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Courses

21 CFR Part 11 - Compliance for Electronic Records and Signatures
MP3 Download This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security
Edwin Waldbusser Edwin Waldbusser
$189
Good Manufacturing Practices (GMP) Online Course
MP3 Download Our 4 Half-days long GMP training will equip you to increase your efficiency and strengthen your skills for a stellar career in the industry. Whether you want to level up your designation or become an entrepreneur, the credibility of a GMP course will only add stars to your portfolio.
Kelly Thomas Kelly Thomas
$1,995
Audit Trails - Critical to Support FDA 21 CFR Part 11 and Data Integrity Compliance
MP3 Download You’ll learn an approach to both 21 CFR Part 11 and data integrity compliance understanding what FDA expects stakeholders in industry to do. There a few simple suggestions that can streamline validation activities related to all of these key areas.
Carolyn Troiano Carolyn Troiano
$189
Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
MP3 Download This webinar will conforms to the new ISO 62366 standard and the new FDA Guidance document.
Edwin Waldbusser Edwin Waldbusser
$189
Quality Control Laboratory Compliance - cGMPs and GLPs Course - What Regulatory, Compliance & Quality Professionals Need to Know
MP3 Download This course will provide an overview of the Regulatory requirements governing QC Labs to ensure compliance with cGMP and GCP
Kelly Thomas Kelly Thomas
$1,295
Multiple Linear Regression, Logistic Regression, and Survival Analysis
MP3 Download This seminar provides in-depth training on multiple regression, logistic regression, and Cox regression, equipping you with the essential tools to analyze complex data sets accurately and efficiently.
Elaine Eisenbeisz Elaine Eisenbeisz
$795
FDA Regulation of Artificial Intelligence/ Machine Learning
MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML
Edwin Waldbusser Edwin Waldbusser
$189
Medical Device Software Validation Meeting FDA Regulations
MP3 Download This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product
Edwin Waldbusser Edwin Waldbusser
$189
How to Prepare for and Host an FDA Inspection and Respond to 483's
MP3 Download This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview
Edwin Waldbusser Edwin Waldbusser
$189
Basic GMP Training for the QC Laboratory
MP3 Download This course will provide participants with an understanding of how to effectively handle out-of-specification
Kelly Thomas Kelly Thomas
$1,295
Understanding How Quality Management Works
MP3 Download This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how most QMS' requirements build upon that foundation
John E Lincoln John E Lincoln
$189
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit
Michael Ramcharan Michael Ramcharan
$1,295
2024 Human Error Prevention & GMP Masterclass
Latest FDA Regulatory Requirements & Most Common GMP Issues Caused by Human Error
Ginette Collazo Ginette Collazo
$595
FDA Compliance and Laboratory Computer System Validation
MP3 Download This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco
Carolyn Troiano Carolyn Troiano
$189
P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3
MP3 Download This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs
John E Lincoln John E Lincoln
$189
2024 Toxic Substance Control act (TSCA) Basics
MP3 Download This is a one (1) day training course on the Toxic Substance Control Act and the latest developments for 2023
Kelly Eisenhardt Kelly Eisenhardt
$899
How to Conduct a Human Factors Usability Validation
MP3 Download This Webinar will explain why the FDA required a number of validation participants from each "distinct user population"
Jose Mora Jose Mora
$189
Current Trends in FDA Compliance and Enforcement for Regulated Computer Systems and Data
MP3 Download This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology
Carolyn Troiano Carolyn Troiano
$189
Building GMP Excellence: A Guide to Implementing Compliant Training Programs
MP3 Download The session discussed GMP regulations, agency expectations, training program responsibilities, new employee requirements, transferred employees, external service providers, events, skills qualification program, assessment, retraining, instructor qualifications, curriculum, documentation, and performance deviations.
Ginette Collazo Ginette Collazo
$189
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
MP3 Download This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs)
Kelly Thomas Kelly Thomas
$189
Risk-Based Validation of Spreadsheet Applications
MP3 Deownload This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries
Carolyn Troiano Carolyn Troiano
$189
FDA Regulation of Artificial Intelligence & Machine Learning
MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML
Jose Mora Jose Mora
$189
Human Error Gen- Human Error Mitigation: Strategies for Enhanced Performance
MP3 Download This training would provide tools that can be implemented and used after this event. These include practical tools
Ginette Collazo Ginette Collazo
$189
QMS 101: Quality Management System Guide
MP3 Download This webinar discusses the key parts of ISO 9001, especially how it applies to manufacturing. However, its principles can, and are, used in many different business activities
John E Lincoln John E Lincoln
$189
Project Management for Computer System Validation (CSV) to Improve FDA Compliance
MP3 Download We will cover the approach for validating/qualifying infrastructure components to FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions
Carolyn Troiano Carolyn Troiano
$189
Consumer Food and Health Attitudes
MP3 Download This webinar is based on information from the public domain, personal interviews, internet and social media discussions, news articles, and similar resources
John E Lincoln John E Lincoln
$189
Pharma 4.0 Focus - Newer Approaches and Technologies to Reduce Costs while Complying with FDA's 21 CFR Part 11, Data Integrity
MP3 Download The attendee will learn about ways to approach the computer system validation of any FDA-regulated system. There are traditional methods that have been followed for decades now, but these document-driven efforts
Carolyn Troiano Carolyn Troiano
$189
Device Changes, FDA Changes, and the 510(k)
MP3 Download In this webinar you will learn What approaches are required for product changes; for process changes
John E Lincoln John E Lincoln
$189
The FDA Inspection From SOP to 483
MP3 Download This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection
Jose Mora Jose Mora
$189
Veterinary Drug Approval Process and FDA Regulatory Guidance
MP3 Download This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government
Karl M. Nobert Karl M. Nobert
$1,295
Supervising a Human Error Free Environment: You can do a Lot More than you think
MP3 Download The session will discuss supervision approaches, near root causes and root causes for supervision related errors, and will address the 5 main elements of assuring an error free environment
Ginette Collazo Ginette Collazo
$199
Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)
MP3 Download In this two day workshop conference you will learn the requirements and expectation
Kelly Thomas Kelly Thomas
$1,843
Design History File (DHF), the Device Master Record (DMR) and the Device History Record (DHR) - 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
Quality Management 101: Enterprise Maintenance Professional's Guide
MP3 Download This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how a company's preventative and predictive maintenance programs can be enhances by the QMA requirements
John E Lincoln John E Lincoln
$189
Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3
MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development
John E Lincoln John E Lincoln
$189
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
MP3 Download This webinar will cover the key aspects of complying with 21 CFR Part 11 in both validating systems and maintaining them in a validated state throughout their entire life cycle.
Carolyn Troiano Carolyn Troiano
$189

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