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Courses

Purchasing Controls, Receiving Inspection, and Supplier Audit – what to do during a global pandemic
MP3 Download This webinar will provide insights into how to use remote auditing techniques to minimize the risk and maximize the benefits of conducting audits
Susanne Manz Susanne Manz
$249
Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage
MP3 Download This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management
Jeff Kasoff Jeff Kasoff
$249
How FDA trains its investigators to review CAPA and what should you do to prepare
MP3 Download This webinar will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar
Jeff Kasoff Jeff Kasoff
$249
FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
MP3 Download The objective of this live training webinar is to explore the NEW/REVISED Guidances for Industry on Pyrogen and Endotoxins Testing. FDA Training
Barry A. Friedman Barry A. Friedman
$249
Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements
MP3 Download This Webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning.
John E Lincoln John E Lincoln
$199
The European PSMF
MP3 Download This course teaches you with evolution of the PSMF and the legislation concerning it for the EU, sections of the PSMF, annexes of the PSMF
Graeme Ladds Graeme Ladds
$249
Full Day Virtual Workshop Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst
MP3 Download This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated
Joy L. McElroy Joy L. McElroy
$695
3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)
MP3 Download This webinar will review the regulatory requirements for investigating an OOS Investigation.
Danielle DeLucy Danielle DeLucy
$399
2 Day Virtual Seminar on FDA Inspection Essentials in 2022
MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol
Danielle DeLucy Danielle DeLucy
€1.295
What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation
MP3 DowIoad this webinar you will learn about Auditing EU-MDR and EU-IVDR Implementation. We’ll share insights on the importance of good project management
David R. Dills David R. Dills
$399
Pharmaceutical Compressed Air Quality GMP Requirements - What you need to know to meet FDA and Inte
MP3 Download This webinar will give you an understanding of the different types of contamination inherent in compressed air
Roger Cowan Roger Cowan
$199
FDA’s Ambitious Regulation of Social Media - New Course By FDA Investigator
MP3 Download This webinar teach us about social media platforms provide common ways to cross FDA’s legal boundaries for “misbranding” your product
Casper (Cap) Uldriks Casper (Cap) Uldriks
$229
3 Hrs Virtual Webinar on Aseptic Processing and Validation
MP3 Download This course will provide an overview of requirements for aseptic and bulk manufacturing operations, including facility design and contamination
Kelly Thomas Kelly Thomas
$299
3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC
MP3 Download This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software
Jose Mora Jose Mora
$399
4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance
This webinar will focus on cybersecurity of medical devices
Carolyn Troiano Carolyn Troiano
$695
Data Integrity and Data Governance for Computer Systems Regulated by FDA
MP3 Download This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation
Carolyn Troiano Carolyn Troiano
$240
Building a Compliant Laboratory – From Foundation to Business Excellence
MP3 Download In this webinar speaker will define compliance, provide a translation of regulations and guidance into user requirements .
David W. Husman David W. Husman
$199
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
MP3 Download This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend
Kelly Thomas Kelly Thomas
€1.295
Establishing a Robust Data Integrity Program
MP3 Download This webinar will detail a data integrity governance program and principles for defining quality and data integrity into processes and systems.
Kelly Thomas Kelly Thomas
$199
Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance
MP3 Download This training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive
Carolyn Troiano Carolyn Troiano
$179
FDA CDS Software Regulation:The Latest Guidance on Clinical Decision Support Software
MP3 Download This Webinar will discuss clinical decision support (CDS) software might be regulated as a medical device.
John E Lincoln John E Lincoln
$199
Best Practices for Deviation Training
MP3 Download -Duration 180 Minutes
Danielle DeLucy Danielle DeLucy
$399
Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries
MP3 Download New Root Cause Analysis Techniques and CAPA Management live webinar is for those in Operations, Facilities , Engineering and QA/QC
Meena Chettiar Meena Chettiar
$179
Managing Risk Within Your Supplier Management Program Live Webinar
MP3 Download In this webinar, we will unpack the latest FDA requirements for supplier quality assurance (SQA)
Tim Fischer Tim Fischer
$299
Compliant Management Controls Under 21 CFR 820 and ISO 13485
MP3 Download Best QSR and ISO 13485 requirements webinar for management controls, Organizational structure and Establishment of an internal audit program.
Jeff Kasoff Jeff Kasoff
$179
FDA’s Plan for Modernizing the 510(k) Pathway
MP3 Download This FDA Training online will explain Basic of US FDA’s Expectations for the 510(k), The Medical Device Safety Action Plan and 510(k)
John E Lincoln John E Lincoln
$179
Is My Data Abnormal? Normality Tests and Transformations Live Webinar
MP3 Download In this webinar, you will also learn tools and concepts to understand what makes a distribution normal and when a transformation of data
Elaine Eisenbeisz Elaine Eisenbeisz
$299
Webinar Analytical Method Validation and Transfer According to the New FDA Guidance
MP3 Download This course will prepare attendees with the knowledge and tools to plan and execute test method validation packages for the NDA
Kelly Thomas Kelly Thomas
$499
Post-Market Activities in the EU-MDR — A Detailed Analysis
MP3 Download Medical device training will review the new EU-MDR requirements governing Post Market Activities and discuss quality system approaches
Kelly Thomas Kelly Thomas
$399
Supplier Management: How to meet FDA QSR and ISO 13485 requirements in a cost effective manner
MP3 Download Duration 60 Minutes
Jeff Kasoff Jeff Kasoff
$179
Creating and Maintaining an Effective and Efficient Technical Training Program
MP3 Download Duration 180 Minutes
Ginette Collazo Ginette Collazo
$299
Developing an Effective CAPA Management and Root Cause Analysis System
MP3 Download Duration 180 Minutes
Danielle DeLucy Danielle DeLucy
$499
Continuing to Audit during a Global Pandemic – How to Optimize Effectiveness and Minimize Risk
MP3 Download Duration 60 Minutes
Susanne Manz Susanne Manz
$249
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
MP3 Download This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing
Roger Cowan Roger Cowan
$299
Knock, knock, who’s there? Are you ready for an FDA inspection in the COVID-19 Era and Beyond?
MP3 Download This webinar will help you manage inspections efficiently and effectively. You’ll learn about the FDA’s inspectional approach, focus areas
Susanne Manz Susanne Manz
$389
Overview of Pharmacovigilance Under COVID-19
MP3 Download This Pharmaceutical training online aims to demonstrate what the new guidances allow in terms of pharmacovigilance activities that can be relaxed
Graeme Ladds Graeme Ladds
$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: 2
$1,295