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
Quality Control Laboratory Compliance - cGMPs and GLPs
Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer
Location: Virtual Seminar | October 12-13, 2023
Understanding REACH and RoHS Compliance & Protecting Revenues with Advanced Compliance
Kelly Eisenhardt
Co-Founder and Managing Director at BlueCircle Advisors LLC
Location: Virtual Seminar | October 18-19, 2023
21 CFR Part 11 Compliance for SaaS/Cloud Applications
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location: Virtual Seminar | October 25-26, 2023
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 | October 25-26, 2023
Statistical Elements of Implementing ICH Quality Guidelines
Elaine Eisenbeisz
Owner, Omega Statistics
Location: Virtual Seminar | Oct 26-27, 2023
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 | November 9, 2023
Compliance with Environmental, Social, and Governance (ESG) Requirements
Richard Barr
Operational Risk & Back Office Specialist
Location: Virtual Seminar | January 15, 2024
Risk Based Internal Auditing (RBIA)
Richard Barr
Operational Risk & Back Office Specialist
Location: Virtual Seminar | January 17-18, 2024
Complete 1099, TIN Matching, B-Notice, FATCA and Nonresident Alien 1042-S Compliance Update
Miles Hutchinson
CGMA, President of Sales Tax Advisors, Inc.
Location: Virtual Seminar | January 17-18, 2024
Fundamentals of the Management and Mitigation of Operational Risk in banks
Richard Barr
Operational Risk & Back Office Specialist
Location: Virtual Seminar | February 5-6, 2024
Analytical Instrument Qualification and Computer System Validation
Mark Powell
Director, Mark Powell Scientific Limited
Location: San Francisco, CA | February 5-6, 2024
2-Day In-Person Seminar
Enterprise Risk Management (ERM)
Richard Barr
Operational Risk & Back Office Specialist
Location: Virtual Seminar | March 4-5, 2024
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Change Control Best Practices - Avoiding Unintended Consequences of Changes
Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Building a Vendor Qualification Program for FDA Regulated Industries
Joy McElroy
Principle Consultant at Maynard Consulting Company
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Alexander Zachos
Director, US Regulatory Advertising and Promotion at Takeda Pharmaceuticals
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents
Rita Hoffman, RAC
Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief
Simu Live
On-demand Streaming - Virtual Training Through WebEx
2-Day Virtual Seminar on Operations Risk - Active Management and Compliance
Richard Barr & Stanley Epstein
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Business Continuity and Scenario Planning
Richard Barr
Operational Risk & Back Office Specialist
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
