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
Negotiating the Labor Agreement
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Medical Device Single Audit Program (MDSAP) - How to implement MDSAP in an existing Quality Management System (QMS)?
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How to Implement a Quality Management System According ISO 13485?
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How to apply ISO 62304 standard in a medical software development project?
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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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Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
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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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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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Biosimilars Analytical Characterization and Comparability Studies
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Understanding and Implementing the Medical Device Directive
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The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
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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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Food Marketing Claims: Risks of Enforcement Actions and Class Action Lawsuits, Defense Strategies and Best Practices
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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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