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
FDA Inspection Essentials
Danielle DeLucy
Owner, ASA Training and Consulting, LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
2-Day Virtual Seminar on Operations Risk - Active Management and Compliance
Richard Barr & Stanley Epstein
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Barry A. Friedman
Ph.D, Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Business Continuity and Scenario Planning
Richard Barr
Operational Risk & Back Office Specialist
Simu Live
On-demand Streaming - Virtual Training Through WebEx
FDA’s Tougher Import Program in 2022
Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Medical Device Software Validation Training - IEC 62304
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Verification and Validation - Product, Equipment/Process, Software and QMS
John E Lincoln
Principal, J. E. Lincoln and Associates
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Risk Management in Medical Devices Industry
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Understanding FDA and Avoiding Inspections Leading to Warning Letters, Seizures, Injunctions and Prosecutions
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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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Overview of FDA Regulation of Medical Products: Drug, Device, Biologic or Combination
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Obtaining Faster FDA 510(k) Clearance - The 510(k) as an Advocacy Document
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Advanced Issues in the Harassment and Sex Discrimination World
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The HITECH-HIPAA Updates: New Changes to the Regulations, New Enforcement, and Audits
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