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
Good Manufacturing Practices (GMP)
Michael Esposito
Principal at TrainReach Consulting, LLC
Location: Virtual Seminar | April 16-17, 2026
21 CFR Part 11 Compliance for SaaS/Cloud Applications
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location: Virtual Seminar | April 22-23, 2026
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 | April 22-23, 2026
Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters
Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Location: Virtual Seminar | April 28-29, 2026
Computer System Validation (CSV) Boot Camp
Carolyn Troiano
ERP Project Manager, City of Richmond
Location: Virtual Seminar | April 28-29, 2026
Change Control Best Practices - Avoiding Unintended Consequences of Changes
Michael Ferrante
President, Quality and Compliance Associates LLC
Location: Virtual Seminar | May 5-6, 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 | May 12-13, 2026
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
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
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
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
Statistical Elements of Implementing ICH Quality Guidelines
Elaine Eisenbeisz
Owner, Omega Statistics
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
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
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
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
