252 past events found
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Ensuring Data Integrity in Method Validations
Overview:The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity. Why should you Attend:The guidance changes how FDA regulated methods will be developed, validated and used. Additionally, how to ensure Data Integrity will be discussed. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters,...
February 28, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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Validation of FDA-Regulated Computer Systems
Overview:You'll learn about the various computer system validation deliverables and how to document them through the entire process. You will learn about what must be done to ensure the system remains in a validated state. Why should you Attend:This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA reg...
February 2, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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Software Validation for the New FDA Ins...
Overview:This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing. Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FDA approval. There are additional requirements,analyses and tests that FDA feels are necessary to prevent user injuries. Areas Covered in the Session:Software Validation more than TestingRequireme...
January 30, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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Excel - Benefits and Hazards in Office 365
Overview: In this valuable presentation, Excel expert David Ringstrom, CPA, explains how the Office 365 version of Excel 2016 differs from previous versions and perpetual licensed versions of Excel 2016. Historically, each major version of Excel was identical for all users, but that's no longer the case. Why should you Attend:Apply pivot table-specific options in the Office 365 version of Excel 2016 to minimize repetitive workLearn keyboard sh...
January 19, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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How To Facilitate a Closed-Loop Problem...
Overview:Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations. Why should you Attend: Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are growing among regulatory agencies world-wide. Areas Covered in the Session:Regulatory "Hot Buttons"The 4...
January 17, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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Which Data and Systems are Subject to Part 11
Overview: This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach. Areas Covered in the Session:Which data and systems are subject to Part 11What Part 11 means to you, not just what it says in the regulationAvoid 483 and...
January 16, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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The Value of a Human Factors Program
Overview: This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program. Why should you Attend: This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were...
January 12, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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Clinical Data Systems Regulated by FDA
Overview: 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. Why should you Attend: You should attend this webinar if you are responsible for establishing or maintaining a TMF, or providing quality assurance for data included in the file...
January 12, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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Ensuring Data Integrity and Safety in C...
Overview: Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11. Why should you Attend: The increasing use of computers and increasing complexity, all persons who have any data input requirements to know the set-up and function of the systems they are using. Forewarned is forearmed. Areas Covered in the Session:The CFR defini...
January 9, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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Act for Transportation and Logistics Pr...
Overview:The FSMA is paradigm shift that moves the focus from food inspections to preventative measures and process compliance. Why should you Attend:Specific provisions of the FSMA that impacts transportation and 3rd party logistics providersSanitary transportation best practicesTo develop a food safety plan that identifies potential risks, preventative controls and ongoing monitoringNew rules that govern food importers and exporters Areas Co...
January 8, 2018
Organizer: NetZealous - Compliance4All
Location: Webcast
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