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

 

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Medical Device Software Validation Training - IEC 62304
Speaker

Prof. Dr. h.c. Frank Stein
, Senior Medical Device Expert, Nemius Consulting GmbH

Location

Location: Virtual Seminar | October 4, 2024

* For one Registration $899

The ACH Network – Electronic Payments in Detail, ACH 101, ACH 201, and ACH 301
Speaker

Donna K Olheiser
Owner, Dynamic Mastership, LLC

Location

Location: Virtual Seminar | October 9-10, 2024

* For one Registration $1299

Verification and Validation - Planning and Execution
Speaker

John E Lincoln
Principal, J. E. Lincoln and Associates

Location

Location: Virtual Seminar | October 15-16, 2024

* For one Registration $1499

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
Speaker

David Nettleton
FDA Compliance Specialist, Computer System Validation

Location

Location: Virtual Seminar | October 16-17, 2024

* For one Registration $1599

21 CFR Part 11 Compliance for SaaS/Cloud Applications
Speaker

David Nettleton
FDA Compliance Specialist, Computer System Validation

Location

Location: Virtual Seminar | October 16-17, 2024

* For one Registration $1599

Biostatistics for the Non-Statistician
Speaker

Elaine Eisenbeisz
Owner, Omega Statistics.

Location

Location: Virtual Seminar | October 17-18, 2024

* For one Registration $1499

Introduction to Design of Experiments: Methods and Analysis
Speaker

Elaine Eisenbeisz
Owner, Omega Statistics

Location

Location: Virtual Seminar | October 24-25, 2024

* For one Registration $1499

Audits - Self/Internal, Vendor and Regulatory Inspections
Speaker

John E Lincoln
Principal, J. E. Lincoln and Associates

Location

Location: Virtual Seminar | November 12, 2024

* For one Registration $799

Understanding REACH and RoHS Compliance & Protecting Revenues with Advanced Compliance
Speaker

Kelly Eisenhardt
Co-Founder and Managing Director at BlueCircle Advisors LLC

Location

Location: Virtual Seminar | February 19-20, 2025

* For one Registration $1299

Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Speaker

Michael Ferrante
President, Quality and Compliance Associates LLC

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
Speaker

David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

Complete 1099, TIN Matching, B-Notice, FATCA and Nonresident Alien 1042-S Compliance Update
Speaker

Miles Hutchinson
CGMA, President of Sales Tax Advisors, Inc.

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1099

Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment and Fraud Risk Assessment
Speaker

Marna Steuart
CIDA, CFE, CPA, Controller

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1099

Change Control Best Practices - Avoiding Unintended Consequences of Changes
Speaker

Michael Ferrante
President, Quality and Compliance Associates LLC

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

How to Conduct an ACH Risk Assessment and Develop an Effective ACH Risk Management Program
Speaker

Donna K Olheiser
Owner, Dynamic Mastership, LLC

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1099

Enterprise Risk Management (ERM)
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

Technical Writing for Pharma, Biotech and Medical Devices
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

The Veterinary Drug Approval Process and FDA Regulatory Oversight
Speaker

Mark Hughes
Consultant, Hughes Veterinary Consulting

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

Data Integrity: FDA/EU Requirements and Implementation
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

Analytical Instrument Qualification and Computer System Validation
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

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