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
Detecting Fraud and Misconduct in Clinical Trials
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How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach
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Payroll Best Practices: 10 Areas You Must Handle Correctly to Ensure Compliance
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The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products
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Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies - Application and Compliance to Ensure Safety of Biologic Therapeutics and Medical Devices
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Fraud and Risk (Self) Assessments Using Process Mapping and Documentation, Questionnaires and Root Cause Analysis
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Fraud and Risk (Self) Assessments Using Process Mapping and Documentation, Questionnaires and Root Cause Analysis
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Accounts Payable Systems: A guide to E-Payments, regulation, and financial transactions
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Regulatory Crisis Management: Best Practices for Dealing with the Common Crisis Events for the FDA-Regulated Industry
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Basic Principles of Cleaning Validation
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Trade Compliance Seminar - Harmonized Tariff Schedule/Schedule B and NAFTA Rules of Origin and Documentation
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Medical Device Software Risk Management, Cybersecurity and Assurance Case
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Operations Risk Management and Mitigation - from Assessment to Implementation
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Operations Risk Management and Mitigation - from Assessment to Implementation
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Meeting Regulatory Requirements (ICH, GMP, USP, FDA) for Analytical Procedures for Pharmaceutical Products: Validation, Verification and Transfer
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Meeting Regulatory Requirements (ICH, GMP, USP, FDA) for Analytical Procedures for Pharmaceutical Products: Validation, Verification and Transfer
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Implication of Global Medical Device Regulatory Requirements to Total Product Life Cycle: Practical Approach - from Concept to Market and Beyond
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Biotech/Biosimilar Products: Current and Emerging Analytical CMC Expectations
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FDA's Regulation of Medical Devices and Strategies for their Successful Import, Marketing and Sale in the United States
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FDA Regulation of Pharmaceuticals, OTC Drugs and Cosmetics & Strategies for the Successful Shipment and Sale of these Products in the U.S
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