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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Statistical Elements of Implementing ICH Quality Guidelines
Speaker

Elaine Eisenbeisz
Owner, Omega Statistics

Location

Location: Virtual Seminar | Dec 7-8, 2023

* For one Registration $1699

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

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | January 15, 2024

* For one Registration $899

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

Location: Virtual Seminar | January 17-18, 2024

* For one Registration $1499

Risk Based Internal Auditing (RBIA)
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | January 17-18, 2024

* For one Registration $1499

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 | January 24-25, 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 | January 24-25, 2024

* For one Registration $1499

Analytical Instrument Qualification and Computer System Validation
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Location: San Francisco, CA | February 5-6, 2024
2-Day In-Person Seminar

* For one Registration $1899

certificate lunch Seminar Material tea/coffee
Fundamentals of the Management and Mitigation of Operational Risk in banks
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | February 5-6, 2024

* For one Registration $1499

Data Integrity: FDA/EU Requirements and Implementation
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Location: San Francisco, CA | February 8-9, 2024
2-Day In-Person Seminar

* For one Registration $1899

certificate lunch Seminar Material tea/coffee
Quality Control Laboratory Compliance - cGMPs and GLPs
Speaker

Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer

Location

Location: Atlanta, GA | February 15-16, 2024
2-Day In-Person Seminar

* For one Registration $1899

certificate lunch Seminar Material tea/coffee
Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment and Fraud Risk Assessment
Speaker

Marna Steuart
CIDA, CFE, CPA, Controller

Location

Location: Virtual Seminar | February 21-22, 2024

* For one Registration $1499

Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
Speaker

David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)

Location

Location: San Francisco, CA | February 22-23, 2024
2-Day In-Person Seminar

* For one Registration $1899

certificate lunch Seminar Material tea/coffee
Enterprise Risk Management (ERM)
Speaker

Richard Barr
Operational Risk & Back Office Specialist

Location

Location: Virtual Seminar | March 4-5, 2024

* For one Registration $1499

Statistical Analysis for Process and Product Development
Speaker

Steven Wachs
Principal Statistician, Integral Concepts, Inc

Location

Location: Virtual Seminar | March 13-14, 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 | March 18-19, 2024

* For one Registration $1499

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

Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

Change Control Best Practices - Avoiding Unintended Consequences of Changes
Speaker

Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance

Location

Simu Live
On-demand Streaming - Virtual Training Through WebEx

* For one Registration $1499

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

Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
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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