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Upcoming In-person and Virtual Seminars by Ex-FDA and other regulatory experts.
Get Trained on - FDA Audits and Inspections, FDA’s GMP Expectations, Clinical Trials, Vendor Selection, FDA’s New Import Program, FDA Recalls, CAPA and more

 

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How to prepare a 510(k) Notification and a Technical File for the CE Mark
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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
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FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
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How to Perform a Cognitive Load Assessment for Human Error Reduction
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The A to Z of Trade Compliance for a U.S. Entity
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Building an AML/CTF Assurance Program
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GMP Compliance for Quality Control and Contract Laboratories
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World Class Risk Management - What The Best International Standards Say About Risk - ISO 31000, ISO 14971 and ICH Q9
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Payroll Best Practices: 10 Areas You Must Handle Correctly to Ensure Compliance
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Technical and Regulatory Writing for FDA Regulated Industries
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MetricStream Roundtable: Meet CEO of MetricStream (#2 Most Influential African American in Technology)
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Supplier Quality Agreements - Essential for suppliers of most outsourced processes
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HUMAN RESOURCES BOOT CAMP: Focus on developments in employment law including sexual harassment
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Compliance in Medical Device Reprocessing - Improving Patient Safety and Department Performance
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FDA Penalties for Non-Compliance in Pharma - 2017 case studies and Readiness for 2018
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Drug Dissolution Testing and Establishing Plasma Drug Levels in Humans
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Biostatistics for the Non-Statistician
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Developing Documents and Records to meet ISO 17025 Requirements
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Principles and Application of Hazard Analysis Critical Control Point (HACCP)
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Incident Management and Crisis Prevention for Food and Consumer Goods Companies
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