GMP Environmental Monitoring for Pharmaceutical Clean Rooms

MP3 Download Attend this webinar to various US and international regulatory requirements, the testing requirements for the various clean room classifications

John E Lincoln

$249

What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections

MP3 Download This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities

Kelly Thomas

$499

US FDA Medical Device QSR, 21 CFR 820 and Quality Management System

MP3 Download Learn the basic overview of the original medical device Quality Management System

John E Lincoln

$229

Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

MP3 Download this webinar will cover all the items listed above, and more. If you want to improve your CAPA system, you cannot afford to miss this.

Jeff Kasoff

$199

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

$240

Quality by Design for Medical Devices Live Webinar

MP3 Download This webinar can help you create a design control process that is a competitive strength for your company.

Susanne Manz

$699

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

The European PSMF

MP3 Downoad 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

$199

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

2 Day Virtual Seminar on FDA Inspection Essentials in 2021

MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol

Danielle DeLucy

$1,295

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

$199

Drug Development: Key to Success from Concept to Commercialization

MP3 Download This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies who would like an understanding

Karl M. Nobert

$1,299

FDA Regulation of Artificial Intelligence/ Machine Learning

MP3 Download This webinar is not a programming course but will explain the present and future regulatory requirements for AI/ML

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

How to write SOP's that Avoid Human Error

MP3 Download This Webinar will discuss the primary cause of quality and production losses in many industries

Ginette Collazo

$199

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

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

$199

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

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

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