Medical Devices
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Cyber Security Planning for Medical Devices
How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures can... -
Cybersecurity – FDA Requirements Masterclass
Cybersecurity is the art of protecting networks, devices, and data from unauthorised access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information. Cybersecurity is the preventing the theft / modification of e-records by... -
Data Governance for Computer Systems Regulated by FDA
Organizations governed by FDA must adhere to strict requirements relative to data being captured, analyzed, reported or stored on computer systems. As such, organizations must be able to manage the data effectively, realize value from it, minimize the cost,... -
Data Integrity – In compliance with CSA, 21 CFR Part 11, SaaS/Cloud and EU GDPR
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement... -
Data Integrity and Privacy – compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection... -
Data Integrity by Design, Pharma 4.0 and Overcoming DI issues in the Cloud
Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation, operation, and retirement of computerized systems supporting that business process. It promotes the application... -
Data Integrity for the Laboratory and Beyond
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid... -
Data Integrity In Quality Computer Systems, Risk and Strategies
This webinar will present: What IT Compliance and QA professionals as well as Business Users with responsibilities for system ownership, must do to protect the integrity of their data and systems. How to assess possible risks to your data... -
Dealing with Out of Specification (OOS) Test Results
Dealing with OOS presents a major challenge to several laboratories. Successfully interpreting regulatory expectations in this area and practically dealing with OOS results from USP, non USP chemical, microbiological and physical test measurements will be described in this valuable... -
Deconstructing the EU MDR with Principles of Lean Documents and Lean Configuration
The EU MDR is a comprehensive and complex regulation that combines all aspects of placing certain types of medical devices on the EU market into one regulation. It addresses the obligations of economic operators in this role, and provides... -
Demystifying Design Control: Design History File (DHF), Device History Record (DHR), and Device Master Record (DMR)
Each manufacturer of any class III or class II device, and the some class I devices shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. This... -
Demystifying Design Inputs – Design Outputs, Traceability Matrix
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls... -
Demystifying Design Inputs – Design Outputs, Traceability Matrix
Design controls involve the translation of user requirements (aka Voice of the Customer) into specific technical requirements as design inputs. These design inputs then form the basis of the design specification, which becomes the design output. Since design controls... -
Design History File (DHF) Remediation using Principles of Lean Documents and Lean Configuration
Does your DHF remediation process resemble the very mess that it is trying to resolve? The Design History File (DHF) is the objective evidence that a medical device was designed per design control guidance and applicable regulations and standards.... -
Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each
After the Final Rule of the Quality System Regulation became effective, a moratorium on enforcement was placed for one year, until the ISO regulations went into effect for design control for medical devices. Since the design control regulations became... -
Design History File (DHF), Device History Record (DHR), Device Master Record (DMR) and Impact of Change Controls on Each
After the Final Rule of the Quality System Regulation became effective, a moratorium on enforcement was placed for one year, until the ISO regulations went into effect for design control for medical devices. Since the design control regulations became...