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
Designing and Sustaining New and Existing Product Stability Testing Program
Charity Ogunsanya
CEO and Founder, Pharmabiodevice Consulting LLC
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
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
Statistical Elements of Implementing ICH Quality Guidelines
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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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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Introduction to Design of Experiments: Methods and Analysis
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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
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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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Statistical Analysis for Process and Product Development
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Effective Technical Writing in the Life Sciences
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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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FDA's Import Requirements and Managing the Import of FDA Regulated Products
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Applying the FDA Food Safety Modernization Act (FSMA) to Your Organization
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