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
Lead Auditor EN ISO 13485:2021 and EU MDR 2017/745 - Regulation
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How to Create Clinical Evaluation According to EU MDR 2017/745 Article 61 and Annex XIV?
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Statistics for Process Control
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Statistics for Quality Control
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How to Implement MDSAP-Requirements into Your ISO 13485 Quality Management System?
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Regression and Beyond! Elements of Predictive Modeling in R
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Statistical Elements of Post Market Clinical Follow-up (PMCF)
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Proven Practices to Help Manage Your Work-From-Home Employees
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Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency
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Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions
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Auditing and Compliance - International Trade Finance
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Integrating Design Controls and the Product Development Process for Effective and Compliant Medical Device Development
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Adaptive IT Audit System
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Clinical Trial Ethics - Right, wrong and the grey area in between
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Clinical Trial Management Systems - Tackling the steps for Clinical Software Validation
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Medical Device Imports - FDA's New Import Program Concerning International Consequences
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Improve Supplier Quality (for Clinical Trial Projects) - Learn How to Implement a Robust Request for Proposal Process
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Design Controls - A Roadmap to Successful Implementation
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Medical Device Recall - FDA Authority, Policy and Best Practices to Avoid / Manage
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Understanding and Implementing the Medical Device Directive
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