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Key Considerations in Verification & Validation of Medical Devices
Mercedes Massana
60 Min
Product Id: 701772
This medical device verification and validation training will dissect some of the FDA 483 observations related to design verification and design validation, and provide key information on how they can be prevented.
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Tests for Outliers
Steven Wachs
60 Min
Product Id: 704404
This training program will address when to exclude outlying data points from an analysis. It will illustrate how best to apply sensitivity analysis to determine the impact of removing data. Participants will learn to perform and interpret hypothesis tests for outlier detection.
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Post Market Surveillance for Medical Devices
Daniel O Leary
90 Min
Product Id: 702377
This 90-minute webinar covers all aspects of post market surveillance (PMS) for medical devices. It will direct you to the specific documents for the detailed information you need for an effective post-market surveillance system.
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Three Ways Home Healthcare is Changing the Medical Device Game
Tom Kramer
60 Min
Product Id: 705228
This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.
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FDA vs Health Canada
Rachelle D Souza
60 Min
Product Id: 704862
This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.
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Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)
Mercedes Massana,Tim Stein,John E Lincoln,Edwin L Bills
3.5 hrs
Product Id: 702297
This medical device software development, verification and validation training package of four courses covers wellIEC 62304 requirements and explains risk based approach for validation using validation protocols and GAMP®.
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UDI in the EU – A Preliminary Look
Daniel O Leary
90 Min
Product Id: 704854
Many companies offer their devices in the EU, so must comply with the EU UDI regulations. There are significant differences from the US system. While some details remain, there is sufficient information to allow companies to start planning. This webinar can help you prepare for this major aspect of the new EU regulations.
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Overview of Changes in ISO 13485: 2016
Lena Cordie Bancroft
60 Min
Product Id: 704756
This training program will discuss changes from ISO 13485: 2003 to ISO 13485: 2016. Attendees will learn how to apply additional supplier controls and understand how improvement and corrective action clauses are strengthened.
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How to Design and Implement a Dynamic Control Plan
William Levinson
90 Min
Product Id: 705171
Learn how the FMEA and control plan can be combined to create a dynamic control plan, a living document that helps to drive continual improvement.
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How Create a Value-added cGMP/ISO 13485 Internal/Supplier Auditing System
Betty Lane
60 Min
Product Id: 705165
This webinar will cover creating of a value-added an internal and supplier auditing program for compliance to FDA and ISO 13485 internal auditing requirements. It will include how to set up and manage the auditing system, as well as how to conduct audits, and document the results and any nonconformities. It will discuss the value of a good auditing program.
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Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012
Daniel O Leary
90 Min
Product Id: 703752
Medical device manufacturers need systems to implement regulatory requirements (meeting customer requirements and handling regulatory complaints) as well as a business processes to determine customer satisfaction. While the three systems are related, each serves a different purpose. You will learn how to implement a customer satisfaction process to complete theses three important aspects.
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What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries
Rossano V Gerald
60 Min
Product Id: 705186
When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.
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GMP Training Practices to ensure Regulatory Compliance
Henry Urbach
90 Min
Product Id: 705077
By attending this webinar, you will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. In this webinar your instructor will share with you what he has learned over the past decade of developing and delivering effective GMP training programs as well as from his 25 plus years of working in the Life Science industries.
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MDR Program conforming to New FDA Guidance
Edwin Waldbusser
60 Min
Product Id: 705149
FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion.
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Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Joy McElroy
90 Min
Product Id: 704306
This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.
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Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom
Jim Polarine
90 Min
Product Id: 705078
This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.
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Linear Regression Analysis for Medical Device Manufacturing
Daniel O Leary
90 Min
Product Id: 705108
Analyzing processes to understand their operation and implementing improvement is a necessary element in any quality system, but is especially important in medical devices. One of the more important tools is linear regression. Using Excel, you can get the information you need for process improvement.
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Introduction to FDA and EU Medical Device Submission
Charles H Paul
60 Min
Product Id: 705065
This webinar will overview each critical aspect of the FDA submissions process to include 510(k) and PMA) and contrast those key steps to those of the EU Medical Device Directives Submissions process.
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Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
Daniel O Leary
90 Min
Product Id: 701388
This webinar provides the tools needed to understand and implement acceptance sampling. It explains the basis for sampling plans, the binomial distribution, and uses it to understand the sampling plan’s performance using the operating characteristic (OC) curve.
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Reimbursement Requirements for Designing Innovative Devices
Tom Kramer
60 Min
Product Id: 704625
This training program will highlight key metrics needed to convince reimbursement panels of design compliance and discuss how best to implement practices in your development process that ensure acceptance by reimbursement groups.