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Courses

FDA Recalls - Before You Start, and After You Finish
Apr 01-02 This seminar will help you to Understand FDA's recall authority and policy
Kelly Thomas Kelly Thomas
$1,495
Generative AI in Drug Discovery
02 Apr 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
Master Validation Plan - The Unwritten Requirements
Apr 03 What is the FDA definition of "risk based" and how is it documented in the V&V test report. Additional recommended supporting systems / documentation
John E Lincoln John E Lincoln
$499
Cybersecurity - The Latest US FDA Requirements
Apr 03 This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production by update, the CAPA system, among others
John E Lincoln John E Lincoln
$295
SPC (Statistical Process Control) / Control Charts
Apr 08 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
FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges
Apr 09-10 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
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
Apr 09 describes exactly what is required for compliance with Part 11
David Nettleton David Nettleton
$190
Risk-Based Approach to IT Infrastructure Qualification, Compliance & Control
Apr 10 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
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
Apr 15 In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle
Carolyn Troiano Carolyn Troiano
$199
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training
Apr 16 The objective of this live training webinar is to develop an understanding
Kelly Thomas Kelly Thomas
$295
The Quality System Regulation (cGMP 820) and the new QMSR
Apr 22 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
The EU Clinical Trial Regulation - EU Filings & Registrations
Apr 22 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln John E Lincoln
$749
Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry
Apr 22 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company
Kelly Thomas Kelly Thomas
$1,895
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
Apr 23 This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pha
Kelly Thomas Kelly Thomas
$195
GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries
Apr 23-24 GMP Auditing for the Pharmaceutical Industry
Kelly Thomas Kelly Thomas
$1,295
Technical Writing for Technical Personnel (In a Regulated Industry)
May 06 Technical writing is a specialized form of writing often used by an organization's SME"s
John E Lincoln John E Lincoln
$199
Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) – A Technical Documentation Training
Apr 29 This seminar will examine the existing and proposed requirements for the U.S. FDA
John E Lincoln John E Lincoln
$595
Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements
May 07-08 In this accredited training, we will identify and discuss Master Batch Records (MBR), regulatory requirements, and key steps for issuance, batch record review, reconciliation, and final QA disposition
Kelly Thomas Kelly Thomas
$1,450
FDA Inspection Seminar
May 06-07 This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter
Kelly Thomas Kelly Thomas
$1,450
The 6 Most Common Problems in FDA Software Validation and Verification
May 13 This webinar covers the fundamentals of 21 CFR Part 11, software validation
David Nettleton David Nettleton
$190
2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
May 14-15 This 2 day seminar will go into the specifics of the REACH and RoHS regulations
Kelly Eisenhardt Kelly Eisenhardt
$1,899
Biostatistics for the Non-Statistician
May 19-20 this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$1,495
Supplier and Contract Manufacturer Management
May 20-21 This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification
Kelly Thomas Kelly Thomas
$1,449
FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
May 21 The seminar will cover what you need to do to prepare for an FDA audit, and also the importance and steps required to be certain you have audited all vendors of regulated systems appropriately.
Carolyn Troiano Carolyn Troiano
$499
Quality Control Laboratory Compliance - cGMPs and GLPs
May 20-21 This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions
Kelly Thomas Kelly Thomas
$1,450
Analytical Methods Validation for FDA Compliance
June 03-05 In this course, general guideline for the determination of the analytical
Kelly Thomas Kelly Thomas
$1,895
Excel Spreadsheets; everything you need to know to pass a Part 11 inspection
Jun 10 This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$190
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
June 10-12 This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada
Travis Austin MacKay Travis Austin MacKay
$1,895
Computer System Validation ( CSV) 3 Day Seminar
MP3 Download 3 day CSV course will teach you how to comply with key FDA and international CSV
Carolyn Troiano Carolyn Troiano
$1,895
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Aug 26-28 This eight-hour vendor qualification audit training will help you improve
Kelly Thomas Kelly Thomas
$1,895
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Sep 16-17 This seminar 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
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

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: 2
$1,295