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

$199

Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)

MP3 Download This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs)

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

$179

2 Day Virtual Seminar on REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance

MP3 Download This 2 day seminar will go into the specifics of the REACH and RoHS regulations, provide case studies and share lessons learned so your

Kelly Eisenhardt

$1,695

Identifying Sources of Process Unreliability Within Your Organization: You May be Surprised.

MP3 Download In this Webinar you will learn how to use Reality-Charting, The Model for Improvement, and Process Reliability Modeling

David W. Husman

$209

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

$199

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

$499

Best Practices for Deviation Training

MP3 Download -Duration 180 Minutes

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

$179

Cybersecurity - US FDA Requirements – New Course !

MP3 Download This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production

John E Lincoln

$240

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

$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

$179

Vaccine Patents in the Current Pandemic Climate Live Webinar

MP3 Download This presentation will discuss not only the global patenting issues facing vaccines but will also look at some of the challenges facing vaccine

Joanna Brougher

$199

Fired by Facebook - HIPAA and social media violations of HIPAA’s privacy requirements

MP3 Download Duration 60 Minutes

Mark Brengelman

$399

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

$179

Fundamentals of Good Manufacturing Practices – Developing a Compliance Mindset

MP3 Download This webinar will discuss the basic principles and requirements for Good Manufacturing Practices

David W. Husman

$199

Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment

MP3 Download This live training will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase

Barry A. Friedman

$299

Supervising a Human Error Free Environment: You can do a Lot More than you Think

MP3 Download How can we prevent human error? This 90 -minutes online course will discuss why supervision is so important in reducing and preventing human error

Ginette Collazo

$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

$299

Virtual Seminar on GAMP® Data Integrity 21 CFR Part 11 Training Course

MP3 Download This training course will provide a practical understanding of the requirement for a data governance framework

Carolyn Troiano

$695

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

$499

QA and Risk Management approaches when Managing Clinical Trial Data – New Course !

MP3 Download This presentation focuses on the role of QA in the Risk Management process when deciding on how data should be collected

Carolyn Troiano

$229

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

$399

Non-conforming Materials in a Medical Device Company – dealing with in-house to field issues

MP3 Download Join industry expert Susanne Manz to learn online the essentials of dealing with non-conforming material and performing effective failure

Susanne Manz

$399

Are you ready for your next regulatory inspection? On site or virtual in 2021

MP3 Download This webinar is a practical, hands-on course designed to provide FDA industry with information and tools required to prepare for and manage an FDA

Alan Golden

$399

Supplier Management: How to meet FDA QSR and ISO 13485 requirements in a cost effective manner

MP3 Download Duration 60 Minutes

Jeff Kasoff

$179

Cosmetic Ingredients: from Science to Practical Use

MP3 Download Duration 90 Minutes

Paolo Giacomoni

$199

Creating and Maintaining an Effective and Efficient Technical Training Program

MP3 Download Duration 180 Minutes

Ginette Collazo

$299

Developing an Effective CAPA Management and Root Cause Analysis System

MP3 Download Duration 180 Minutes

Danielle DeLucy

$499

The Healthcare Quality Improvement Act: Achieving Immunity in Your Peer Review Process

MP3 Download This webinar will discuss the Health Care Quality Improvement Act (HCQIA) in detail, including the standards that must be met to achieve immunity

William Mack Copeland

$199

Continuing to Audit during a Global Pandemic – How to Optimize Effectiveness and Minimize Risk

MP3 Download Duration 60 Minutes

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

$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

$389

Sunscreens: Their Importance and US Regulations

MP3 Download Duration 90 Minutes

Paolo Giacomoni

$199

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

$199

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 is to explore raw materials and their requirements – issues and solutions.

Barry A. Friedman

$1,295