The FDA Inspection: Best Practices for Preparation, Behavior, and Response

MP3 Download This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA

Jeff Kasoff

$179

Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program

MP3 Download This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program

Frank Stein

$429

Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs

MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle

Carolyn Troiano

$392

Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance

MP3 Download This webinar will conforms to the new ISO 62366 standard and the new FDA Guidance document.

Edwin Waldbusser

$265

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

$199

Power Analysis for Sample Size Calculations

MP3 Download In this webinar speaker will explain how to put the power analysis techniques to use will help to assure that you’ll collect a large enough sample

Elaine Eisenbeisz

$249

Management Review to ensure a Suitable and Effective Quality Management System

MP3 Download this course, we’ll discuss how to improve awareness, focus, and a culture of quality

Susanne Manz

$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

€1.295

Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience

MP3 Download This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs)

Edwin Waldbusser

$229

Anti-Kickback, Fraud, Stark, and Marketing - Where are the Landmines?

MP3 Download This session will benefit all functional groups who have data protection responsibility, marketing responsibilities, or need to understand

William Mack Copeland

$299

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

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

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

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

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

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