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
A Comprehensive View of FDA Regulations for Medical Devices
Stephanie Harrell
Consultant, ProPharma Group (Ex-FDA Investigator)
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Alexander Zachos
Director, US Regulatory Advertising and Promotion at Takeda Pharmaceuticals
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Project Management for Human Resources
Rebecca Staton Reinstein
President, Advantage Leadership Inc
Simu Live
On-demand Streaming - Virtual Training Through WebEx
21 CFR Part 11, Data Integrity, and Computer System Validation
Eric Henry
Senior Quality Systems and Compliance Advisor, King and Spalding LLP
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines
Mark Powell
Director, Mark Powell Scientific Limited
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions
Casper E. Uldriks
Former Associate Center Director of FDA's CDRH
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Charity Ogunsanya
CEO and Founder, Pharmabiodevice Consulting LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
California Leaves of Absence - Employer Obligations, Leave Interactions, and Handling Problems and Performance Management Challenges - PDL, FMLA, FEHA, SDI, CFRA, PFL, ADA, and Workers Compensation
Diane L. Dee
President, Advantage HR Consulting
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
Haja Sittana El Mubarak
Vice President, Regulatory Affairs, In Vitro Diagnostics
Simu Live
On-demand Streaming - Virtual Training Through WebEx
The Drug Development Process from Concept to Market
Mark Powell
Director, Mark Powell Scientific Limited
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Laboratory Inspection and Auditing
Mark Powell
Director, Mark Powell Scientific Limited
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Biocompatibility Testing: What You Need to Know
Mike Colvin Ph.D
Medical Device Technical Adviser/Consultant
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Mark Powell
Director, Mark Powell Scientific Limited
Simu Live
On-demand Streaming - Virtual Training Through WebEx
ACH Exception Processes Workshop
Donna K Olheiser
Owner, Dynamic Mastership, LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
FDA Inspection Essentials
Danielle DeLucy
Owner, ASA Training and Consulting, LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Global Regulations for Equipment Qualification and Validation of Processes in the Pharma Manufacturing
Joy McElroy
Principle Consultant at Maynard Consulting Company
Simu Live
On-demand Streaming - Virtual Training Through WebEx
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
Cynthia Brysch
Principal Consultant, Vertex Pharmaceuticals
Simu Live
On-demand Streaming - Virtual Training Through WebEx
FDA’s Tougher Import Program in 2022
Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents
Rita Hoffman, RAC
Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Designing and Sustaining New and Existing Product Stability Testing Program
Charity Ogunsanya
CEO and Founder, Pharmabiodevice Consulting LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
