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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Quality Control Laboratory Compliance - cGMPs and GLPs
Speaker

Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer

Location

Location: Virtual Seminar | October 12-13, 2023

* For one Registration $1299

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 | October 18-19, 2023

* For one Registration $1899

21 CFR Part 11 Compliance for SaaS/Cloud Applications
Speaker

David Nettleton
FDA Compliance Specialist, Computer System Validation

Location

Location: Virtual Seminar | October 25-26, 2023

* 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 25-26, 2023

* For one Registration $1499

Statistical Elements of Implementing ICH Quality Guidelines
Speaker

Elaine Eisenbeisz
Owner, Omega Statistics

Location

Location: Virtual Seminar | Oct 26-27, 2023

* 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 | November 9, 2023

* For one Registration $899

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

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | January 15, 2024

* For one Registration $899

Risk Based Internal Auditing (RBIA)
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | January 17-18, 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

Location: Virtual Seminar | January 17-18, 2024

* For one Registration $1499

Fundamentals of the Management and Mitigation of Operational Risk in banks
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | February 5-6, 2024

* For one Registration $1499

Analytical Instrument Qualification and Computer System Validation
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Location: San Francisco, CA | February 5-6, 2024
2-Day In-Person Seminar

* For one Registration $1899

Enterprise Risk Management (ERM)
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | March 4-5, 2024

* For one Registration $1499

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

Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

Change Control Best Practices - Avoiding Unintended Consequences of Changes
Speaker

Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

Building a Vendor Qualification Program for FDA Regulated Industries
Speaker

Joy McElroy
Principle Consultant at Maynard Consulting Company

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Speaker

Alexander Zachos
Director, US Regulatory Advertising and Promotion at Takeda Pharmaceuticals

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents
Speaker

Rita Hoffman, RAC
Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

2-Day Virtual Seminar on Operations Risk - Active Management and Compliance
Speaker

Richard Barr & Stanley Epstein

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Business Continuity and Scenario Planning
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
Speaker

Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

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