How to Analyze PQ Data with Multiple Populations/ Failure Modes using Minitab®
Jerry Phillips
90 Min
Product Id: 705281
This training will provide an understanding of graphical tools used to identify multiple populations or failure modes. Attendees will learn how to estimate product reliability for multiple populations using Minitab® v17.
Leadership in Manufacturing Contamination Control: The Microbiology Lab
T.C Soli
60 Min
Product Id: 701478
This webinar on Contamination Control will discuss, how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve problems like recurring micro failures, investigations, and ineffective CAPAs.
Post-market Surveillance - Clinical Evaluation and Risk Management
Daniel O Leary
90 Min
Product Id: 705402
This Post-market Surveillance (PMS) webinar will discuss in detail the clinical evaluation and risk management requirements as described in MedDev 2.7/1 Rev. 4, EN ISO 14971:2012 and EN ISO 14971:2012 standards and how they are related. It will also explain some of the recent changes in EU medical device regulations.
Sampling Plan for Quality Audits
Daniel O Leary
90 Min
Product Id: 702581
This webinar examines the issues in audit sampling and provides the answers one need to plan audit. It will help attendees understand the use of standard sampling plans in an audit including FDA’s QSIT sampling plans.
Solutions for Addressing Fungal and Bacterial Spore Outbreaks in Pharmaceutical, Biotech, and Medical Device Operations
Jim Polarine
90 Min
Product Id: 701766
This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations.
You have a BI or Sterility Failure - Now What?
Gerry O Dell
90 Min
Product Id: 701503
This webinar on sterility or bioburden test for medical devices will discuss about the various items that should be investigated to determine the root cause, when a failure occurs during a sterility test, and the follow up to the investigation.
Classifying Medical Devices - US and EU
Charles H Paul
60 Min
Product Id: 705045
The Medical Device Classification webinar explains the classification system in US and the EU.
How to Interpret Probability Plots
Jerry Phillips
90 Min
Product Id: 705161
This webinar explains what it means to be “normally distributed”, how to assess normality, how to test for normality, and how to transform non-normal data into normal data.
Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration
Jose Mora
90 Min
Product Id: 703373
This webinar will explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.
Medical Device Software Verification and Validation
Nancy Knettell
60 Min
Product Id: 705393
This webinar will teach you how to design, build and test medical device software in preparation for the successful 510k submissions. It will cover medical device software user requirements, software architecture, design, unit testing and more.
How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)
Angela Bazigos
90 Min
Product Id: 705488
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?
Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity
Edwin Waldbusser
60 Min
Product Id: 705432
This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.
Stability and Shelf Life of Medical Devices
Stephanie Cooke
90 Min
Product Id: 705485
This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.
How to Conduct a Human Factors Validation Following ISO 62366 and the 2016 FDA Guidance
Edwin Waldbusser
60 Min
Product Id: 705057
This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes
John Chapman
60 Min
Product Id: 700184
This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. It will provide practical guidance on achieving the CE mark. Medical devices sold into the European Union (EU) must comply with the applicable medical device directives and EU laws similar to FDA’s regulations.
Develop a Device Master Record that can assist with Device History Record Review
Mary Nunnally
60 Min
Product Id: 705328
This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.
Statistical Concepts of Process Validation
Daniel O Leary
90 Min
Product Id: 701630
This webinar will discuss the fundamental statistical concepts to perform an effective process validation. Attendees will learn best practices to comply with QSR and ISO 13485:2016 requirements for process validation.
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
Angela Bazigos
90 Min
Product Id: 703738
This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.
Risk Based Approach in cGMP - Quality Risk Management (QRM)
Shana Dressel
60 Min
Product Id: 705412
This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.
FDA Inspections: What Regulations Expect
Joy McElroy
90 Min
Product Id: 705346
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.