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Courses

Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations
Dec 11 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 Recalls - Before You Start, and After You Finish
Dec 12-13 this seminar will help you to Understand FDA's recall authority and policy
Kelly Thomas Kelly Thomas
$1,495
Global Regulatory Requirements for Drug Safety & Pharmacovigilance
Dec 12 This training course is designed to give pharmaceutical and biologic companies
Steve Jolley Steve Jolley
$995
GMP master class – get it right to avoid compliance issues
Dec 12-13 This training will provide foundation to your GMP training.
Charles H. Paul Charles H. Paul
$1,295
Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States
Dec 12 The Federal Food, Drug, and Cosmetic Act requires that a manufacturer of a dietary
Travis Austin MacKay Travis Austin MacKay
$399
FDA Computer System Validation ( CSV) Training 2 Days Virtual Seminar
Dec 13-14 This Course will explain how to comply with key FDA and international CSV regulations
Carolyn Troiano Carolyn Troiano
$1,295
The EU Clinical Trial Regulation - EU Filings & Registrations
Dec 14 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln John E Lincoln
$895
Estimating and Demonstrating Product Reliability What You Must Know and Do – Webinar
Jan 09 This webinar provides methods that allow the risks of field failures due to inadequate designs or misunderstanding
Steven Wachs Steven Wachs
$249
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
Jan 10 This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pha
Kelly Thomas Kelly Thomas
$287
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
Jan 17-18 Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit
Michael Ramcharan Michael Ramcharan
$1,295
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
Jan 18 This webinar describes exactly what is required for compliance with Part 11
David Nettleton David Nettleton
$299
FDA & OSHA Warehouse Requirements
Jan 18 The webinar will provide attendees with an overview of the FDA’s warehousing regulatory
Karl M. Nobert Karl M. Nobert
$287
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Jan 17-18 This webinar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles
John E Lincoln John E Lincoln
$1,895
Medical Device Process Validation Training for Professionals Current Trends & Your Questions Answered - Webinar
Jan 17 This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP
John E Lincoln John E Lincoln
$209
FDA Compliance and Clinical Trial Computer System Validation Course
Jan 18-19 In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.
Carolyn Troiano Carolyn Troiano
$1,295
FDA Best Audit Practices – get ready for the inspection that is coming
Jan 23 This webinar will begin by discussing and emphasizing the importance of truthfulness
Charles H. Paul Charles H. Paul
$249
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Jan 24-25 This eight-hour vendor qualification audit training will help you improve
Kelly Thomas Kelly Thomas
$1,295
Verification and Validation - Product, Equipment/Process, Software and QMS
Jan 24-25 This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation
John E Lincoln John E Lincoln
$1,295
Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices
Jan 24-25This virtual seminar will address those project management critical tasks within each project phase that must be performed
Charles H. Paul Charles H. Paul
$995
US Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates What You Must Know and Do
Jan 24 This 120 minute training will review the dietary supplement regulations and discuss how to verify that your products
Travis Austin MacKay Travis Austin MacKay
$399
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
Jan 25-26 The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar
Barry A. Friedman Barry A. Friedman
$1,895
510(k) and PMA Submissions Process
Jan 25 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
$249
Analytical Methods Validation for FDA Compliance
Jan 25-26 In this course, general guideline for the determination of the analytical
Kelly Thomas Kelly Thomas
$1,295
2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
Jan 29-30 This 2 day seminar will go into the specifics of the REACH and RoHS regulations
Kelly Eisenhardt Kelly Eisenhardt
$1,899
The Most Common Problems in FDA Software Validation & Verification
Jan 30 This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models
John E Lincoln John E Lincoln
$199
Conducting Successful Quality Audits: Best Practices for Managing Inspection Situations
Jan 30 In this 90-minute accredited training, you will learn the importance of having a good
Danielle DeLucy Danielle DeLucy
$249
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
Feb 01 This webinar will review the applicable regulations, walk you through real-life
Travis Austin MacKay Travis Austin MacKay
$399
GMPs for MICROBIOLOGISTS — The Manufacturing Environment
Feb 06 The objective of this live, interactive Executive Conference Corp (ECC) webinar is to obtain an enhanced understanding
Barry A. Friedman Barry A. Friedman
$249
Quality Control Laboratory Compliance - cGMPs and GLPs Course - What Regulatory, Compliance & Quality Professionals Need to Know
Feb 08-09 This course will provide an overview of the Regulatory requirements governing QC Labs to ensure compliance with cGMP and GCP
Kelly Thomas Kelly Thomas
$1,295
Excel Spreadsheets; everything you need to know to pass a Part 11 inspection
Feb 08 This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$287
FDA Inspection Seminar
Feb 08-09 This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter
David R. Dills David R. Dills
$1,895
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Feb 26-27 The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc
Barry A. Friedman Barry A. Friedman
$1,295
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
Feb 27 This web presentation presents an overview of FDA’s 3 major regulations
John E Lincoln John E Lincoln
$199
US FDA Labeling Requirements for Medical Devices
Mar 06 In this webinar, including some little known or controlled areas which are subject
John E Lincoln John E Lincoln
$269
The 6 Most Common Problems in FDA Software Validation and Verification
Mar 14 This webinar covers the fundamentals of 21 CFR Part 11, software validation
David Nettleton David Nettleton
$287
US Drug Safety and FDA Inspection Readiness
MP3 Download This training course is designed to give pharmaceutical and biologic companies operating in the US an introduction to the fundamental
Steve Jolley Steve Jolley
$895

Bundles

Test 1
Courses: 4
$1,000