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
How to apply ISO 62304 standard in a medical software development project?
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Applying ISO14971 / IEC62304 / IEC62366-1 - A Practical Guide On How To Implement Risk Management
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Human Error Reduction Program: How to investigate, predict, prevent, correct & recover from Human Error in the manufacturing floor and GMP environments
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Statistical Process and Quality Control
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HRM and the High Performance Organization
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Packaging and Labeling in Pharmaceutical Production
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Clinical Data Management (FDA E6 GCP Guidelines)
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Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11
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Aseptic Processing Overview and Validation
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Business Continuity & Scenario Planning
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Medical Device Seminar Series: QSR, Design Control and Pre-Market Submissions
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Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
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Managing Regulatory Inspections Training - The Dos and Don'ts Before, During And After an FDA GCP Inspection
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Risk Management Challenges and Solutions: A Practical, Cost-Effective, Hands-On Approach to Implementing Risk and Internal Controls from a Management Perspective
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Navigating Federal Wage and Hour Compliance Issues under the Fair Labor Standards Act
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Clinical Trial Essentials; Implementation Best Practice
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Facility, Maintenance and Calibration Considerations of the Quality Systems Inspection Technique (QSIT)
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Fundamentals of EU MDR and IVDR – Level 1
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Introduction into the EU IVDR 2017/746 - the new EU regulation for invitro diagnostic medical devices
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Financial Life Cycle of Clinical Research Studies: Best Practice Approaches
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