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
Medical Devices - Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH
Location: Virtual Seminar | June 10, 2025
SOP Writing, Training and Compliance in the Pharmaceutical Industry
Michael Esposito
Principal at TrainReach Consulting, LLC
Location: Virtual Seminar | June 19-20, 2025
Developing a Strategic Approach to FDA Compliance for Validation of Computer Systems
Carolyn Troiano
ERP Project Manager, City of Richmond
Location: Virtual Seminar | June 20, 2025
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location: Virtual Seminar | June 25-26, 2025
21 CFR Part 11 Compliance for SaaS/Cloud Applications
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location: Virtual Seminar | June 25-26, 2025
From Data to Decisions: Utilizing Regression Models
Elaine Eisenbeisz
Owner, Omega Statistics
Location: Virtual Seminar | July 18, 2025
Clinical Data Management (CDM)
Elaine Eisenbeisz
Owner, Omega Statistics
Location: Virtual Seminar | September 25-26, 2025
Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Verification and Validation - Product, Equipment/Process, Software and QMS : 2-Day Virtual Seminar
John E Lincoln
Principal, J. E. Lincoln and Associates
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Change Control Best Practices - Avoiding Unintended Consequences of Changes
Michael Ferrante
President, Quality and Compliance Associates LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Michael Ferrante
President, Quality and Compliance Associates LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Understanding REACH and RoHS Compliance & Protecting Revenues with Advanced Compliance
Kelly Eisenhardt
Co-Founder and Managing Director at BlueCircle Advisors LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Analytical Method Validation, Verification and Transfer
Kelly Thomas
Head Of Quality Assurance, Veru Inc
Simu Live
On-demand Streaming - Virtual Training Through WebEx
How to Conduct an ACH Risk Assessment and Develop an Effective ACH Risk Management Program
Donna K Olheiser
Owner, Dynamic Mastership, LLC
Location: Virtual Seminar | May 20-21, 2025
Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Medical Device Software Validation Training - IEC 62304
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
Robert J. Russell
President and CEO, RJR Consulting, Inc.
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment and Fraud Risk Assessment
Marna Steuart
CIDA, CFE, CPA, Controller
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Enterprise Risk Management (ERM)
Richard Barr
Operational Risk & Back Office Specialist
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Complete 1099, TIN Matching, B-Notice, FATCA and Nonresident Alien 1042-S Compliance Update
Miles Hutchinson
CGMA, President of Sales Tax Advisors, Inc.
Simu Live
On-demand Streaming - Virtual Training Through WebEx
