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 | October 4, 2024
The ACH Network – Electronic Payments in Detail, ACH 101, ACH 201, and ACH 301
Donna K Olheiser
Owner, Dynamic Mastership, LLC
Location: Virtual Seminar | October 9-10, 2024
Verification and Validation - Planning and Execution
John E Lincoln
Principal, J. E. Lincoln and Associates
Location: Virtual Seminar | October 15-16, 2024
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 16-17, 2024
21 CFR Part 11 Compliance for SaaS/Cloud Applications
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location: Virtual Seminar | October 16-17, 2024
Biostatistics for the Non-Statistician
Elaine Eisenbeisz
Owner, Omega Statistics.
Location: Virtual Seminar | October 17-18, 2024
Introduction to Design of Experiments: Methods and Analysis
Elaine Eisenbeisz
Owner, Omega Statistics
Location: Virtual Seminar | October 24-25, 2024
Audits - Self/Internal, Vendor and Regulatory Inspections
John E Lincoln
Principal, J. E. Lincoln and Associates
Location: Virtual Seminar | November 12, 2024
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 19-20, 2025
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
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
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
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
How to Conduct an ACH Risk Assessment and Develop an Effective ACH Risk Management Program
Donna K Olheiser
Owner, Dynamic Mastership, LLC
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
Technical Writing for Pharma, Biotech and Medical Devices
Mark Powell
Director, Mark Powell Scientific Limited
Simu Live
On-demand Streaming - Virtual Training Through WebEx
The Veterinary Drug Approval Process and FDA Regulatory Oversight
Mark Hughes
Consultant, Hughes Veterinary Consulting
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
Analytical Instrument Qualification and Computer System Validation
Mark Powell
Director, Mark Powell Scientific Limited
Simu Live
On-demand Streaming - Virtual Training Through WebEx
