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Deviation Reporting System
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Guidance for Manufacturing of Biological APIs for Use in Trials
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Guidance on Audit Report Confidentiality
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Batch Record Review
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Gowning Requirements
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GMP Protocols and Reports
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Creation of Installation Qualification Protocols
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Third Party Change Control Oversight
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Interpretation of 21 CFR Part 11
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Batch Record Review Checklist Template/Example
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Master Batch Records and Batch Record Issuance
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Quality Assurance Disposition Process
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Audits and Reports
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Creation of Operational Qualification Protocols
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Customer Complaint Processing
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Corrective and Preventative Actions (CAPA)
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26
Deviation Reporting System
1 x
$
39.95
Creation of Performance Qualification Protocols
1 x
$
49.95
Medical Device Reporting
1 x
$
39.95
Vendor and Contractor Operation Qualification
1 x
$
39.95
Guidance for Manufacturing of Biological APIs for Use in Trials
1 x
$
59.95
Guidance on Audit Report Confidentiality
1 x
$
39.95
Batch Record Review
1 x
$
39.95
Post Marketing Surveillance / Recalls
1 x
$
39.95
Creation of Logs and Logbooks
1 x
$
29.95
Corporate QA Audits
1 x
$
39.95
Creation of Item Specifications
1 x
$
39.95
Document Change Control
1 x
$
39.95
Gowning Requirements
1 x
$
49.95
GMP Protocols and Reports
1 x
$
39.95
Creation of Installation Qualification Protocols
1 x
$
49.95
Third Party Change Control Oversight
1 x
$
39.95
Interpretation of 21 CFR Part 11
1 x
$
59.95
Batch Record Review Checklist Template/Example
1 x
$
4.95
Master Batch Records and Batch Record Issuance
1 x
$
39.95
Quality Assurance Disposition Process
1 x
$
39.95
Audits and Reports
1 x
$
39.95
Creation of Operational Qualification Protocols
1 x
$
49.95
Customer Complaint Processing
1 x
$
39.95
Corrective and Preventative Actions (CAPA)
1 x
$
49.95
Personnel Qualifications
1 x
$
39.95
QA Hold System
1 x
$
39.95
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Deviation Reporting System
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Risk Analysis
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Certificate of Analysis Package
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Batch Record Review Checklist Template/Example
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