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      Courses #FDA


      ESSENTIAL EU MDR REQUIREMENTS - MINIMIZE THE RISK OF NON-COMPLIANCE

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      3-HOUR VIRTUAL SEMINAR ON 510(K)'S, PMA'S, IDE'S AND DENOVO'S

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      Establishing FDA-Compliant Product Stability Testing Program

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      FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

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      FDA vs Health Canada - Similarities and Differences between the two Regulatory Bodies

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      FDA/ICH Guideline Q9 (R1) On Quality Risk Management

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      3-Hour Virtual Seminar On IEC 62304 - Medical Device Software Compliance

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      Quality in Technology Transfer Projects

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      4-HOUR VIRTUAL SEMINAR ON CHANGE CONTROL ACCORDING TO GXP AND GMP REQUIREMENTS

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      Handling Out-of-Trend Results in Pharmaceutical Quality Control as per Latest FDA Requirements

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      FDA Regulations for Environmental Monitoring (EM) Program

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      MDSAP Audits – All You Need to Know

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