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A risk based approach to GxP Compliant Laboratory Computerized Systems in the COVID-19 Era and Beyond
April 13-14 This hands-on seminar provides a practical, risk based approach to laboratory computerized system specification, verification, and implementation
Carolyn Troiano Carolyn Troiano
$1,295
FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges
June 2-3 , 2022 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
Computer System Validation Professional Certification Program
May 16-18, 2022 3 day CSV course will teach you how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$1,899
Good Clinical Practice (ICH GCP) Course
MP3 Download This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements
John E Lincoln John E Lincoln
$385
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
6 Hours Annual Online Human Error Certification Training Program
MP3 Download this training would provide tools that can be implemented and used after this event.
Ginette Collazo Ginette Collazo
$499
Supervising a Human Error Free Environment: You can do a Lot More than you Think
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 Ginette Collazo
$179
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
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
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
Post Market Surveillance - Complaint Handling and Medical Device Reporting
MP3 Download This webinar will cover the basics of complaint management and medical device reporting
Susanne Manz Susanne Manz
$229
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
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
FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar
MP3 Download This Course will explain how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$1,295
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
CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture
MP3 Download This Webinar presentation will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory
Roger Cowan Roger Cowan
$299
Cybersecurity - US FDA Requirements – New Course !
MP3 Download This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production
John E Lincoln John E Lincoln
$249
Introduction to Medical Device Quality System Regulations
MP3 Download Attendees will learn FDA’s expectations for the implementation and on-going operation of an effective medical device
Paul Larocque Paul Larocque
$265
Statistics for Process Control
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
$795
Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
MP3 Download This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management
Jeff Kasoff Jeff Kasoff
$249
Analytical Method Validation, Verification and Transfer
MP3 Download In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures
Kelly Thomas Kelly Thomas
$1,498
Preventing Human Error in the Life Sciences Virtual Seminar (4 hours)
MP3 Download This four hour virtual seminar, will explore the true causes and nature of human error, how human error should be investigated
Charles H. Paul Charles H. Paul
$2,995
How FDA trains its investigators to review CAPA and what should you do to prepare
MP3 Download This webinar will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar
Jeff Kasoff Jeff Kasoff
$249
Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology
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
$499
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
Computer System Validation for Cloud and COTS Applications–Live, Online Training
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
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
MP3 Download The seminar will provide attendees with a better understanding of responsibilities and gain a greater knowledge of the issues faced
David R. Dills David R. Dills
$1,299
Good Documentation Practices
MP3 Download This presentation will discuss the purpose of good documentation, what proper documentation looks like and a brief discussion of elements
David W. Husman David W. Husman
$199
Purchasing Controls and Receiving Acceptance for Medical Devices
MP3 Download This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products
Susanne Manz Susanne Manz
$229
Excel Spreadsheet Validation-Step-by-step guide to data integrity compliance
MP3 Download This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$199
FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
MP3 Download The objective of this live training webinar is to explore the NEW/REVISED Guidances for Industry on Pyrogen and Endotoxins Testing. FDA Training
Barry A. Friedman Barry A. Friedman
$249
Production and Process Controls for Medical Devices What You Need to Know
MP3 Download This webinar can help you prevent serious issues such as these. You’ll learn about FDA quality system regulation expectations, and how you can
Susanne Manz Susanne Manz
$249
The European PSMF
MP3 Download This course teaches you with evolution of the PSMF and the legislation concerning it for the EU, sections of the PSMF, annexes of the PSMF
Graeme Ladds Graeme Ladds
$249
Full Day Virtual Workshop Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst
MP3 Download This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated
Joy L. McElroy Joy L. McElroy
$695