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
A Comprehensive View of FDA Regulations for Medical Devices
Stephanie Harrell
Consultant, ProPharma Group (Ex-FDA Investigator)
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
Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters
Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
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
Statistical Elements of Implementing ICH Quality Guidelines
Elaine Eisenbeisz
Owner, Omega Statistics
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Effective Technical Writing in the Life Sciences
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Statistical Analysis for Process and Product Development
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Medical Device Software Validation Training - IEC 62304
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Fundamentals of the Management and Mitigation of Operational Risk in banks
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Risk Management in Medical Devices Industry
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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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