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Courses

The Most Common Problems in FDA Software Validation & Verification
MP3 Download This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models
John E Lincoln John E Lincoln
$189
Optimizing Efficiency: A Comprehensive Guide to 5S Principles
MP3 Download This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler, and organized
Ginette Collazo Ginette Collazo
$199
Validation of Artificial Intelligence (AI), Machine Language (ML), and other Superintelligence-Based Systems Regulated by FDA
MP3 Download During the webinar, we will discuss FDA's considerations for adapting its review process for AI-enabled medical devices that have the ability to evolve rapidly in response to new data
Carolyn Troiano Carolyn Troiano
$189
Through the Eyes of an Auditor
MP3 Download This webinar provides insight into the kinds of clues an auditor might use in determining what areas to focus on
Jose Mora Jose Mora
$199
Trial Master File and Clinical Data Management Regulated by FDA
MP3 Download This FDA compliance training will cover in detail the new requirements for trial master files
Carolyn Troiano Carolyn Troiano
$189
Risk Management of Raw Materials in a GMP Environment
MP3 Download The live training webinar will explore the number of lots required to be tested before reduced testing might occur
Barry A. Friedman Barry A. Friedman
$1,199
Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements
MP3 Download In this webinar he will also discuss the consideration of the FDA’s concerns over which device functions
John E Lincoln John E Lincoln
$198
Useful Statistical Methods for Defining Product and Process Specifications
MP3 Download This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications
Steven Wachs Steven Wachs
$399
FDA's Latest Guidance for Cybersecurity for Medical Devices: Quality Management System and Premarket Submission Considerations
MP3 Download This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products
Carolyn Troiano Carolyn Troiano
$199
Stability Studies & Estimating Shelf Life
MP3 Download This webinar discusses the steps to design a stability study and analyze the results to estimate the product's shelf life
Steven Wachs Steven Wachs
$199
Corrective and Preventive Action (CAPA) - Principles of Lean Documents and Lean Configuration
MP3 Download This webinar presents a fresh new approach based upon solid principles and proven practices
Jose Mora Jose Mora
$199
Statistical Process Control (SPC) Training
This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality
Elaine Eisenbeisz Elaine Eisenbeisz
$895
Traditional Computer System Validation and More Novel Computer Software Assurance (CSA): Finding the Best Approach
MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry
Carolyn Troiano Carolyn Troiano
$199
Avoid Warning Letters in View of the U.S. FDA's Stated Goal
MP3 Download FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
John E Lincoln John E Lincoln
$199
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
MP3 Download This web presentation presents an overview of FDA’s 3 major regulations
John E Lincoln John E Lincoln
$199
GMPs for MICROBIOLOGISTS — The Manufacturing Environment
Feb 06 The objective of this live, interactive Executive Conference Corp (ECC) webinar is to obtain an enhanced understanding
Barry A. Friedman Barry A. Friedman
$386
GMP master class – get it right to avoid compliance issues
MP3 Download This training will provide foundation to your GMP training.
Charles H. Paul Charles H. Paul
$1,295
Project Management for FDA-Regulated Companies in the Postpandemic World: Are You Ready for New Approaches and Methods?
MP3 Download This webinar will provide valuable guidance to regulated companies in development
John E Lincoln John E Lincoln
$249
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall for FDA-Regulated Computer Systems and Software
MP3 Download This webinar will include a comparison of the Agile and Waterfall methodologies, along with the pros and cons of each
Carolyn Troiano Carolyn Troiano
$189
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
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 John E Lincoln
$199
Risk Management for Medical Devices per ISO 14971
MP3 Download This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview
Jose Mora Jose Mora
$199
Preparing for and Managing Successful FDA Inspections
Sep 03-04 This seminar, you will learn how to properly alert key members that an investigator
Danielle DeLucy Danielle DeLucy
$1,295
Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States
Jan 18 Dietary Supplement companies must ensure that any product claims they make are “truthful and not misleading” under FDA and FTC regulations
Travis Austin MacKay Travis Austin MacKay
$399
Data Integrity -- US FDA Requirements
MP3 Download This webinar will focus on the key issues raised by the FDA, not just for products
John E Lincoln John E Lincoln
$287
Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense
MP3 Download You will learn the why and how of the scientific method, and how to view the world
Elaine Eisenbeisz Elaine Eisenbeisz
$299
Efficient Batch Record Review and Product Release Course
MP3 Download Duration 240 Minutes
Danielle DeLucy Danielle DeLucy
$599
How to write SOP's that Avoid Human Error
MP3 Download This Webinar will discuss the primary cause of quality and production losses in many industries
Ginette Collazo Ginette Collazo
$199
Controlling Human Error in the manufacturing floor
MP3 Download This course offers practical approaches and tools to address human performance issues in GMP related environments
Ginette Collazo Ginette Collazo
$299
Statistical Process Control (SPC) One Day Masterclass
MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products
Elaine Eisenbeisz Elaine Eisenbeisz
$996
FDA Compliance and Enforcement Trends focused on Data Integrity
MP3 Download This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits
Carolyn Troiano Carolyn Troiano
$249
2024 Human Error Prevention & GMP Training Course - New
MP3 Download this training would provide tools that can be implemented and used after this event.
Ginette Collazo Ginette Collazo
$499
Good Clinical Practice (ICH GCP) Course : Core Requirements, Expectations and Challenges
MP3 Download This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements
John E Lincoln John E Lincoln
$595
FDA's Recent Regulation on the Use of Social Media - What It Is, How to Analyze It, Make It Work for You
MP3 Download This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products
Carolyn Troiano Carolyn Troiano
$249
FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You
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 Karl M. Nobert
$1,295
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
MP3 Download This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3
John E Lincoln John E Lincoln
$499
Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements
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 John G. Lanese
$399

Bundles

GMP Laboratory Control Professionals Certification Program
WCS 6-part GMP Laboratory Control Certification program provides the key principles and tools required to become a GMP Laboratory Control Professional.
Courses: 6
$1,295
Sterilization Professionals Certification Program
WCS 5-Part Sterilization Professional Certification program provides detailed training on the key principals and tools required to become a Sterilization Professional
Courses: 5
$1,495
Pharmacovigilance Certification
Pharmacovigilance Online Courses & Certifications
Courses: 2
$3,995
Good Manufacturing Practices (GMP) Certification Course
Online GMP Training courses
Courses: 4
$1,495
FDA Inspection Readiness Certification Program
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations.
Courses: 7
$1,495
US Dietary Supplements Certification
US Dietary Supplements Virtual Course Online
Courses: 3
$3,995
Lyophilization Basics for Pharmaceuticals
8 hrs Instructor-led Virtual Seminar -Lyophilization Pharmaceutical Course
Courses: 1
$1,295