SEMINARS
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
Efficient Process Validation Strategies and Validation Master Plan (VMPs) for Medical Devices
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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 Design Control for Medical Devices Including In Vitro Diagnostic Devices | Day 1
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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 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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An Interactive Workshop on Premarket [510(k)] Notification Submissions
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