Clinical Trial and Clinical Research

$179.00
Robust CAPA Process for Medical Devices

 December 07 2022
 01 : 00 PM EST    
 60 Minutes
Robust CAPA Process for Medical Devices

Mr. Yuval Shapiro shall present the requirements for Corrective and Preventive actions as required by medical devices standards (ISO13485, etc.) and the common practice.The difference between Correction, Corrective Action and Preventive Action will be discussed.Mr. Shapiro shall present common sources for CAPA, tools for root-cause-analysis, e.g. – 5 Why, Cause and Effect Diagram, Pareto Charts, etc.Also, w..

$179.00
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

 December 07 2022
 01 : 00 PM EST    
 60 Minutes
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

Compliance under GLP can be difficult. The setting up of a system to monitor the performance of methods and instruments can lessen this. Statistical Process Control (SPC) uses control charts and statistical guidelines to monitor a wide variety of things in the compliant laboratory. These generate a proactive system to assess problems early on and quickly to be handled by adjustments rather than the strict s..

$179.00
Best Practices for Auditing of Vendor of Computer Systems Regulated by FDA

 December 08 2022
 01 : 00 PM EST    
 90 Minutes
Best Practices for Auditing of Vendor of Computer Systems Regulated by FDA

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health, organ donation, and tobacco. Functions that are applicable include research and development, clinical sample manufacturing, packaging, labeling and distribution, clinical testing and management, adverse events management, and post-marketing surveillance. You should..

$179.00
Environmental Monitoring Investigations

 December 08 2022
 02 : 00 PM EST    
 60 Minutes
Environmental Monitoring Investigations

This seminar will provide an overview of environmental monitoring investigations and tools to complete an investigation. Environmental monitoring is the method by which clean rooms are known to maintain a certain level of cleanliness. The methods by which clean rooms are monitored are through viable and non-viable testing. Through this testing, a room may demonstrate that it is out of control. This seminar ..

$179.00
Risk Based Design Control - The New Paradigm for Medical Device Design

 December 20 2022
 01 : 00 PM EST    
 60 Minutes
Risk Based Design Control - The New Paradigm for Medical Device Design

Design Control is essentially a quality assurance program for the Research and Development department. The VP or Director of research and development owns the design control effort. Over the years many companies have included the design control requirements into their project plans and build the Design History File as part of the development process. Nothing has changed in these basics, but FDA’s and ISO’s ..

$179.00
Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF) and FDA Compliance

 January 25 2023
 01 : 00 PM EST    
 90 Minutes
Clinical Trial Master File (TMF) and Electronic Trial Master File (eTMF) and FDA Compliance

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF).The TMF includes all of the documentation that a sponsor must record to demonstra..

$179.00
EU Medical Devices Regulation: The Practice

 January 25 2023
 01 : 00 PM EST    
 90 Minutes
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), incl..

$179.00
Risk Management - Implementing ISO14971: 2019

 Feb 07 2023
 01 : 00 PM EST    
 60 Minutes
Risk Management - Implementing ISO14971: 2019

Mr. Shapiro shall present the basic principles and practices of Risk Management and Risk Analysis.The risk-based approach has become a key element of quality management and as a fundamental process in the design and development of medical devices product.This process has been streamlined within ISO14971 standard and has become the best practice to show application of risk-based approach implementation in th..

$179.00
Best Practices in Preparation for an FDA Computer System Audit

 February 15 2023
 01 : 00 PM EST    
 90 Minutes
Best Practices in Preparation for an FDA Computer System Audit

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it ..

$179.00
Computer Validation: Methodologies and Approaches for Greater Innovation and FDA Compliance

 April 19 2023
 01 : 00 PM EST    
 90 Minutes
Computer Validation: Methodologies and Approaches for Greater Innovation and FDA Compliance

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 syst..

$179.00
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 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 syst..

$179.00
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..

$179.00
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 ..

$179.00
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

 August 21 2023
 01 : 00 PM EST    
 90 Minutes
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.Areas CoveredCompu..

$179.00
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..

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