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Implementing a Robust and Compliant Change Control Program
MP3 Download This Change Control training program will discuss regulatory expectations from the FDA, EU and ICH perspective
Kelly Thomas Kelly Thomas
$229
Medical Device Cybersecurity: What You Need to Know
MP3 Download In this webinar, you will learn just how cyberattacks threaten medical devices and how industry is currently responding to them
Carolyn Troiano Carolyn Troiano
$249
Analytical Method Validation Under Good Laboratory Practices (GLP) Live Webinar
MP3 Download Participants will understand - Is validation a regulated activity? When to pull the trigger for validation? Importance of suitability testing
John C. Fetzer John C. Fetzer
$189
Dealing with Out of Specification Test Results in FDA Regulated Industries
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 Meena Chettiar
$199
Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing
MP3 Download Computer Software Assurance (CSA) Approach to Validation: Using Agile and Automated Testing
Carolyn Troiano Carolyn Troiano
$249
Genotoxic Impurities in Drug Development
MP3 Download The webinar provides a general overview of the topic of genotoxic impurities and the approaches to safety evaluations.
Dr. Stefano Persiani Dr. Stefano Persiani
$199
Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies
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 Meena Chettiar
$199
FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges
MP3 Download In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.
Carolyn Troiano Carolyn Troiano
$1,295
Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment
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 Barry A. Friedman
$299
FDA Recalls - Before You Start, and After You Finish
MP3 Download this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.
Kelly Thomas Kelly Thomas
€1.595
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
MP3 Download The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc
Barry A. Friedman Barry A. Friedman
$1,295
Computer System Validation Professional Certification Program 3 Days
MP3 Download The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles
Carolyn Troiano Carolyn Troiano
$1,295
FDA’s Import Alerts
MP3 Download This webinar will provide attendees with background about FDA Import Alerts, examine why they are issues
Karl M. Nobert Karl M. Nobert
$299
Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
MP3 Download this course we will review how quality systems helps in defining requirements for cleanrooms
Danielle DeLucy Danielle DeLucy
$491
The Validation Master Plan - The Unwritten Requirements
MP3 Download This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S
John E Lincoln John E Lincoln
$199
Training Effectiveness: How to develop instruments to measure learning and reduce Human Errors for Life Sciences
MP3 Download We will discuss elements of the training programs like objectives, training content, training effectiveness, and other essential elements of a compliant training program.
Ginette Collazo Ginette Collazo
$249
Fundamental of Pharmacokinetics
MP3 Download The webinar will describe the processes that a drug undergoes after administration such as the absorption
Dr. Stefano Persiani Dr. Stefano Persiani
$199
The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam
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 Barry A. Friedman
$199
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
$1,495
Understanding Human Error in Manufacturing: Methodology for Investigations
MP3 Download This course offers practical approaches to address human performance issues in GMP-related environments
Ginette Collazo Ginette Collazo
$249
Non-conforming Materials in a Medical Device Company – dealing with in-house to field issues
MP3 Download Join industry expert Susanne Manz to learn online the essentials of dealing with non-conforming material and performing effective failure
Susanne Manz Susanne Manz
$399
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
$199
A risk based approach to GxP Compliant Laboratory Computerized Systems in the COVID-19 Era and Beyond
MP3 Download This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation
Carolyn Troiano Carolyn Troiano
$1,295
Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents
MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
Kelly Thomas Kelly Thomas
$1,495
A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls
MP3 Download This course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
Rita Hoffman Rita Hoffman
$1,295
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
$265
Learn the Latest FDA Compliance and Mobile Applications Live Webinar
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 Carolyn Troiano
$299
Computer System Validation for Cloud and COTS Applications
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
$1,495
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
$385
Excel Spreadsheets - Develop and Validate to Eliminate 483s
MP3 Download This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$199
Biostatistics for the Non-Statistician
MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
€4.665
GMP for Active Pharmaceutical Ingredients
MP3 Download This webinar reviews the requirements for good manufacturing practices for active pharmaceutical ingredients.
Paul Larocque Paul Larocque
$265
The Veterinary Drug Approval Process and FDA Regulatory Oversight
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
$2,995
Quality Control Laboratory Compliance - cGMPs and GLPs
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 Kelly Thomas
$1,495
EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete
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 Kelly Thomas
$3,999
Calculations for Process and Product Capability
MP3 Download This Webinar will focus on providing the information needed for attendees to know the appropriate measures and formulas
Elaine Eisenbeisz Elaine Eisenbeisz
$249