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Product image for 3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)

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.

Course•By Danielle DeLucy

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Product image for 4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance

4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance

This webinar will focus on cybersecurity of medical devices

Course•By Carolyn Troiano

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Product image for 21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections

describes exactly what is required for compliance with Part 11

Course•By David Nettleton

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Product image for EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

EU MDR Implementation and Transitioning to the Deadline: Essential Tasks to Complete

MP3 Download This 2-day virtual seminar will go into the specifics of the European Union Medical Device Regulation (EU MDR), provide case studies and share le

Course•By Kelly Thomas

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Product image for AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework

AI in Drug Discovery: Aligning with FDA's Latest Risk-Based Framework

MP3 Download The use of Generitive AI in the Drug discovery and Development Process. The US FDA's encouragement of AI technology in pharma development and clinicals - their risk-based framework.

Course•By John E Lincoln

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Product image for Best Practices To Help You Pass An FDA Computer System Validation Audit

Best Practices To Help You Pass An FDA Computer System Validation Audit

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

cGMP Regulatory Inspections - Through the Eyes of FDA, EMA and PMDA

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

Course•By Kelly Thomas

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Product image for Compliant Management Controls Under 21 CFR 820 and ISO 13485

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.

Course•By Jeff Kasoff

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Product image for Computer System Validation ( CSV) 3 Day Seminar

Computer System Validation ( CSV) 3 Day Seminar

Jan 27 - 29 3 day CSV course will teach you how to comply with key FDA and international CSV

Course•By Carolyn Troiano

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Product image for Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall

Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for Current regulatory thinking on Data Integrity in 2020

Current regulatory thinking on Data Integrity in 2020

MP3 Download Duration 2 Days

Course•By Carolyn Troiano

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Product image for Cybersecurity, Data Integrity, Part 11, and Required Software Validation

Cybersecurity, Data Integrity, Part 11, and Required Software Validation

MP3 Download This online training describes FDA Guidances on Cybersecurity and Data Integrity , FDA’s enforcement, Software Validation , CGMPs and Cloud

Course•By John E Lincoln

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Product image for Dealing with CAPA- Corrective and Preventive Actions in FDA Regulated Industries

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

Course•By Meena Chettiar

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Product image for DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements

DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements

MP3 Download / Online On Demand-Duration 180 Minutes

Course•By John E Lincoln

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Product image for Excel Spreadsheet Validation for Part 11 to Eliminate 483s

Excel Spreadsheet Validation for Part 11 to Eliminate 483s

MP3 Download This session will make you a better Excel user, saving you time and costs

Course•By David Nettleton

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Product image for FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

FDA Compliance and Clinical Trial Computer System Validation Core Requirements, Expectations and Challenges

MP3 Download In this two day Virtual Seminar you will learn about FDA's expectations for classifying, assessing the risk, testing, and validating a computer system used in clinical trial work.

Course•By Carolyn Troiano

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Product image for FDA Recalls - Before You Start, and After You Finish

FDA Recalls - Before You Start, and After You Finish

Jan 21-22 This seminar will help you to Understand FDA's recall authority and policy

Course•By Kelly Thomas

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Product image for FDA Regulation of Artificial Intelligence/ Machine Learning

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

Course•By Edwin Waldbusser

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Product image for FDA's Recent Regulation on the Use of Social Media

FDA's Recent Regulation on the Use of Social Media

MP3 Download -Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for FDA's Recent Regulation on the Use of Social Media - What It Is, How to Analyze It, Make It Work for You

FDA's Recent Regulation on the Use of Social Media - What It Is, How to Analyze It, Make It Work for You

MP3 Download This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products

Course•By Carolyn Troiano

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Product image for FDA’s Plan for Modernizing the 510(k) Pathway

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)

Course•By John E Lincoln

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Product image for Full Day Virtual Workshop Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst

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

Course•By Joy L. McElroy

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Product image for GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Tri

GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Tri

On Demand Webinar Duration 60 minutes

Course•By David R. Dills

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Product image for Good Manufacturing Practices Training | GMP Course

Good Manufacturing Practices Training | GMP Course

MP3 Download CT Duration 60 Minutes

Course•By Todd Graham

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Product image for How FDA trains its investigators to review CAPA and what should you do to prepare

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

Course•By Jeff Kasoff

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Product image for How to write SOP's that Avoid Human Error

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

Course•By Ginette Collazo

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Product image for Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense

Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense

MP3 Download You will learn the why and how of the scientific method, and how to view the world

Course•By Elaine Eisenbeisz

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Product image for Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

Jan 15 This webinar will discuss current US Federal law on the 510(k), IDE, DeNovo, and PMA and associated requirements for getting a new or substantially changed medical device through the US FDA review process and to market in the USA.

