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Risk Management Activities during Design Input
Edwin L Bills
60 Min
Product Id: 700526
Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation. Risk Management Activities can lead to reduced cost and reduced time to market when conducted during the Design Input phase of product development. Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation.
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Designing Viral Clearance Studies for Biopharmaceuticals
Kathryn Martin Remington
60 Min
Product Id: 700220
This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.
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Design for Six Sigma in Medical Devices: Integration with the FDA Quality Systems Regulations
Vinny Sastri
60 Min
Product Id: 700139
This Six sigma training in Medical device will demonstrate the value of using DFSS principles in developing such devices by identifying critical design, production and distribution parameters that affect the performance of the finished device. Design for Six Sigma (DFSS) can be used to design, manufacture and sell high quality, defect-free, safe, effective devices that meet the intended use while also generating healthy profit margins for the company.
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Auditing a Compliance and Ethics Program Evaluating the Design and Operating Effectiveness
Dan Swanson
60 Min
Product Id: 700238
This Auditing training will show you how to audit your compliance and ethics program and how to Evaluate the Design and Operating Effectiveness. Organizations are exposed to governance, compliance and ethical risks daily. Coupled with the current economic, regulatory and social climate, these risks have propelled corporate governance, compliance management and integrity to a top business priority
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Designing in Quality via Statistical Process Control
Vinny Sastri
60 Min
Product Id: 700411
This statistical process control training will provide an overview of statistical process control (SPC) describe various types of control charts and how they can be used for trend analysis, defect reduction, product capability assessment. Quality, safety and efficacy must be designed into a product. Quality cannot be inspected or tested in the finished product.
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Making FMEA a More Efficient and Powerful Patient Safety Improvement Tool
Patrice Spath
60 Min
Product Id: 700396
This FMEA (Failure mode and effects analysis) training will cover the Joint Commission requirements for conducting a proactive risk assessment using the FMEA methodology.
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Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH
Alfredo J Quattrone
60 Min
Product Id: 700442
This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.
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Validation Challenges for Bioassays
Dr. Wise Blackman
60 Min
Product Id: 700232
This Validation training will provide guidance in overcoming inherent variability in bioassays. Performing good optimization studies will lead to a well-defined method for future qualification and validation of the assay
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Training Requirements and Practices to Assure QSR and ISO Compliance
Jeff Kasoff
60 Min
Product Id: 700316
This Medical device training will instruct on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training. To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.
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Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations
Susan C Reilly
60 Min
Product Id: 700134
This Management control training will provide the principles and practices needed to effectively develop and implement the Management Controls to ensure an effective Quality Management System and to comply with the FDA QS Regulation.
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Complaint Handling and Management: From Receipt to Trending
Jeff Kasoff
60 Min
Product Id: 700319
This Complaint Handling training will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback.
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CAPA Essentials - core principles and practices needed to implement an effective and efficient CAPA process
Susan C Reilly
60 Min
Product Id: 700299
This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process
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Medical IT Device Security: Why Medical Device Manufacturers Must Take the Lead and Drive Regulatory Compliance
Lori Kahler
60 Min
Product Id: 700351
In this Medical device training will provide valuable assistance to regulated companies on how to drive regulatory compliance for IT based medical devices.
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Parallel trade of medicinal products in the EU - Latest case law and Commission decisions
Jose Mora,Hector Armengod
60 Min
Product Id: 700198
This Medical device training will talk about recent developments in the European Commission’s approach towards the parallel distribution of medicines. In the past the European Commission has taken a strong stance against restrictions imposed by pharmaceutical companies on wholesalers and distributors of medicines, preventing them from parallel importing the contract products within the European Union ("EU").
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An Overview of Risk Management and Risk Analysis Techniques
Robert DiNitto
60 Min
Product Id: 700206
In this Risk management training we will review the concept of Risk Management, its various elements, what is required, and its benefits. How are you meeting the FDA and ISO risk management requirements? Hazard Analysis? FMECA? dFMEA/pFMEA? The concept of Risk Management and the difference between risk analysis, evaluation, assessment, and management.
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Internal Auditing Essentials for Medical Device Manufacturers to comply with FDA QSR and ISO13485
Susan C Reilly
60 Min
Product Id: 700135
The principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485. This medical Device training will provide the principles and practices needed to effectively develop, implement, and perform internal quality management system audits that comply with the requirements of the FDA QS Regulation and ISO 13485.
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Effectively application of FMEA as a Risk Management Tool and meet ISO 13485:2003 Risk Management (ISO 14971) Requirements
Angelo Scangas
60 Min
Product Id: 700329
In this Medical device training understand the expectations of FDA and the EU in applying risk analysis to medical devices. Risk Management is required by ISO 13485 and risk analysis by the FDA’s Quality System Regulations (QSR) and by of the EU medical device regulations. Using practical examples, this course look at the regulatory and reporting requirements of EN ISO 14971, "Medical devices - application of risk management to medical devices".
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The Revision of the Medical Devices Directive 93/42/EEC, Background, Proposal and What It Means
Trevor Lewis
60 Min
Product Id: 700148
Key insights to the background of the revision for medical device manufacturers with products in Europe. The Medical Devices Directive 93/42/EEC (MDD) is the key European Directive for regulatory compliance and placing of a CE mark on a medical device.
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Internal Auditing of Risk Management: Emphasis on effectiveness and compliance to QSR, ISO 13485 and ISO 14971
Phil Smart
60 Min
Product Id: 700272
This Internal audit training will guide on how to set up an ISO 14971 audit program with specific auditor guidelines.
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Validation of Computerized Analytical Systems
Dr. Ludwig Huber
60 Min
Product Id: 700212
This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.