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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 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
$1,495
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
MP3 Download 2 Day Virtual Seminar
Karl M. Nobert Karl M. Nobert
$1,395
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
Death by CAPA - Does your CAPA Program need a CAPA?
MP3 Download This seminar will cover regulatory expectations, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls
Susanne Manz Susanne Manz
$850
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
Full Day Virtual Seminar on Fundamentals of Pharmacokinetics
MP3 Download The course will describe the processes that a drug undergoes after administration such as the absorption
Dr. Stefano Persiani Dr. Stefano Persiani
$795
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
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
Extractables & Leachable in Drug Development
MP3 Download In this webinar expert speaker Stefano Persiani will focus on the basics of an effective extractables and leachables program
Dr. Stefano Persiani Dr. Stefano Persiani
$199
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
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 expectations of major health care regulators that are applicable to "virtual" companies
Kelly Thomas Kelly Thomas
$1,495
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
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
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