The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Compliance Program Chapter 41 - Therapeutic Products Inspection of Tissue Establishments 7341.002A
Origin/Publisher:
Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/CompliancePrograms/UCM238872.pdf
Document Type:
Guidance Manual
Content:
Compliance Program CBER Biologics
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
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- Regulatory Affairs
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- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
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- Impurities
- OOS / OOE / OOT
- Material Testing
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- Analytical Instrument Qualification
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- Technology
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- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others