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
Building a Vendor Qualification Program for FDA Regulated Industries
Joy McElroy
Principle Consultant at Maynard Consulting Company
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
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
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
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
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering
Theodore Sand & Randall Thoma
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
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Barry A. Friedman
Ph.D, Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
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
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
Radiation Sterilization of Medical Products - Beyond the Basics
Martin Byrne
Sterilization Consultant, Sterilization Illustrated
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Sustainable Compliance for Out of Specifications (OOS) Results, Deviations, and Corrective and Preventive Actions (CAPA)
Rajesh K Gupta
Visionary Scientific and Compliance Consultant, Biologics Quality & Regulatory Consultants, LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact
Casper E. 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
FDA Audit, Quality Assurance Practices, Responsibilities and Expectations
Kenneth Christie
Chief Operating Officer, VTS Consultants Inc and ISPE Examination Development Committee (EDC) Member
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Case Management Boot Camp: Strategies for Success in the Acute Care Setting and Beyond!
Laura Ostrowsky
President, NYC chapter of CMSA
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Method Development and Validation for Assays Supporting Testing of Biologics
Gwen Wise-Blackman, Ph.D
Principal Consultant, Gwen Wise-Blackman Consulting, LLC
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
Robert J. Russell
President and CEO, RJR Consulting, Inc.
Simu Live
On-demand Streaming - Virtual Training Through WebEx
