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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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US Immigration Compliance Training & Defense Strategies in the TRUMP Era
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Managing Vendor Risk: The Cybersecurity Perspective
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FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements
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REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
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The Development and Implementation of a Robust Food Safety, Defense and Quality Assurance System
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Human Factors and Predicate Combination Products
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Modern HIPAA Compliance - Managing Privacy, Security, and Breach Notification in a World of New Technologies, New Threats, and New Rules
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An Interactive Workshop on Auditing and FDA Quality Management System (QMS) For Medical Devices Including In Vitro Diagnostic Medical Devices | Day 3
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ISO 13485, ISO 14971, Quality Document Management, and Risk Management for Medical Devices
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The Internal Audit Function
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Sample Size Justification & Statistical Analysis for Performance Qualification (PQ) Studies
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Systematic Operating Procedures (SOPs) – What’s Really Required
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Systematic Operating Procedures (SOPs) – What’s Really Required
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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and TGA
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The Unthinkable: Violence in Healthcare - From Bullying to an Active Shooter
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21 CFR (Código de Regulamentos Federais) Parte 11 conformidade para a validação de software e SaaS (Software como Serviço)/Cloud
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Microbial Contamination Control in Aseptic and Non-Sterile Manufacturing
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FDA's Quality System Regulation | Day 1
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The Regulations of OTC Drugs
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