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
Understanding REACH and RoHS Compliance & Protecting Revenues with Advanced Compliance
Kelly Eisenhardt
Co-Founder and Managing Director at BlueCircle Advisors LLC
Location: Virtual Seminar | September 18-19, 2024
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)
Location: Virtual Seminar | Sept 26-27, 2024
Introduction to Design of Experiments: Methods and Analysis
Elaine Eisenbeisz
Owner, Omega Statistics
Location: Virtual Seminar | September 26-27, 2024
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
21 CFR Part 11 Compliance for SaaS/Cloud Applications
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location: Virtual Seminar | October 16-17, 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
Biostatistics for the Non-Statistician
Elaine Eisenbeisz
Owner, Omega Statistics.
Location: Virtual Seminar | October 17-18, 2024
Audits - Self/Internal, Vendor and Regulatory Inspections
John E Lincoln
Principal, J. E. Lincoln and Associates
Location: Virtual Seminar | November 12, 2024
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
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