Course•By John E Lincoln

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Product image for Learn the Latest FDA Compliance and Mobile Applications Live Webinar

Learn the Latest FDA Compliance and Mobile Applications Live Webinar

MP3 Download This topic is focused on the use of mobile applications to process data regulated by FDA. These applications may be used to collect, analyze

Course•By Carolyn Troiano

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Product image for Learn the latest Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar

Learn the latest Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for Learn the latest webinar Software Validation Utilizing Principles of Lean Documents and Lean Configuration

Learn the latest webinar Software Validation Utilizing Principles of Lean Documents and Lean Configuration

24-Feb,2021 at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Course•By Jose Mora

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Product image for Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

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

Course•By Kelly Thomas

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Product image for Masterclass: 4 Keys to Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations

Masterclass: 4 Keys to Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations

MP3 Download Duration 120 Minutes

Course•By John G. Lanese

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Product image for Medical Device Software 62304 Compliance

Medical Device Software 62304 Compliance

MP3 Download Duration 90 Minutes

Course•By Carolyn Troiano

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Product image for Medical Device Software Validation Meeting FDA Regulations

Medical Device Software Validation Meeting FDA Regulations

MP3 Download This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product

Course•By Edwin Waldbusser

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Product image for Medical Device Software: Verification, Validation & Compliance

Medical Device Software: Verification, Validation & Compliance

MP3 Download Duration 60 Minutes

Course•By Nancy Knettell

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Product image for Medical software development and regulation - What to consider?

Medical software development and regulation - What to consider?

MP3 Download This compact 90-minute course provides a focused introduction to the development of medical software requirements and a deep understanding of the regulatory requirements resulting

Course•By Frank Stein

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Product image for Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic - Learn what FDA is really thinking on regulation and guidance documents

MP3 Download this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.

Course•By Kelly Thomas

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Product image for Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices

MP3 Download This virtual seminar will address those project management critical tasks within each project phase that must be performed

Course•By Charles H. Paul

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Product image for Quality Control Laboratory Compliance - cGMPs and GLPs

Quality Control Laboratory Compliance - cGMPs and GLPs

MP3 Download This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions

Course•By Kelly Thomas

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Product image for Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Regulatory Compliance for Dietary Supplements in the US, EU and Canada

Jan 15-16 This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada

Course•By Travis Austin MacKay

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Product image for Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements

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.

Course•By John E Lincoln

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Product image for Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance

Risk Management for AI in Medical Devices – FDA’s TPLC Management Draft Guidance

MP3 Download This webinar will cover the FDA’s total product life cycle approach and FDA’s roles and responsibilities in regulating medical devices throughout their lifecycle. The US FDA has long promoted a Risk-Based Total Product Life Cycle (TPLC)

Course•By John E Lincoln

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Product image for Risk Management for Medical Devices per ISO 14971

Risk Management for Medical Devices per ISO 14971

MP3 Download This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview

Course•By Jose Mora

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

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

Course•By Carolyn Troiano

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Product image for Risk-based Design Control - The New Paradigm for Medical Device Design

Risk-based Design Control - The New Paradigm for Medical Device Design

MP3 Download- Duration 60 Minutes

Course•By Jose Mora

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Product image for Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

On Demand Webinar Duration 60 minutes

Course•By Jose Mora

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Product image for Sterilization of Pharmaceutical Products and Medical Devices During COVID19

Sterilization of Pharmaceutical Products and Medical Devices During COVID19

MP3 Download Duration 60 Minutes

Course•By Carl Patterson

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

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

Course•By Ginette Collazo

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Product image for The EU regulations for digital medical devices with AI components - A basket full of requirements - What does a manufacturer need to consider?

The EU regulations for digital medical devices with AI components - A basket full of requirements - What does a manufacturer need to consider?

MP3 Download This seminar systematically guides you through the requirements for digital medical devices with AI components in the regulatory role of manufacturer and contract developer

Course•By Frank Stein

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Product image for Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies

Tips for setting up a Quality System to withstand FDA Audits for Medical Device and Pharmaceutical Companies

MP3 Download This webinar will provide a step by step approach and valuable tips for setting up a Quality System to withstand FDA Audits

Course•By Meena Chettiar

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Product image for Understanding the Design Verification and Validation Requirements for Medical Devices

Understanding the Design Verification and Validation Requirements for Medical Devices

MP3 Download Duration 60 Minutes

Course•By Meena Chettiar

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Product image for Understanding the Design Verification and Validation Requirements for Medical Devices

Understanding the Design Verification and Validation Requirements for Medical Devices

MP3 Download Duration 60 Minutes

Course•By Meena Chettiar

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Product image for Upgrade Your Medical Device Recall Strategy

Upgrade Your Medical Device Recall Strategy

MP3 Download Duration 90 Minutes

Course•By Kelly Thomas

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