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
Medical Device - QSR Compliant Product Development Process
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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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Fundamentals of Operational Risk Management - from Assessment to Implementation
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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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HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
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HIPAA Security and Breach Rule Compliance- Understanding Risk Analysis, Policies and Procedures and Managing Incidents
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Basic Clinical Research (On-time and under Budget)
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How to prevent your dietary supplement analytical laboratory from becoming a regulatory compliance risk
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Building a Sustainable Validation Program from Top to Bottom
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Best Practices for Managing Export Control & Customs Compliance
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FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies
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FDA's Regulation of OTC Drug Products
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GMP Compliance for Quality Control and Contract Laboratories
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GMP Compliance for Quality Control and Contract Laboratories
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Analytical Instrument Qualification and System Validation
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Transferring a Medical OEM Molding and Assembly Operation to a Manufacturer With Validated Systems and Processes
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Managing FDA Inspections from Readiness through Follow Up Responses
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Regulatory Affairs in the USA (FDA) for Drugs and Biologics
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