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
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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Computer System Validation- Reduce Costs and Avoid 483
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Computer System Validation- Reduce Costs and Avoid 483
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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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U.S. Human Food and Animal Feed Law- Issues Related to Food Safety, Formulation, Ingredients, Manufacturing, Labeling, Exporting and the Sale of Products in the United States
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Compliance Processes for Life Science Products in Brazil, Russia, India, China markets - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations
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HIPAA Omnibus Rule Compliance- Understanding Roles and Responsibilities of Privacy and Security Officers
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How to prepare a 510(k) Notification and a Technical File for the CE Mark
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Latin America - Understanding Regulatory Compliance Requirements Across The Life Science Industry
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Effective Complaint Handling, Medical Device Reporting and Recalls and Avoiding Costly Errors
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Understanding FDA QSR for Med Devices and Laser Product Performance Standards for Medical and Industrial Radiation Emitting Devices
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Medical Device Architecture - Design for Safety
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How To Build A World Class Environmental, Health & Safety Management System
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Design History Files, Device Master Records and Quality Management System for Medical Device Company - Principles of Lean Documents and Lean Configuration
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Regulatory, Technical and Partnership Management Challenges in the Co-development of Drugs and Diagnostics
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The OSHA Compliance 10 Hour Workshop
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