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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Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries): 2-Day Virtual Seminar
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 $1199

Quality Control Laboratory Compliance - cGMPs and GLPs
Speaker

Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

Building a Vendor Qualification Program for FDA Regulated Industries
Speaker

Joy McElroy
Principle Consultant at Maynard Consulting Company

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

Compliance with Environmental, Social, and Governance (ESG) Requirements
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $599

Medical Devices - Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls
Speaker

Prof. Dr. h.c. Frank Stein
, Senior Medical Device Expert, Nemius Consulting GmbHSimu Live
On-demand Streaming - Virtual Training Through WebEx

Prof. Dr. h.c. Frank Stein, Senior Medical Device Expert, Nemius Consulting GmbHspan>

Location

Location: Virtual Seminar | September 9, 2024

* For one Registration $649

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 $1199

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 $1199

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 $1199

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 $999

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 $1199

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 $1199

Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
Speaker

Alexander Zachos
Director, US Regulatory Advertising and Promotion at Takeda Pharmaceuticals

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

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 $1199

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 $1199

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 $1199

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 $1199

Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents
Speaker

Rita Hoffman, RAC
Managing Partner Regs & Recall Strategies, LLC and Former FDA CDRH Recall Branch Chief

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $999

FDA Audit, Quality Assurance Practices, Responsibilities and Expectations
Speaker

Kenneth Christie
Chief Operating Officer, VTS Consultants Inc and ISPE Examination Development Committee (EDC) Member

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

Case Management Boot Camp: Strategies for Success in the Acute Care Setting and Beyond!
Speaker

Laura Ostrowsky
President, NYC chapter of CMSA

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $649

Method Development and Validation for Assays Supporting Testing of Biologics
Speaker

Gwen Wise-Blackman, Ph.D
Principal Consultant, Gwen Wise-Blackman Consulting, LLC

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1199

 

 

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