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

 

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FDA's Import Requirements and Managing the Import of FDA Regulated Products
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Applying the FDA Food Safety Modernization Act (FSMA) to Your Organization
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Detecting and Preventing Internal and External Fraud
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Protecting the Integrity of Your Financial Transactions: A fraud Risk Assessment and Prevention Toolkit
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Statistical Techniques for Medical Devices and Diagnostics
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Documenting an Effective Medical Device Quality Management System
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Medical Device Sterilization: Corrective & Preventive Action
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Medical Device Labeling (In-Vitro Lab "Home Brew" off - Label Guidance and Enforcement)
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Process Validation - Practical Solutions and Strategies for the Medical Device
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Creating and Implementing an Effective Risk Management System - Why FMEAs by Themselves are Not Risk Management Systems
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Procure-to-Pay Fraud: Detecting and Preventing Purchasing, Receiving and Disbursement Frauds
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Marketing Your Medical Device - From Conventional Ads to Referral Marketing and Social Media
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Why is FDA at my facility, and what do I do during an inspection?
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Introduction to Risk Management and Business Process Mapping Skills
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Process Validation for Medical Devices
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Auditing Human Resources and Assuring Compliance in Administration
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SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations

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How to Prepare for an FDA Meeting: Making the Most of Pre-IND/IDE, pre-NDA and Other Critical Meetings
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GMP Compliance for Quality Control and Contract Laboratories
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Managing an Effective AML Compliance Program
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