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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The Drug Development Process from Concept to Market
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Location : Virtual Seminar | July 27, 2021

* For one Registration $1099

21 CFR Part 11 Compliance for SaaS/Cloud Applications
Speaker

David Nettleton
FDA Compliance Specialist, Computer System Validation

Location

Location : Virtual Seminar | August 4-5, 2021

* 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 | August 4-5, 2021

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
Speaker

Robert J. Russell
President and CEO, RJR Consulting, Inc

Location

Location : Virtual Seminar | August 11, 2021

* For one Registration $999

Internal Audit, Fraud Risk Assessment and Risk Management Annual Plan
Speaker

Marna Steuart
CIDA, CFE, CPA, Controller

Location

Location : Virtual Seminar | August 12-13, 2021

* For one Registration $1299

REACH and RoHS Compliance: Gain a Deeper Understanding
Speaker

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

Location

Location : Virtual Seminar | August 12-13, 2021

* For one Registration $1499

Radiation Sterilization of Medical Products - Beyond the Basics
Speaker

Martin Byrne,
Sterilization Consultant, Sterilization Illustrated

Location

Location : Virtual Seminar | August 12-13, 2021

* For one Registration $1899

Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions
Speaker

Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH

Location

Location : Virtual Seminar | August 12-13, 2021

* For one Registration $1299

Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices
Speaker

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

Location

Location : Virtual Seminar | August 19-20, 2021

* For one Registration $1299

Managing an Effective AML Compliance Program
Speaker

Justin Muscolino
Head of North America Compliance Training, GRC Solutions Pty Ltd

Location

Location : Virtual Seminar | August 23-24, 2021

* For one Registration $1299

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

Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance

Location

Location : Virtual Seminar | August 25-26, 2021

* For one Registration $1299

Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
Speaker

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

Location

Location : Virtual Seminar | August 25-26, 2021

* For one Registration $1299

Regulatory Compliance for Dietary Supplements in the US, EU and Canada
Speaker

Travis Austin MacKay
Director of Regulatory Affairs, Plexus Worldwide

Location

Location : Virtual Seminar | August 26-27, 2021

* For one Registration $1499

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

Barry A. Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Location

Location : Virtual Seminar | August 26-27, 2021

* For one Registration $1999

Technical Writing for Pharma, Biotech and Medical Devices
Speaker

Mark Powell
Director, Mark Powell Scientific Limited

Location

Location : Virtual Seminar | September 9-10, 2021

* For one Registration $1299

Change Control Best Practices - Avoiding Unintended Consequences of Changes
Speaker

Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance

Location

Location : Virtual Seminar | September 16-17, 2021

* For one Registration $1499

Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Speaker

Charity Ogunsanya
CEO and Founder, Pharmabiodevice Consulting LLC

Location

Location : Virtual Seminar | September 16-17, 2021

* For one Registration $1299

PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
Speaker

Cynthia Brysch
Senior Principal Consultant, PTS Advance

Location

Location : Virtual Seminar | September 16-17, 2021

* For one Registration $1899

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
Senior IVD consultant, Biologics consulting Inc

Location

Location : Virtual Seminar | September 16-17, 2021

* For one Registration $1899

Method Development and Validation for Assays Supporting Testing of Biologics
Speaker

Gwen Wise-Blackman
Principal Consultant, Gwen Wise-Blackman Consulting, LLC

Location

Location : Virtual Seminar | September 22-23, 2021

* For one Registration $1899

 

 

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