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
SOP Writing, Training and Compliance in the Pharmaceutical Industry
Michael Esposito
Principal at TrainReach Consulting, LLC
Location: Virtual Seminar | June 19-20, 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
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
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
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
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
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
Data Integrity: FDA/EU Requirements and Implementation
Mark Powell
Director, Mark Powell Scientific Limited
Simu Live
On-demand Streaming - Virtual Training Through WebEx
