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 Recalls - Before You Start, and After You Finish
Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH
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
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering
Theodore Sand & Randall Thoma
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents
Rita Hoffman, RAC
Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Clinical Data Management (CDM)
Elaine Eisenbeisz
Owner, Omega Statistics
Simu Live
On-demand Streaming - Virtual Training Through WebEx
In Depth EU Medical Device Regulation (MDR) 2017/745 Training
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Developing a Strategic Approach to FDA Compliance for Validation of Computer Systems
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Computer System Validation (CSV) Boot Camp
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The ACH Network – Electronic Payments in Detail, ACH 101, ACH 201, and ACH 301
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Audits - Self/Internal, Vendor and Regulatory Inspections
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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
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Statistical Analysis for Process and Product Development
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Effective Technical Writing in the Life Sciences
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2023 Toxic Substance Control act (TSCA) Basics
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Fundamentals of the Management and Mitigation of Operational Risk in banks
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From Data to Decisions: Utilizing Regression Models
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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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Conducting Effective Investigation of Out-of-Specs and Atypical Laboratory Data
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