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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
Best Practices in Preparation for an FDA Computer System Audit
MP3 Download The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies
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
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
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
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
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
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
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
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
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
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
Purchasing Controls, Receiving Inspection, and Supplier Audit – what to do during a global pandemic
MP3 Download This webinar will provide insights into how to use remote auditing techniques to minimize the risk and maximize the benefits of conducting audits
Susanne Manz Susanne Manz
$249
Analytical Method Validation and Transfer
MP3 Download This course will provide a thorough review of regulatory guidelines on method validation and transfer
Kelly Thomas Kelly Thomas
$229
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
$199
Human Error Solutions: How we reduced 60% of human errors in less than a year, a Case
MP3 Download Join this session by expert speaker Ginette Collazo, where she will discuss how by redesigning the training function and by focusing on the expected result
Ginette Collazo Ginette Collazo
$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
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
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
Essentials of Validation - IQ, OQ, PQ
MP3 Download This course will cover the validation essentials for medical device manufacturers
Susanne Manz Susanne Manz
$179