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
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Mark Powell
Director, Mark Powell Scientific Limited
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing
Joy McElroy
Principle Consultant at Maynard Consulting Company
Simu Live
On-demand Streaming - Virtual Training Through WebEx
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
Cynthia Brysch
Principal Consultant, Vertex Pharmaceuticals
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
Statistical Elements of Implementing ICH Quality Guidelines
Elaine Eisenbeisz
Owner, Omega Statistics
Simu Live
On-demand Streaming - Virtual Training Through WebEx
2023 Toxic Substance Control act (TSCA) Basics
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Effective Technical Writing in the Life Sciences
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Statistical Analysis for Process and Product Development
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Fundamentals of the Management and Mitigation of Operational Risk in banks
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ACH Exception Processes
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Risk Management in Medical Devices Industry
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Risk Based Internal Auditing (RBIA)
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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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