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
Analytical Instrument Qualification and Computer System Validation
Mark Powell
Director, Mark Powell Scientific Limited
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries): 2-Day Virtual Seminar
David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Quality Control Laboratory Compliance - cGMPs and GLPs
Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer
Simu Live
On-demand Streaming - Virtual Training Through WebEx
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
Compliance with Environmental, Social, and Governance (ESG) Requirements
Richard Barr
Operational Risk & Back Office Specialist
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
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
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
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
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
