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Guidance for Manufacturing of Biological APIs for Use in Trials
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18
Creation of List Documents
1 x
$
29.95
Laboratory Notebook Documentation Guidelines Policy
1 x
$
39.95
Corrective and Preventative Actions (CAPA)
1 x
$
49.95
Deviation Reporting System
1 x
$
39.95
Management Reporting and Quality Review
1 x
$
39.95
Audits and Reports
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$
39.95
Batch Record Review Checklist Template/Example
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$
4.95
Guidance for Manufacturing of Biological APIs for Use in Trials
1 x
$
59.95
Vendor and Contractor Operation Qualification
1 x
$
39.95
Creation of Performance Qualification Protocols
1 x
$
49.95
Creation of Logs and Logbooks
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$
29.95
Technical Change Control
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39.95
Creation of Operational Qualification Protocols
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49.95
Customer Complaint Processing
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39.95
Creation of Item Specifications
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$
39.95
Creation of Installation Qualification Protocols
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$
49.95
Gowning Requirements
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49.95
Creation of Forms
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GMP Procedures (SOPs)
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Gowning Requirements
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Creation of Performance Qualification Protocols
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Creation of Operational Qualification Protocols
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Creation of Installation Qualification Protocols
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Raw Material Receipt and Disposition
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Raw Material Receipt and Disposition
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Post Marketing Surveillance / Recalls
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QA Hold System
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QA Hold System
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Vendor and Contractor Operation Qualification
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Risk Analysis
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Risk Analysis
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Third Party Change Control Oversight
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Third Party Change Control Oversight
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Corporate QA Audits
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Deviation Reporting System
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Medical Device Reporting
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Medical Device Reporting
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Creation of Item Specifications
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Management Reporting and Quality Review
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Quality Assurance Disposition Process
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Quality Assurance Disposition Process
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Batch Record Review
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Batch Record Review
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GMP Protocols and Reports
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GMP Protocols and Reports
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Master Batch Records and Batch Record Issuance
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Master Batch Records and Batch Record Issuance
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