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

 

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The Veterinary Drug Approval Process and FDA Regulatory Oversight
Speaker

Mark Hughes
Consultant, Hughes Veterinary Consulting

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Speaker

Barry A. Friedman
Ph.D, Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $799

Radiation Sterilization of Medical Products - Beyond the Basics
Speaker

Martin Byrne
Sterilization Consultant, Sterilization Illustrated

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

FDA’s Tougher Import Program in 2022
Speaker

Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Medical Device Software Validation Training - IEC 62304
Speaker

Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $699

Verification and Validation - Product, Equipment/Process, Software and QMS
Speaker

John E Lincoln
Principal, J. E. Lincoln and Associates

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1699

Risk Management in Medical Devices Industry
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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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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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