Volume III - 6.8 Appendices
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Section 7 Private Laboratory Guidance
Volume III - 7.1 Objective Volume III - 7.2 Sampling Volume III - 7.3 Information about the Private Laboratories Volume III - 7.4 Audit Samples Volume III - 7.5 On-site Assessment Visits Volume III - 7.6 Consultations Volume III - 7.7 Meetings Volume III - 7.8 Continuing Problems Volume III - 7.9 Time Reporting Volume III - 7.10 Requests for Referrals Volume III - 7.11 Attachments Volume III - 7.12 Document History
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