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Alan Golden
Amanda McFarland
Andrew Campbell
Angela Bazigos
Barry A. Friedman
Ben Marandi
Carl Patterson
Carolyn Troiano
Casper (Cap) Uldriks
Charity Ogunsanya
Charles H. Paul
Cynthia Brysch
Danielle DeLucy
David Jones
David L. Chesney
David Nettleton
David R. Dills
David W. Husman
Dr. Afsaneh Motamed Khorasani
Dr. John M. Ryans
Dr. Michael Abitz
Dr. Stefano Persiani
Edwin Waldbusser
Elaine Eisenbeisz
Frank Stein
Ginette Collazo
Graeme Ladds
Jan Seal
Jeff Kasoff
Jim Sheldon-Dean
Joanna Brougher
John C. Fetzer
John E Lincoln
John G. Lanese
Jose Mora
Jose Mora
Joy L. McElroy
Karl M. Nobert
Kelly Eisenhardt
Kelly Thomas
Lisa Hardwick Thompson
Mark Brengelman
Mark Hughes
Mark Powell
Martin K. Behr
Meena Chettiar
Michael Esposito
Michael Ramcharan
Nancy Knettell
Nissan Cohen
Paolo Giacomoni
Paul Larocque
Peggy J. Berry
Peter Reijntjes
Rita Hoffman
Rob MacCuspie
Roger Cowan
Ron Snee
Speaker
Speaker for Biotechnology
Steve Jolley
Steven Laurenz
Steven Wachs
Susanne Manz
Theodore Sand
Tim Fischer
Todd Graham
Travis Austin MacKay
Trisha Paul
William Mack Copeland
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Courses
Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech
Available until
MP3 Download This Course will explain how to comply with key FDA and international CSV regulations
Carolyn Troiano
%
COMPLETE
$1,899
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Available until
MP3 Download The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc
Barry A. Friedman
%
COMPLETE
$1,295
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
Available until
MP3 Download This webinar describes exactly what is required for compliance with Part 11
David Nettleton
%
COMPLETE
$299
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
Available until
MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit
Michael Ramcharan
%
COMPLETE
$1,295
FDA Recalls - Before You Start, and After You Finish
Available until
MP3 Download this seminar will help you to Understand FDA's recall authority and policy
Kelly Thomas
%
COMPLETE
$1,495
Drug Development: Key to Success from Concept to Commercialization
Available until
MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies
Karl M. Nobert
%
COMPLETE
$1,495
Project Management for FDA-Regulated Companies in the Postpandemic World: Are You Ready for New Approaches and Methods?
Available until
MP3 Download This webinar will provide valuable guidance to regulated companies in development
John E Lincoln
%
COMPLETE
$249
Biostatistics for the Non-Statistician
Available until
MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz
%
COMPLETE
$1,295
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
Available until
MP3 Download This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada
Travis Austin MacKay
%
COMPLETE
$1,495
Preparing for and Managing Successful FDA Inspections
Available until
MP3 Download This seminar, you will learn how to properly alert key members that an investigator
Danielle DeLucy
%
COMPLETE
$1,295
cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA
Available until
MP3 Download This webinar will cover the key areas of how ICH Q7 was established, it's goals and object
Kelly Thomas
%
COMPLETE
$499
Statistical Process Control (SPC) Training and Certificate Online
Available until
MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality
Elaine Eisenbeisz
%
COMPLETE
$895
Excel Spreadsheets; everything you need to know to pass a Part 11 inspection
Available until
MP3 Download This session will make you a better Excel user, saving you time and costs
David Nettleton
%
COMPLETE
$287
Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense
Available until
MP3 Download You will learn the why and how of the scientific method, and how to view the world
Elaine Eisenbeisz
%
COMPLETE
$299
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training
Available until
MP3 Download The objective of this live training webinar is to develop an understanding
Kelly Thomas
%
COMPLETE
$299
Efficient Batch Record Review and Product Release Course
Available until
MP3 Download Duration 240 Minutes
Danielle DeLucy
%
COMPLETE
$599
Risk-Based Approach to Validating IT Infrastructure Used for FDA-Regulated Systems
Available until
MP3 Download In this webinar, we’ll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions
Carolyn Troiano
%
COMPLETE
$199
How to write SOP's that Avoid Human Error
Available until
MP3 Download This Webinar will discuss the primary cause of quality and production losses in many industries
Ginette Collazo
%
COMPLETE
$199
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
Available until
MP3 Download The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar
Barry A. Friedman
%
COMPLETE
$1,895
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
Available until
MP3 Download This Webinar will discuss the latest U.S. FDA and European Union requirements on Design History File, and Technical File/Design Dossier
John E Lincoln
%
COMPLETE
$199
Statistical Process Control (SPC) One Day Masterclass
Available until
MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products
Elaine Eisenbeisz
%
COMPLETE
$996
6 Hours Annual Online Human Error Certification Training Program
Available until
MP3 Download this training would provide tools that can be implemented and used after this event.
Ginette Collazo
%
COMPLETE
$499
FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You
Available until
MP3 Download this training will Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S. Pharmaceutical and Biotech.
Karl M. Nobert
%
COMPLETE
$1,295
Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements
Available until
MP3 Download In this live training webinar we will discuss the world-wide regulatory requirements for Annual product Reviews (or Product Quality Reviews).
John G. Lanese
%
COMPLETE
$399
Supervising a Human Error Free Environment: You can do a Lot More than you Think
Available until
MP3 Download How can we prevent human error? This 90 -minutes online course will discuss why supervision is so important in reducing and preventing human error
Ginette Collazo
%
COMPLETE
$179
Dealing with Out of Specification Test Results in FDA Regulated Industries
Available until
MP3 Download This webinar with a thorough knowledge on what is allowed and what is not allowed and areas that need to be looked at for a thorough investigation
Meena Chettiar
%
COMPLETE
$199
Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies
Available until
MP3 Download This webinar will provide a step by step approach and valuable tips for setting up a Quality System to withstand FDA Audits
Meena Chettiar
%
COMPLETE
$199
Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment
Available until
This live training will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase
Barry A. Friedman
%
COMPLETE
$299
Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Available until
MP3 Download this course we will review how quality systems helps in defining requirements for cleanrooms
Danielle DeLucy
%
COMPLETE
$491
The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam
Available until
MP3 Download This webinar will examine a variety of issues surrounding water in a facility to include the testing of each water source.
Barry A. Friedman
%
COMPLETE
$199
Non-conforming Materials in a Medical Device Company – dealing with in-house to field issues
Available until
MP3 Download Join industry expert Susanne Manz to learn online the essentials of dealing with non-conforming material and performing effective failure
Susanne Manz
%
COMPLETE
$399
Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents
Available until
MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
Kelly Thomas
%
COMPLETE
$1,495
FDA Regulation of Artificial Intelligence/ Machine Learning
Available until
MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML
Edwin Waldbusser
%
COMPLETE
$265
Learn the Latest FDA Compliance and Mobile Applications Live Webinar
Available until
MP3 Download This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze
Carolyn Troiano
%
COMPLETE
$299
Quality Control Laboratory Compliance - cGMPs and GLPs
Available until
MP3 Download This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions
Kelly Thomas
%
COMPLETE
$1,495
EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete
Available until
MP3 Download This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le
Kelly Thomas
%
COMPLETE
$3,999
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Bundles
Pharmacovigilance Certification
Courses: 2
$1,895
US Dietary Supplements Certification
US Dietary Supplements Virtual Course Online
Courses: 3
$1,195
Good Manufacturing Practices (GMP) Certification Course
Online GMP Training courses
Courses: 4
$1,985