Information Technology
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Project Management for Non-Project Managers – 3 Hours Virtual Seminar
It is not possible to present a complete treatment of project management in the span of 3-hours. It is however, possible to focus in on those most important aspects of project management that are critical to the success of... -
Risk Assessment in CSV
Areas Covered in the Session : CSV Components and Deliverables URS, FS & DS TRM, SR, IRA and FRA Risk Based Approach for CSV Understanding Risk Assessment Risk-Based Validation approach to lower costs Regulatory Expectations Examples and Good Practices... -
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Risk-Based Computerized Systems Validation – The Practical Approach
Risk-Based Approach to Computerized Systems Validation (CSV) has been a challenging concept to implement since the topic was introduced through GAMP5 in 2008. This vital fundamental activity is considered by Health Authorities to be the only acceptable way of... -
SDLC Modernization Continuous Quality in an FDA-Regulated Environment and Journey to Paperless SDLC/CSV
Areas Covered in the Session : Learn how to identify “GxP” Systems Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements Learn about the System Development Life Cycle (SDLC) approach to validation and how... -
Software As a Medical Device (SaMD) New IVDR Document Requirements
This course is essential for IVD Medical Device companies interested in ensuring their software enabled medical Devices or Software as an IVD Medical Device is compliant to the new Software requirements in the IVDR 2022 regulations avoiding revenue interruptions... -
Statistical Process Control (SPC) and Control Charts – In Accordance with Latest FDA Expectations
Statistical process control (SPC) is a method of quality control which employs statistical methods to monitor and control a process. It is one of the fifteen subpart requirements of the US FDA’s QS Regulation, 21 CFR 82, the Medical... -
Step-by-Step approach for Setting up FDA Audit Ready Quality Management System (QMS) – Case Studies based training
This webinar will discuss the key features involved in setting up / building your Quality Management System (QMS) so you are ready for FDA and other supplier/ISO certification related audits. Manufacturers of FDA regulated products such as medical devices,... -
System Development Life Cycle (SDLC) Methodology and FDA-Regulated Systems
This webinar will discuss the System Development Life Cycle (SDLC) Methodology and the importance of following this approach when validating computer systems subject to FDA regulations. Upon completion of this session, attendees will have an understanding of how to... -
The Excel VLOOKUP Crash Course
Do you want to improve the accuracy and integrity of your Excel workbooks? Do you want to save a ton of time and minimise data entry errors? VLOOKUP, HLOOKUP, INDEX and MATCH are some of the most well-known (and... -
The Requirements and Responsibilities of a HIPAA Security / Privacy Officer
Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from... -
The Requirements and Responsibilities of a HIPAA Security / Privacy Officer
Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from... -
The Requirements and Responsibilities of a HIPAA Security / Privacy Officer
Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from... -
Top Data Breaches for 2018 – Learn from top healthcare industries
Data breaches in healthcare settings are a very real and very prevalent problem. But did you know that more than half involve insiders? And that the most affected assets are not medical devices but databases and paper documents? Protect... -
Trial Master File (TMF) – Clinical Trial Systems and FDA Expectations
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... -
Understand the HIPAA Security & Privacy Rules
Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited... -
Understand the HIPAA Security & Privacy Rules
Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited...
