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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Regulatory Compliance for Dietary Supplements in the US, EU and Canada
Speaker

Travis Austin MacKay
Director of Regulatory Affairs, Plexus Worldwide

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1699

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters
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

A Comprehensive View of FDA Regulations for Medical Devices
Speaker

Stephanie Harrell
Consultant, ProPharma Group (Ex-FDA Investigator)

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing
Speaker

Joy McElroy
Principle Consultant at Maynard Consulting Company

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
Speaker

Cynthia Brysch
Principal Consultant, Vertex Pharmaceuticals

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)
Speaker

Robert J. Russell
President and CEO, RJR Consulting, Inc.

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

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 $1499

Designing and Sustaining New and Existing Product Stability Testing Program
Speaker

Charity Ogunsanya
CEO and Founder, Pharmabiodevice Consulting LLC

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

FDA Recalls - Before You Start, and After You Finish
Speaker

Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering
Speaker

Theodore Sand & Randall Thoma

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

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 $1299

Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
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 $1699

Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions
Speaker

Casper E. Uldriks
Former Associate Center Director of FDA's CDRH

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
Speaker

Haja Sittana El Mubarak
Vice President, Regulatory Affairs, In Vitro Diagnostics

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1699

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

Sustainable Compliance for Out of Specifications (OOS) Results, Deviations, and Corrective and Preventive Actions (CAPA)
Speaker

Rajesh K Gupta
Visionary Scientific and Compliance Consultant, Biologics Quality & Regulatory Consultants, LLC

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact
Speaker

Casper E. Uldriks
Former Associate Center Director of FDA's CDRH

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Radiation Sterilization of Medical Products - Beyond the Basics
Speaker

Martin Byrne
Sterilization Consultant, Sterilization Illustrated

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

 

 

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