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
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 | February 4-5, 2026
21 CFR Part 11 Compliance for SaaS/Cloud Applications
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location: Virtual Seminar | February 4-5, 2026
Understanding REACH and RoHS Compliance & Protecting Revenues with Advanced Compliance
Kelly Eisenhardt
Co-Founder and Managing Director at BlueCircle Advisors LLC
Location: Virtual Seminar | February 10, 2026
Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
Kevin J Slatkavitz, Ph.D
President & Founder, ThinkQuality, LLC
Location: Virtual Seminar | February 18-19, 2026
Biostatistics for the Non-Statistician
Elaine Eisenbeisz
Owner, Omega Statistics.
Location: Virtual Seminar | February 19-20, 2026
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
Barry A. Friedman
Ph.D, Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Location: Virtual Seminar | February 20, 2026
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 | February 26-27, 2026
Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
Kevin J Slatkavitz, Ph.D
President & Founder, ThinkQuality, LLC
Location: Virtual Seminar | March 03-04, 2026
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
SOP Writing, Training and Compliance in the Pharmaceutical Industry
Michael Esposito
Principal at TrainReach Consulting, LLC
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
Analytical Method Validation, Verification and Transfer
Kelly Thomas
Head Of Quality Assurance, Veru Inc
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Introduction to Design of Experiments: Methods and Analysis
Elaine Eisenbeisz
Owner, Omega Statistics
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
Quality Control Laboratory Compliance - cGMPs and GLPs
Kelly Thomas
Head Of Quality Assurance, Veru Inc
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
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
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
