![](/images/products/large/706006.jpg)
FDA Part 820 Basics - Everything you need to know to get your start-up Company Compliance
Denise Wrestler
90 Min
Product Id: 706006
In this webinar attendees will learn the basic understanding of the regulations listed within 21 CFR Part 820, how to apply regulations into your company documentation, describe the must-have systems required for your QMS, Also attendees will learn how to develop a checklist plan for ensuring all elements of the regulations are incorporated into your QMS, and better understand the scope of what will be needed to meet FDA requirements.
![](/images/products/large/704208.jpg)
CDISC Mapping 2: ODM, MindMaps and References
Sunil Gupta
90 Min
Product Id: 704208
This training program will highlight key differences between SDTM and ADaM models and process flows. It will also focus on key differences between the seven CDISC classes and on best practices to create Dataset.XML from SAS. Attendees will gain a better understanding of the structure and syntax of ODM-XML files as well.
![](/images/products/large/703443.jpg)
Process Challenge Device Development for EO Sterilization
Gerry O Dell
90 Min
Product Id: 703443
This webinar will discuss the role of Process Challenge Devices (PCDs) both during ethylene oxide (EO) validation and during routine processing. It will explain the difference in requirements for PCD during both the processes.
![](/images/products/large/704304.jpg)
Technical Writing for Medical Products: SOPs, Investigations and Change Records
Regina Fullin
60 Min
Product Id: 704304
In this training program, attendees will learn quick formatting tips that will make writing more readable and learn how to use formatting tools in a way to maximize the impact of their writing in an electronic system.
![](/images/products/large/704803.jpg)
Risk Analysis in Medical Device Design
Charles H Paul
60 Min
Product Id: 704803
This webinar will discuss the regulatory requirements and the processes, tools and techniques for conducting an effective risk and hazard analysis for medical devices as per FDA, FTA, FMEA, and FMECA guidelines.
![](/images/products/large/702766.jpg)
The Most Serious FDA 483s - How to Avoid Them
John E Lincoln
90 Min
Product Id: 702766
This webinar on avoiding serious FDA 483s will explain FDA's changed audit focus based on recent top 483 findings and provide practical tips on how to better prepare your company's internal audit program to avoid serious Form 483 observations.
![](/images/products/large/701138.jpg)
Failure Modes and Effects Analysis - An effective Risk Management Tool
John Chapman
60 Min
Product Id: 701138
This Medical device training will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
![](/images/products/large/704377.jpg)
FDA Regulations for Environmental Monitoring (EM) Program
Joy McElroy
90 Min
Product Id: 704377
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
![](/images/products/large/703739.jpg)
Current Concepts and Challenges in Cloud Compliance
Angela Bazigos
90 Min
Product Id: 703739
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
![](/images/products/large/704152.jpg)
CDISC Mapping 1: Specifications and FDA Requirements
Sunil Gupta
90 Min
Product Id: 704152
This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
![](/images/products/large/703482.jpg)
Medical Device Employee Training - Requirements and Implementation Tips
Betty Lane
60 Min
Product Id: 703482
This webinar will review types of training requirements from the FDA and ISO 13485 for medical device employee. It will discuss techniques for monitoring and documenting training effectiveness.
![](/images/products/large/705841.jpg)
Establishing a Medical Device Security Program
Robert Mai
60 Min
Product Id: 705841
In this medical devices security webinar you will learn how to establish a Product Security Program that help your organization to put the right people, processes, and technology in one place to solve the changing landscape of connected medical devices and the risks that are associated with the new environment. It will also highlight the medical device security leading best practices the industry has been implementing to not only meet regulatory requirements but also increasing customer’s needs.
![](/images/products/large/705801.jpg)
EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations
Robert J Russell
90 Min
Product Id: 705801
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.
![](/images/products/large/705916.jpg)
Design for Quality and Compliance
Susanne Manz
120 Min
Product Id: 705916
This 2-hour webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance result. This webinar can help you create a design control process that is a competitive strength for your company.
![](/images/products/large/700830.jpg)
Complaint Handling, MDR's & Recalls
John Chapman
60 Min
Product Id: 700830
This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.
![](/images/products/large/705907.jpg)
Achieving Success and Compliance in the Supply Chain
Danielle DeLucy
60 Min
Product Id: 705907
This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.
![](/images/products/large/705934.jpg)
Responding to a Dose Audit Test Failure
Gerry O Dell
60 Min
Product Id: 705934
This webinar on dose audit test failure for medical device will discuss the various items that should be investigated to determine the root cause, what are the immediate actions that are required and steps to be taken to evaluate product in the field.
![](/images/products/large/704745.jpg)
Data Governance for Computer Systems Regulated by FDA
Carolyn Troiano
60 Min
Product Id: 704745
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
![](/images/products/large/704528.jpg)
Cell Based Assays: Development and Validation
Michael Simonian
60 Min
Product Id: 704528
This training program will focus on how cell cultures are used for in vitro assays. It will include examples of cell based assay systems and list the advantages of cell based assays. The webinar will help attendees understand the uses of in vitro testing with eukaryotic cell based systems, the parameters to be considered in the development and optimization of a cell based assay and the validation of a cell based assay.
![](/images/products/large/705153.jpg)
Human Factors Engineering in New Product Development
Tom Kramer
120 Min
Product Id: 705153
This webinar will define human factors engineering and its role in the success of new product development. The session will use real world examples to demonstrate how human factors engineering makes a significant.