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Controlling Human Error in the manufacturing floor
MP3 Download This course offers practical approaches and tools to address human performance issues in GMP related environments
Ginette Collazo Ginette Collazo
$299
US Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates
MP3 Download This 120 minute training will review the dietary supplement regulations and discuss how to verify that your products are compliant
Travis Austin MacKay Travis Austin MacKay
$399
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course
MP3 Download The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product
Barry A. Friedman Barry A. Friedman
$1,295
CROs (Clinical Research Organizations) - Identification, Selection, and Management for Maximum Results & Value
MP3 Download This course will provide the attendees with all the specific methodology and management techniques to successfully outsource pharmaceutical programs
Kelly Thomas Kelly Thomas
$1,495
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
Drug Development: Key to Success from Concept to Commercialization
MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies who would like an understanding
Karl M. Nobert Karl M. Nobert
$1,295
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
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
$1,495
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
Data Integrity -- US FDA Requirements
MP3 Download This webinar will focus on the key issues raised by the FDA, not just for products and their manufacture, but expectations
John E Lincoln John E Lincoln
$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
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
MP3 Download This webinar will review the applicable regulations, walk you through real-life situations, help you address compliance, and provide practical strategies to mitigate enforcement actions
Travis Austin MacKay Travis Austin MacKay
$399
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
Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices
MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective
Charles H. Paul Charles H. Paul
€1.495
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
2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
MP3 Download This 2 day seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your
Kelly Eisenhardt Kelly Eisenhardt
$1,899
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
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
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