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Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations
MP3 Download This webinar will help you understand in detail the new requirements for trial master files. You should attend this webinar if you are responsible for establishing or maintaining a TMF
Carolyn Troiano Carolyn Troiano
$249
FDA Compliance and Enforcement Trends focused on Data Integrity
MP3 Download This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits
Carolyn Troiano Carolyn Troiano
$249
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
$1,895
Computer System Validation for Cloud and COTS Applications
May 03-05 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
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
MP3 Download The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar is to explore raw materials and their requirements – issues and solutions.
Barry A. Friedman Barry A. Friedman
$1,496
Technical Writing for professionals in the life sciences
MP3 Download This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents
Charles H. Paul Charles H. Paul
$1,495
Preventing Human Error in the Life Sciences
MP3 Download This eight-hour 4-hour per day virtual seminar, will explore the true causes and nature of human error
Charles H. Paul Charles H. Paul
$1,295
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
MP3 Download This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada and discuss how to verify that products
Travis Austin MacKay Travis Austin MacKay
$1,895
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
$299
Design Controls for Medical Devices
MP3 Download This 3-hour webinar will cover the basics of design controls for medical devices
Susanne Manz Susanne Manz
$299
FDA Compliance and Mobile Applications Best Practices for Ensuring Compliance
MP3 Download You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed
Carolyn Troiano Carolyn Troiano
$249
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
MP3 Download The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
David Nettleton David Nettleton
$1,995
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
"Zero Defects" and the cGMPs - Pros and Cons
MP3 Download The last few years have seen several major "names" in drugs and devices stumble over quality and cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution
John E Lincoln John E Lincoln
$199
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
MP3 Download Learn the basic overview of the original medical device Quality Management System
John E Lincoln John E Lincoln
$229
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
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
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