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
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
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
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
The ACH Network – Electronic Payments in Detail, ACH 101, ACH 201, and ACH 301
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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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Effective Technical Writing in the Life Sciences
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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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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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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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Conducting Successful FDA Meetings to Negotiate Product Development and Approval
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Applying Risk Management to Your Organization
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How to survive your next investigator site inspection
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