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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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Speaker

Michael Ferrante
President, Quality and Compliance Associates LLC

Location

Location: Virtual Seminar | June 03-04, 2024

* For one Registration $1499

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

Location: Virtual Seminar | June 6-7, 2024

* For one Registration $1499

Quality Control Laboratory Compliance - cGMPs and GLPs
Speaker

Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer

Location

Location: Virtual Seminar | June 20-21, 2024

* For one Registration $1499

Understanding REACH and RoHS Compliance & Protecting Revenues with Advanced Compliance
Speaker

Kelly Eisenhardt
Co-Founder and Managing Director at BlueCircle Advisors LLC

Location

Location: Virtual Seminar | June 27-28, 2024

* For one Registration $1499

Risk Based Internal Auditing (RBIA)
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | August 05-06, 2024

* For one Registration $1499

21 CFR Part 11 Compliance for SaaS/Cloud Applications
Speaker

David Nettleton
FDA Compliance Specialist, Computer System Validation

Location

Location: Virtual Seminar | August 21-22, 2024

* For one Registration $1599

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
Speaker

David Nettleton
FDA Compliance Specialist, Computer System Validation

Location

Location: Virtual Seminar | August 21-22, 2024

* For one Registration $1599

Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment and Fraud Risk Assessment
Speaker

Marna Steuart
CIDA, CFE, CPA, Controller

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Complete 1099, TIN Matching, B-Notice, FATCA and Nonresident Alien 1042-S Compliance Update
Speaker

Miles Hutchinson
CGMA, President of Sales Tax Advisors, Inc.

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Change Control Best Practices - Avoiding Unintended Consequences of Changes
Speaker

Michael Ferrante
President, Quality and Compliance Associates LLC

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

Enterprise Risk Management (ERM)
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

How to Conduct an ACH Risk Assessment and Develop an Effective ACH Risk Management Program
Speaker

Donna K Olheiser
Owner, Dynamic Mastership, LLC

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Analytical Instrument Qualification and Computer System Validation
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

Technical Writing for Pharma, Biotech and Medical Devices
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

Data Integrity: FDA/EU Requirements and Implementation
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

The Veterinary Drug Approval Process and FDA Regulatory Oversight
Speaker

Mark Hughes
Consultant, Hughes Veterinary Consulting

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1299

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 $799

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 $1499

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 GmbH

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $699

Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters
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 $1499

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