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
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
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
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
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
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 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
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
FDA Recalls - Before You Start, and After You Finish
Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Clinical Data Management (CDM)
Elaine Eisenbeisz
Owner, Omega Statistics
Simu Live
On-demand Streaming - Virtual Training Through WebEx
