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 Inspections of Medical Device Manufacturers
Internet:
Origin/Publisher:
FDA
Document Type:
Compliance Guide
Content:
This guide was prepared to address concerns about consistency and uniformity of inspection between the domestic and foreign inspection programs. Consistency and uniformity of inspection and enforcement represent high priority goals for the Office of Regulatory Affairs (ORA). This guide sets forth clear instructions regarding the approach to the foreign inspection.
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
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- Development
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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
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- General IT Compliance Topics
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- 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
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- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others