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
The Drug Development Process from Concept to Market
Mark Powell
Director, Mark Powell Scientific Limited
Location : Virtual Seminar | July 27, 2021
21 CFR Part 11 Compliance for SaaS/Cloud Applications
David Nettleton
FDA Compliance Specialist, Computer System Validation
Location : Virtual Seminar | August 4-5, 2021
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 | August 4-5, 2021
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
Robert J. Russell
President and CEO, RJR Consulting, Inc
Location : Virtual Seminar | August 11, 2021
Internal Audit, Fraud Risk Assessment and Risk Management Annual Plan
Marna Steuart
CIDA, CFE, CPA, Controller
Location : Virtual Seminar | August 12-13, 2021
REACH and RoHS Compliance: Gain a Deeper Understanding
Kelly Eisenhardt
Co-Founder and Managing Director at BlueCircle Advisors LLC
Location : Virtual Seminar | August 12-13, 2021
Radiation Sterilization of Medical Products - Beyond the Basics
Martin Byrne,
Sterilization Consultant, Sterilization Illustrated
Location : Virtual Seminar | August 12-13, 2021
Coping with FDA Import Delays, including COVID-19, Expedited Imports and Detentions
Casper (Cap) Uldriks
Former Associate Center Director of FDA's CDRH
Location : Virtual Seminar | August 12-13, 2021
Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices
Susanne Manz
President and Principal Consultant, Manz Consulting Inc
Location : Virtual Seminar | August 19-20, 2021
Managing an Effective AML Compliance Program
Justin Muscolino
Head of North America Compliance Training, GRC Solutions Pty Ltd
Location : Virtual Seminar | August 23-24, 2021
Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance
Location : Virtual Seminar | August 25-26, 2021
Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
David L. Chesney
Principal and General Manager, DL Chesney Consulting, LLC (Former FDA Director)
Location : Virtual Seminar | August 25-26, 2021
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
Travis Austin MacKay
Director of Regulatory Affairs, Plexus Worldwide
Location : Virtual Seminar | August 26-27, 2021
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions
Barry A. Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena
Location : Virtual Seminar | August 26-27, 2021
Technical Writing for Pharma, Biotech and Medical Devices
Mark Powell
Director, Mark Powell Scientific Limited
Location : Virtual Seminar | September 9-10, 2021
Change Control Best Practices - Avoiding Unintended Consequences of Changes
Andrew Campbell
Pharmaceutical Consultant - Quality & Compliance
Location : Virtual Seminar | September 16-17, 2021
Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers
Charity Ogunsanya
CEO and Founder, Pharmabiodevice Consulting LLC
Location : Virtual Seminar | September 16-17, 2021
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
Cynthia Brysch
Senior Principal Consultant, PTS Advance
Location : Virtual Seminar | September 16-17, 2021
Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada
Haja Sittana El Mubarak
Senior IVD consultant, Biologics consulting Inc
Location : Virtual Seminar | September 16-17, 2021
Method Development and Validation for Assays Supporting Testing of Biologics
Gwen Wise-Blackman
Principal Consultant, Gwen Wise-Blackman Consulting, LLC
Location : Virtual Seminar | September 22-23, 2021
