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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Risk Based Internal Auditing (RBIA)
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | August 05-06, 2024

* For one Registration $1499

Compliance with Environmental, Social, and Governance (ESG) Requirements
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | August 08, 2024

* For one Registration $899

ACH Exception Processes
Speaker

Donna K Olheiser
Owner, Dynamic Mastership, LLC

Location

Location: Virtual Seminar | August 14, 2024

* For one Registration $899

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 | August 21-22, 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 | August 21-22, 2024

* For one Registration $1599

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

Michael Ferrante
President, Quality and Compliance Associates LLC

Location

Location: Virtual Seminar | August 27-28, 2024

* For one Registration $1499

Medical Devices - Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls
Speaker

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

Location

Location: Virtual Seminar | September 9, 2024

* For one Registration $899

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 | September 18-19, 2024

* For one Registration $1499

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

Location: Virtual Seminar | Sept 26-27, 2024

* For one Registration $1499

Introduction to Design of Experiments: Methods and Analysis
Speaker

Elaine Eisenbeisz
Owner, Omega Statistics

Location

Location: Virtual Seminar | September 26-27, 2024

* For one Registration $1499

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 $1499

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 $1299

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 $1299

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 $1499

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 $1499

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 $1299

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 $1299

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 $1299

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 $1499

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