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 Analysis for Process and Product Development
Speaker

Steven Wachs
Principal Statistician, Integral Concepts, Inc

Location

Location: Virtual Seminar | June 7-8, 2023

* For one Registration $1699

21 CFR Part 11 Compliance for SaaS/Cloud Applications
Speaker

David Nettleton
FDA Compliance Specialist, Computer System Validation

Location

Location: Virtual Seminar | June 14-15, 2023

* For one Registration $1899

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 | June 14-15, 2023

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 22-23, 2023

* For one Registration $1899

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

Donna K Olheiser
Owner, Dynamic Mastership, LLC

Location

Location: Virtual Seminar | June 28-29, 2023

* For one Registration $1499

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

David Nettleton
Joy McElroy, Principle Consultant at Maynard Consulting Company

Location

Location: Virtual Seminar | July 13-14, 2023

* For one Registration $1899

IEC 60601-1 (3.1) The New Paradigm for Medical Device Safety
Speaker

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

Location

Location: Virtual Seminar | August 14-15, 2023

* For one Registration $1499

Statistical Elements of Implementing ICH Quality Guidelines
Speaker

Elaine Eisenbeisz
Owner, Omega Statistics

Location

Location: Virtual Seminar | Oct 26-27, 2023

* For one Registration $1499

Is your Medical Device Software 510(k) Ready?
Currently This Seminar is in the process of Getting Scheduled
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Employment Laws Certificate Program for HR Professionals, Managers and Supervisors
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Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
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Essentials Of USP Microbiology - Reading Between the Lines of the USP General and Information Microbiology Chapters
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* For one Registration $1699

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
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Verification and Validation - Product, Equipment/Process, Software and QMS
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* For one Registration $1499

Radiation Sterilization of Medical Products - Beyond the Basics
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* For one Registration $1699

6 Hr Virtual Seminar on FinTech for Non-IT Professionals
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Biocompatibility Testing for Medical Devices
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Transforming Corporate Spending Processes: T&E and AP Best Practices and Digitization
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Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
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* For one Registration $1299

21 CFR Part 11, Data Integrity, and Computer System Validation
Currently This Seminar is in the process of Getting Scheduled
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* For one Registration $999

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