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Courses

21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
July 08 describes exactly what is required for compliance with Part 11
David Nettleton David Nettleton
$190
Master Validation Plan - The Unwritten Requirements
July 09 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
Analytical Methods, Process, Equipment, Cleaning, and Sterilization Validation
July 09 Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al
John E Lincoln John E Lincoln
$199
FDA Regulations for Tobacco & Tobacco-Related Products – Computer System Validation (CSV), 21 CFR Part 11 (electronic records/signatures), Data Integrity & Compliance
Jul 15 You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA
Carolyn Troiano Carolyn Troiano
$199
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
July 16-17 In this course, you will learn the practical applications for ensuring regulatory compliance as required by FDA regulations
Karl M. Nobert Karl M. Nobert
$1,495
FDA Recalls - Before You Start, and After You Finish
July 29-30 This seminar will help you to Understand FDA's recall authority and policy
Kelly Thomas Kelly Thomas
$1,495
AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework
Jul 30 The use of Generitive AI in the Drug discovery and Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals - their risk-based framework.
John E Lincoln John E Lincoln
$199
Software Verification and Validation - The 10 Must Have Documents
Aug 05 The tougher FDA expects a company to develop and run a formal software V&V plan . The model presented here satisfies their requirements for all software/firmware/PLC V&V.
John E Lincoln John E Lincoln
$199
Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry
Aug 05-07 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company
Kelly Thomas Kelly Thomas
$1,895
Risk-based Computer System Validation; Reduce Costs and Avoid 483s
Aug 06-07 This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors
David Nettleton David Nettleton
$1,895
21 CFR Part 11 Compliance for SaaS/Cloud Application
Aug 06-07 This course benefits anyone that uses computer systems to perform their job functions and is ideal for professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors
David Nettleton David Nettleton
$1,895
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
Aug 06-07 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
$1,895
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
Aug 07 In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle
Carolyn Troiano Carolyn Troiano
$199
The 6 Most Common Problems in FDA Software Validation and Verification
Aug 14 This webinar covers the fundamentals of 21 CFR Part 11, software validation
David Nettleton David Nettleton
$190
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training
Aug 19 The objective of this live training webinar is to develop an understanding
Kelly Thomas Kelly Thomas
$299
The EU Clinical Trial Regulation - EU Filings & Registrations
Aug 20 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln John E Lincoln
$995
Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance
20 Aug This webinar will cover the FDA’s total product life cycle approach and FDA’s roles and responsibilities in regulating medical devices throughout their lifecycle. The US FDA has long promoted a Risk-Based Total Product Life Cycle (TPLC)
John E Lincoln John E Lincoln
$199
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
Drug, Device and Combination Product Development
Aug 25 Combination products are subject to a combination of CGMPs to form an "Operating System". This greatly increases compliance to the Combo Products CFMPs, 21 CFR 4. And recent problems have compounded supply chain issues.
John E Lincoln John E Lincoln
$199
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
FDA Inspection Seminar
Sep 03 - 04 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
2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
Sep 08-09 This 2 day seminar will go into the specifics of the REACH and RoHS regulations
Kelly Eisenhardt Kelly Eisenhardt
$1,895
Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements
Sep 09-10 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
Verification and Validation - Product, Equipment/Process, Software and QMS
Sep 11-12 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
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
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
$1,895
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
Sep 22-23 The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar
Barry A. Friedman Barry A. Friedman
$1,495
FDA Trends for Computer System Validation (CSV) Compliance and Enforcement
Sep 23 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
Supplier and Contract Manufacturer Management
Sep 24-25 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
$1,295
Analytical Methods Validation for FDA Compliance
Oct 07-09 In this course, general guideline for the determination of the analytical
Kelly Thomas Kelly Thomas
$1,895
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
Oct 21-23 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
Quality Control Laboratory Compliance - cGMPs and GLPs
Oct 21-22 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
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
GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries
MP3 Download GMP Auditing for the Pharmaceutical Industry
Kelly Thomas Kelly Thomas
$1,295
Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech
MP3 Download This Course will explain how to comply with key FDA and international CSV regulations
Carolyn Troiano Carolyn Troiano
$1,495
Changes to 21 CFR 820 - Device QSR to QMSR - Due February 02, 2026
MP3 Download This webinar will discuss what the new QMSR will require, by including a discussion of the Final Rule and its Preamble
John E Lincoln John E Lincoln
$199

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