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 and Preventing Health Care Fraud and Ethics for Fraud Deterrence
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Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC)
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Changes to the 510(k) System - Impact on Innovation, Investment, and Business Development
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Managing Employee Leaves, Health Issues, Disability and Job Accommodation: A Practical Guide to the ADA, FMLA, Workers' Compensation, and Military Leave
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The European Clinical Trial Directive…Plus…European Filings and Registration Procedures
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Clear as Mud: Obtaining & Marketing your 510(K) with Today's FDA
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Effective Risk Management Strategies for the Department and the Enterprise
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Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices
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Acceptance Sampling - The Total Picture
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Best Practices for Managing Export Control & Customs Compliance
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The Importance of a Risk Based Approach in Implementing and Maintaining an Enterprise Wide Compliance Program
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Fraud Examiners: Get Deeply Into the White Collar Criminal Mind to Develop Outstanding Interviewing Skills
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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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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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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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