Medical Devices

$179.00
Equipment Qualification and Validation of Processes

 March 31 2023
 01 : 00 PM EST    
 90 Minutes
Equipment Qualification and Validation of Processes

The course will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. This course will provide discussion on European and FDA regulations as well as global harmonization and expectations. The course will also cover specific aspects of equipment qualification and process validation, such as protocol writing, methodology and performance, report writ..

$199.00
Fundamentals of Design and Development for Medical Devices

 April 18 2023
 01 : 00 PM EST    
 60 Minutes
Fundamentals of Design and Development for Medical Devices

This webinar shall discuss the Design and Development different phases for medical devices as depicted within the Medical Device organization.Since the design and development phase is the cornerstone of the product’s quality and organization’s ability to introduce its products easily to the markets.Proper knowledge of the regulatory and quality requirements of design and development will ensure a robust des..

$199.00
Computer Software Assurance (CSA) – FDA’s Draft Guidance for Validation of Regulated Computer Systems

 May 15 2023
 01 : 00 PM EST    
 90 Minutes
Computer Software Assurance (CSA) – FDA’s Draft Guidance for Validation of Regulated Computer Systems

Advancements in technology have forced organizations to rethink their business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.The approach to developing software, performing validation and maintaining ..

$199.00
Bulletproof Corrective and Preventive Actions (CAPA)

 May 18 2023
 01 : 00 PM EST    
 60 Minutes
Bulletproof Corrective and Preventive Actions (CAPA)

This webinar shall introduce: When CAPA is requiredHow to manage CAPA The best approach to document How to manage a CAPACAPA’s pitfallsAreas Covered Sources of CAPARoot Cause Analysis methods Proper documentation of CAPAFollow-up for effectivenessCourse Level - BasicWho Should AttendQA Managers, QA Engineers, R&D Engineers, R&D Managers, Production Engineers, Production ManagersWhy Should You Attend..

$199.00
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

 June 13 2023
 01 : 00 PM EST    
 90 Minutes
FDA’s Technology Modernization Action Plan (TMAP) and Impact on Regulated Computer Systems and Data

This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.We will also discuss FDA’s more recent push to Software Quality Assurance (SQA) and away from traditional Comp..

$199.00
Trends in FDA Compliance and Enforcement for Regulated Systems

 July 17 2023
 01 : 00 PM EST    
 90 Minutes
Trends in FDA Compliance and Enforcement for Regulated Systems

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC and GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the ..

$199.00
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities

 September 11 2023
 01 : 00 PM EST    
 90 Minutes
FDA Guidance on the Use of Social Media: Know Your Responsibilities and Potential Liabilities

This webinar will help you understand in detail the application of FDA’s guidance on the use of social media in presenting and promoting information about drug products and medical devices subject to FDA regulation. This is critical in order to develop the appropriate strategy, policies and procedures to ensure compliance.Areas CoveredPros and cons of using social media venuesCompliant use of Social Media i..

$199.00
Medical Device Cybersecurity and FDA Compliance

 October 16 2023
 01 : 00 PM EST    
 90 Minutes
Medical Device Cybersecurity and FDA Compliance

This session will provide some insight into current trends in cybersecurity threats to medical devices and how to follow industry best practices to prevent and/or mitigate these threats.Cybersecurity is a serious concern for medical device safety and effectiveness. Without protection, software running on a medical device could cause severe injury or death to a patient.There are many forms of cybersecurity a..

$200.00
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

 Recorded Webinar
 90 Minutes
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Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software

Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..

$200.00
EU Medical Devices Regulation: The Practice

 Recorded Webinar
 90 Minutes
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EU Medical Devices Regulation: The Practice

The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm. During this class, participants will be introduced to the new requirements in the Medical Device Regulation (MDR), inc..

$200.00
Implementing a Change Control Quality System Successfully

 Recorded Webinar
 60 Minutes
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Implementing a Change Control Quality System Successfully

This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..

$179.00
Cost of Quality for Medical Devices

 March 14 2023
 01 : 00 PM EST    
 60 Minutes
Cost of Quality for Medical Devices

How can one assess the effectiveness of a Quality Management System?The best way to do that is by using the ultimate transfer unit: MONEY!The purpose of a firm is to make Money, the purpose of a QMS is to enable the firm to produce, and therefore – generate money with minimum losses that are reflected by failures.The principles are known, but is it done?This lecture will give the listener the basic know-how..

$200.00
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

 Recorded Webinar
 90 Minutes
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2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance

This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..

$200.00
21 CFR Part11 Compliance

 Recorded Webinar
 60 Minutes
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21 CFR Part11 Compliance

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants t..

$200.00
5S for Operators

 Recorded Webinar
 90 Minutes
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5S for Operators

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..

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