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 Device Software Validation Training - IEC 62304
Prof. Dr. h.c. Frank Stein
Senior Medical Device Expert, Nemius Consulting GmbH
Location: Virtual Seminar | March 16, 2026
Verification and Validation - Product, Equipment/Process, Software and QMS : 2-Day Virtual Seminar
John E Lincoln
Principal, J. E. Lincoln and Associates
Location: Virtual Seminar | March 17-18, 2026
SOP Writing, Training and Compliance in the Pharmaceutical Industry
Michael Esposito
Principal at TrainReach Consulting, LLC
Location: Virtual Seminar | March 19-20, 2026
Change Control Best Practices - Avoiding Unintended Consequences of Changes
Michael Ferrante
President, Quality and Compliance Associates LLC
Location: Virtual Seminar | March 23-24, 2026
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
Location: Virtual Seminar | March 26-27, 2026
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
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
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
Enterprise Risk Management (ERM)
Richard Barr
Operational Risk & Back Office Specialist
Simu Live
On-demand Streaming - Virtual Training Through WebEx
