Courses #Medical Device

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

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21 CFR PART 11 COMPLIANCE FOR ELECTRONIC RECORDS AND SIGNATURES

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

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Medical Device Hazard Analysis following ISO 14971

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Quality in Technology Transfer Projects

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RISK-BASED CLEANING VALIDATION

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Layered Process Audits for USFDA Regulated Industries

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ICH Q7 – GMPs for Active Pharmaceutical Ingredients

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OOS Test Results – Latest FDA Guidance

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Preventive Maintenance and Calibrations – Regulatory Expectations and Best Practices

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4-Hours Virtual Seminar – Medical Device Cybersecurity and FDA Compliance

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Steam Sterilization Microbiology and Autoclave Performance Qualification

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