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
Statistical Elements of Implementing ICH Quality Guidelines
Elaine Eisenbeisz
Owner, Omega Statistics
Location: Virtual Seminar | Dec 7-8, 2023
Compliance with Environmental, Social, and Governance (ESG) Requirements
Richard Barr
Operational Risk & Back Office Specialist
Location: Virtual Seminar | January 15, 2024
Complete 1099, TIN Matching, B-Notice, FATCA and Nonresident Alien 1042-S Compliance Update
Miles Hutchinson
CGMA, President of Sales Tax Advisors, Inc.
Location: Virtual Seminar | January 17-18, 2024
Risk Based Internal Auditing (RBIA)
Richard Barr
Operational Risk & Back Office Specialist
Location: Virtual Seminar | January 17-18, 2024
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location: Virtual Seminar | January 24-25, 2024
21 CFR Part 11 Compliance for SaaS/Cloud Applications
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location: Virtual Seminar | January 24-25, 2024
Analytical Instrument Qualification and Computer System Validation
Mark Powell
Director, Mark Powell Scientific Limited
Location: San Francisco, CA | February 5-6, 2024
2-Day In-Person Seminar
Fundamentals of the Management and Mitigation of Operational Risk in banks
Richard Barr
Operational Risk & Back Office Specialist
Location: Virtual Seminar | February 5-6, 2024
Data Integrity: FDA/EU Requirements and Implementation
Mark Powell
Director, Mark Powell Scientific Limited
Location: San Francisco, CA | February 8-9, 2024
2-Day In-Person Seminar
Quality Control Laboratory Compliance - cGMPs and GLPs
Kelly Thomas
Vice President, Americas Quality Operations at Stallergenes Greer
Location: Atlanta, GA | February 15-16, 2024
2-Day In-Person Seminar
Guidelines for Performing a Corporate Wide Internal Audit Risk Assessment and Fraud Risk Assessment
Marna Steuart
CIDA, CFE, CPA, Controller
Location: Virtual Seminar | February 21-22, 2024
Quality and GMP Compliance for Virtual Companies (Pharmaceutical, Medical Device & Biologics Industries)
David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
Location: San Francisco, CA | February 22-23, 2024
2-Day In-Person Seminar
Enterprise Risk Management (ERM)
Richard Barr
Operational Risk & Back Office Specialist
Location: Virtual Seminar | March 4-5, 2024
Statistical Analysis for Process and Product Development
Steven Wachs
Principal Statistician, Integral Concepts, Inc
Location: Virtual Seminar | March 13-14, 2024
Understanding REACH and RoHS Compliance & Protecting Revenues with Advanced Compliance
Kelly Eisenhardt
Co-Founder and Managing Director at BlueCircle Advisors LLC
Location: Virtual Seminar | March 18-19, 2024
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Change Control Best Practices - Avoiding Unintended Consequences of Changes
Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance
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
Medical Devices - Post Market Surveillance: Product Complaints Management, Medical Device Reporting, Vigilance Reporting, Product Recalls
Prof. Dr. h.c. Frank Stein
, Senior Medical Device Expert, Nemius Consulting GmbH
Simu Live
On-demand Streaming - Virtual Training Through WebEx
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
Barry A. Friedman, Ph.D
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Simu Live
On-demand Streaming - Virtual Training Through WebEx
