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
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
MP3 Download describes exactly what is required for compliance with Part 11
- Course
- By David Nettleton
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
4 Hours Training Course on Medical Device Cybersecurity and FDA Compliance
This webinar will focus on cybersecurity of medical devices
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- By Carolyn Troiano
Best Practices To Help You Pass An FDA Computer System Validation Audit
MP3 Download Duration 90 Minutes
- Course
- By Carolyn Troiano
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
Computer System Validation ( CSV) 3 Day Seminar
MP3 Download 3 day CSV course will teach you how to comply with key FDA and international CSV
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- By Carolyn Troiano
Computer System Validation (CSV) and Software Testing: Applying an Agile Methodology vs. Waterfall
MP3 Download Duration 90 Minutes
- Course
- By Carolyn Troiano
Continuing to Audit during a Global Pandemic – How to Optimize Effectiveness and Minimize Risk
MP3 Download Duration 60 Minutes
- Course
- By Susanne Manz
Current regulatory thinking on Data Integrity in 2020
MP3 Download Duration 2 Days
- Course
- By Carolyn Troiano
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
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- By John E Lincoln
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
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
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- By Meena Chettiar
Excel Spreadsheets; everything you need to know to pass a Part 11 inspection
Jun 10 This session will make you a better Excel user, saving you time and costs
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- By David Nettleton
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.
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- By Carolyn Troiano
FDA Recalls - Before You Start, and After You Finish
July 29-30 This seminar will help you to Understand FDA's recall authority and policy
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- By Kelly Thomas
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
FDA's Recent Regulation on the Use of Social Media
MP3 Download -Duration 90 Minutes
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- By Carolyn Troiano
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
- Course
- By Casper (Cap) Uldriks
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
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
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
Good Manufacturing Practices Training | GMP Course
MP3 Download CT Duration 60 Minutes
- Course
- By Todd Graham
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
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
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- By Ginette Collazo
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
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
- Course
- By Susanne Manz
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
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
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
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
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
Medical Device Software 62304 Compliance
MP3 Download Duration 90 Minutes
- Course
- By Carolyn Troiano
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
Medical Device Software: Verification, Validation & Compliance
MP3 Download Duration 60 Minutes
- Course
- By Nancy Knettell
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
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
- Course
- By Susanne Manz
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
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
- Course
- By Susanne Manz
Quality Control Laboratory Compliance - cGMPs and GLPs
May 20-21 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
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
June 10-12 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
Regulatory Requirements for Registration of Medical Device Products in China
On Demand Webinar Duration 60 minutes
- Course
- By David R. Dills
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
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
Risk-based Design Control - The New Paradigm for Medical Device Design
MP3 Download- Duration 60 Minutes
- Course
- By Jose Mora
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
On Demand Webinar Duration 60 minutes
- Course
- By Jose Mora
Secrets for Writing Excellent SOPs for Medical Device QMS
MP3 Download Duration 90 Minutes
- Course
- By Susanne Manz
Sterilization of Pharmaceutical Products and Medical Devices During COVID19
MP3 Download Duration 60 Minutes
- Course
- By Carl Patterson
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
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
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- By Meena Chettiar
Understanding the Design Verification and Validation Requirements for Medical Devices
MP3 Download Duration 60 Minutes
- Course
- By Meena Chettiar
Understanding the Design Verification and Validation Requirements for Medical Devices
MP3 Download Duration 60 Minutes
- Course
- By Meena Chettiar
Upgrade Your Medical Device Recall Strategy
MP3 Download Duration 90 Minutes
- Course
- By Kelly Thomas
Validation Essentials for Medical Device Manufacturers – IQ, OQ, PQ
On Demand Webinar Duration 90 minutes
- Course
- By Susanne Manz