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Courses

Global Regulatory Requirements for Drug Safety & Pharmacovigilance
MP3 Download This training course is designed to give pharmaceutical and biologic companies
Steve Jolley Steve Jolley
$895
Excel Spreadsheets; everything you need to know to pass a Part 11 inspection
This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$190
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
Barry A. Friedman Barry A. Friedman
$1,495
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
MP3 Download This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pha
Kelly Thomas Kelly Thomas
$199
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
MP3 Download The lifecycle concept, new to these Guidance, link product and process development, qualification
Barry A. Friedman Barry A. Friedman
$1,495
Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) – A Technical Documentation Training
Jun 26 This seminar will examine the existing and proposed requirements for the U.S. FDA
John E Lincoln John E Lincoln
$595
Technical Writing for Technical Personnel (In a Regulated Industry)
MP3 Download Technical writing is a specialized form of writing often used by an organization's SME"s
John E Lincoln John E Lincoln
$199
FDA & OSHA Warehouse Requirements
MP3 Download The webinar will provide attendees with an overview of the FDA’s warehousing regulatory
Karl M. Nobert Karl M. Nobert
$399
The Quality System Regulation (cGMP 820) and the new QMSR
MP3 Download This webinar will discuss what the new QMSR will require. A key element is the incorporation of ISO 13485 into the new 820 by reference
John E Lincoln John E Lincoln
$199
Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control
MP3 Download In this webinar, we’ll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions
Carolyn Troiano Carolyn Troiano
$199
FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges
MP3 Download 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
$1,495
SPC (Statistical Process Control) / Control Charts
MP3 Download This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC)
John E Lincoln John E Lincoln
$199
Generative AI in Drug Discovery
MP3 Download The use of Generitive AI in the Drug Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals.
John E Lincoln John E Lincoln
$749
Drug Development: Key to Success from Concept to Commercialization
MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies
Karl M. Nobert Karl M. Nobert
$1,295
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
Charles H. Paul Charles H. Paul
$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
$1,495
Device Changes and the 510(k) -- Device Hardware and Software Requirements
MP3 Download This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k)
John E Lincoln John E Lincoln
$189
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
Travis Austin MacKay Travis Austin MacKay
$399
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
Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States
MP3 Download The Federal Food, Drug, and Cosmetic Act requires that a manufacturer of a dietary
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
US Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates What You Must Know and Do
MP3 Download 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
Pharmaceutical Document Management Training Course - A Global Regulatory Approach
MP3 Download This course is designed for individuals responsible for documentation writing and management in the pharmaceutical and related industries
Kelly Thomas Kelly Thomas
$1,895
cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA
MP3 Download This webinar will cover the key areas of how ICH Q7 was established, it's goals and object
Kelly Thomas Kelly Thomas
$595
NEW: " New Predetermined Change Control Plans (PCCP) for Medical Devices
MP3 Download This webinar will discuss the FDA's draft guidance recommendations for PCCPs as part of 510(k) or PMA submissions where future device changes are basically known
John E Lincoln John E Lincoln
$189
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
MP3 Download The attendee will learn a simple way to address both data integrity and Part 11 aspects of the system, focusing on risk and critical thinking
Carolyn Troiano Carolyn Troiano
$895
Introduction to Computer System Validation
MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology
Carolyn Troiano Carolyn Troiano
$1,295
Biostatistics for the Non-Statistician
Sep 16-18 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$1,495
Inspection and Audit Readiness Training for Medical Device Manufacturers
MP3 Download This webinar will focus on how to prepare domestic and foreign medical device manufacturers selling to the U.S. to recognize and prepare for FDA pre- and post-market inspections
John E Lincoln John E Lincoln
$545
Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)
MP3 Download This seminar will describe the requirements, the dos and don’ts commonly
John C. Fetzer John C. Fetzer
$1,495
CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
MP3 Download Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations
John E Lincoln John E Lincoln
$199
GAMP® 5 Second Edition – The changes and its impacts that you should know
MP3 Download Attendees will learn how to adapt their current method of validating FDA-regulated computer systems to align with both GAMP®5, Second Edition
Carolyn Troiano Carolyn Troiano
$499
Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity
MP3 Download This has resulted in the FDA focusing on the subset of software functions dealing
John E Lincoln John E Lincoln
$199
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
MP3 Download This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations
Carolyn Troiano Carolyn Troiano
$495
Good Clinical Practices and Good Laboratory Practices
MP3 Download This webinar will examine the basic requirements of the GLPs and GCP’s and related / supporting requirements
John E Lincoln John E Lincoln
$199
All About Data Integrity by Design
MP3 Download The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next generation medicinal products and new business cases for established products
Carolyn Troiano Carolyn Troiano
$1,295

Bundles

GMP Laboratory Control Professionals Certification Program
WCS 6-part GMP Laboratory Control Certification program provides the key principles and tools required to become a GMP Laboratory Control Professional.
Courses: 6
$1,295
Sterilization Professionals Certification Program
WCS 5-Part Sterilization Professional Certification program provides detailed training on the key principals and tools required to become a Sterilization Professional
Courses: 5
$1,495
Pharmacovigilance Certification
Pharmacovigilance Online Courses & Certifications
Courses: 2
$3,995
Good Manufacturing Practices (GMP) Certification Course
Online GMP Training courses
Courses: 4
$1,495
FDA Inspection Readiness Certification Program
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations.
Courses: 7
$1,495
US Dietary Supplements Certification
US Dietary Supplements Virtual Course Online
Courses: 3
$3,995
Lyophilization Basics for Pharmaceuticals
8 hrs Instructor-led Virtual Seminar -Lyophilization Pharmaceutical Course
Courses: 1
$1,295