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FDA Regulatory Compliance Training

Online FDA regulatory compliance trainings, webinars on FDA regulations, regulatory trends and FDA guidance from World Compliance Seminars.


Courses

Post-Market-Surveillance EU and US - What is in the store for you?
Oct 27 The course is ideal for regulatory, quality, and clinical teams seeking to ensure compliance and efficiency across both regulatory landscapes.
Frank Stein Frank Stein
$199
Good Laboratory Practices (GLP) for Nonclinical Laboratory Studies
Oct 29 This webinar will define what are the US FDA's expectation for proper laboratory practices, systems, equipment usage, and documentation / record-keeping
John E Lincoln John E Lincoln
$299
Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
Oct 29-30 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
Verification and Validation - Product, Equipment/Process, Software and QMS
Oct 30 - 31 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
$1,495
GMPs for MICROBIOLOGISTS — The Manufacturing Environment
Nov 04 The objective of this live, interactive Executive Conference Corp (ECC) webinar is to obtain an enhanced understanding
Barry A. Friedman Barry A. Friedman
$395
Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry
Nov 04-06 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company
Kelly Thomas Kelly Thomas
$1,895
Computer System Validation ( CSV) 3 Day Seminar
Nov 04-06 3 day CSV course will teach you how to comply with key FDA and international CSV
Carolyn Troiano Carolyn Troiano
$1,895
Software Verification and Validation - The 10 Must Have Documents
Nov 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
QMS 101: Quality Management System Guide
Nov 05 This webinar discusses the key parts of ISO 9001, especially how it applies to manufacturing. However, its principles can, and are, used in many different business activities
John E Lincoln John E Lincoln
$199
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training
Nov 06 The objective of this live training webinar is to develop an understanding
Kelly Thomas Kelly Thomas
$299
The 6 Most Common Problems in FDA Software Validation and Verification
Nov 13 This webinar covers the fundamentals of 21 CFR Part 11, software validation
David Nettleton David Nettleton
$190
CRO, CDMO and Non-Clinical Vendor Management Fundamentals
Nov 12 The medical products supply chain is a complex global enterprise. Regulatory agencies are increasingly recognizing that fact and incorporating
John E Lincoln John E Lincoln
$299
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
Nov 12-13 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
cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA
Nov 13 This webinar will cover the key areas of how ICH Q7 was established, it's goals and object
Kelly Thomas Kelly Thomas
$695
Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) – A Technical Documentation Training
Nov 13 This seminar will examine the existing and proposed requirements for the U.S. FDA
John E Lincoln John E Lincoln
$595
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Nov 17-18 The lifecycle concept, new to these Guidance, link product and process development, qualification
Barry A. Friedman Barry A. Friedman
$1,295
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Nov 18-20 This eight-hour vendor qualification audit training will help you improve
Kelly Thomas Kelly Thomas
$1,895
Master Validation Plan - The Unwritten Requirements
Nov 18 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
$695
Validation of FDA-Regulated Systems that Incorporate Artificial Intelligence (AI) and Machine Learning (ML)
Nov 18 In this webinar, you will learn just how AI can increase efficiency and effectiveness of software development life cycle
Carolyn Troiano Carolyn Troiano
$249
Preparing the CMC Section for NDAs/INDs/CTDs
Nov 21 This webinar will discuss current US Federal law on NDAs and INDs and CMC and other associated requirements for getting a new drug through the US FDA review process and to market in the USA.
John E Lincoln John E Lincoln
$299
Global Regulatory Requirements for Drug Safety & Pharmacovigilance
Nov 25 This training course is designed to give pharmaceutical and biologic companies
Steve Jolley Steve Jolley
$749
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
Nov 20-21 The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar
Barry A. Friedman Barry A. Friedman
$1,495
EU Clinical Trial Regulation 536/2014: Compliance, Implementation & Best Practices
Nov 25 This course covers the requirements for conducting Clinical Studies across the EU
John E Lincoln John E Lincoln
$995
FDA Inspection Seminar
Dec 02 - 03 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
Supplier and Contract Manufacturer Management
Dec 03 - 04 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
Microbiological Rapid Method Sterility Testing (RMT) of Short Dated and Other Products
Dec 03 The objective of this live, interactive training Executive Conference Corp webinar
Barry A. Friedman Barry A. Friedman
$395
GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials
03 Dec This webinar will provide test scripts and rationale for a "model" for internal /self-audits.
John E Lincoln John E Lincoln
$299
2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
Dec 04-05 This 2 day seminar will go into the specifics of the REACH and RoHS regulations
Kelly Eisenhardt Kelly Eisenhardt
$1,895
Excel Spreadsheet Validation for Part 11 to Eliminate 483s
Dec 09 This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$190
Efficient Batch Record Design & Review Training: GMP Compliance & FDA Requirements
Dec 10-11 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
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course
Dec 11-12 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
$1,495
Human Error Prevention (HEP) - Risk Factors and Strategies
Dec 15 This presentation focuses on the use of HEP, HRA and HEART tools to add additional review areas to Risk Management and Human Factors Analysis to effect beneficial
John E Lincoln John E Lincoln
$595
Statistical Process Control (SPC) Training
MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality
Elaine Eisenbeisz Elaine Eisenbeisz
$995
Biostatistics for the Non-Statistician
MP3 Download this course will have understanding of concepts and statistical methods required in pharmaceutical, biological and medical device.
Elaine Eisenbeisz Elaine Eisenbeisz
$1,895
Cybersecurity - The Latest US FDA Requirements
MP3 Download 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
$399
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
MP Download 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