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GMPs for the Life Sciences – 12-Hour Virtual Seminar
MP3 Download This training will provide foundation to your GMP training.
Charles H. Paul Charles H. Paul
$1,295
PK/PD Studies in Drug Discovery and Development
MP3 Download The webinar reviews the general concepts and basic elements of pharmacokinetics, pharmacodynamics, and their correlation
Dr. Stefano Persiani Dr. Stefano Persiani
$199
A Culture of Quality is a Competitive Advantage in 2023
MP3 Download This webinar will help you to imbed a culture of quality throughout your organization. We will discuss concepts for creating a culture of quality
Susanne Manz Susanne Manz
$299
Complaint Handling Requirements
MP3 Download This 90-minute accredited course is intended to help you better understand and get familiar with the requirements for complaint files and key requirements
Danielle DeLucy Danielle DeLucy
$199
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
Statistical Process Control (SPC) One Day Masterclass
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
$996
510(k) and PMA Submissions Process
MP3 Download This webinar will detail the 510K and PMA processes as well as the EU directives comparing and contrasting those regulations
John E Lincoln John E Lincoln
$265
ISO 13485 – Medical Device Quality Management Systems
MP3 Download The ISO standard is also a valuable tool to the establishment, maintenance, and execution of the organization’s QMS
Charles H. Paul Charles H. Paul
$265
Fundamentals of Toxicology for the Pharmaceutical Industry
MP3 Download The webinar will cover these aspects that are relevant for non-toxicologists involved in drug development
Dr. Stefano Persiani Dr. Stefano Persiani
$199
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar
MP3 Download This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees
Carolyn Troiano Carolyn Troiano
$249
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
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
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
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
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'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
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
$1,295
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