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
Biosimilars Analytical Characterization and Comparability Studies
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Understanding and Implementing the Medical Device Directive
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Design Control Essentials for Medical Devices
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Effective Technical Writing in the Life Sciences
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Fighting Corruption - the FCPA, Anti-Bribery Act, and OECD compliance
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Good Corporate Governance
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The Use of Drug Master Files & Quality Agreements: Understanding and Meeting your Regulatory and Processing Responsibilities
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Medical Device Recall Management
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In Depth EU Medical Device Regulation (MDR) 2017/745 Training
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Food Marketing Claims: Risks of Enforcement Actions and Class Action Lawsuits, Defense Strategies and Best Practices
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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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Risk Management and Post Market Surveillance for Medical Devices: Developing a Better Living Knowledge Base to Improve it
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A Comprehensive View of FDA Regulations for Medical Devices
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