A Low Cost, Seven-Step Approach to Reducing FDA Enforcement Risk
August… Summer… Sun, sand and surf… As the song goes: “summertime and the living is easy…” My hope is that all of you involved in q...
Training Solutions
FDA Consultants provides both on-site and webinar, customized personnel and management training for the FDA regulated industry both in the United States and abroad.
Our Training solutions are tailored to your company’s specific needs. We can provide on-site interactive training in the following areas:
» Quality Assurance
» Quality Control
» Regulatory Affairs
» Manufacturing
» Compliance
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Medical Device/IVD Training Courses |
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1) Quality System Regulation (QSR)/CGMPs for Medical Devices |
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2) Quality
System Inspection Technique (QSIT) and Your Internal |
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3) Preparing and Managing FDA Inspections |
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4) Writing
Effective 483 Responses and Executing Corrective |
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5) Design Controls |
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6) FDA
System-Based Inspections For Drug Manufacturers and |
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7) FDA System-Based Inspections and Your Internal Auditing Program |
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8) Handling
Out-of-Specification (OOS) Investigation and Properly |
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9) Managing
cGMP Formal Failure Investigations and the Closed |
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10) Pre-Approval Inspection (PAI) Preparedness |
We look forward to speaking with you about your specific project needs. Please use the Contact Us form so we can assign the right expertise for further discussion or for an immediate response call 800 782 0580.