Information Technology
-
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... -
Using HR Analytics – The KISS (Keep It Simple Silly) Method
This webinar will highlight how employers who has a lot of data about their employees can effectively find out related and un-related data, how to process it for and use as a simulator tool, create performance and engagement analytic... -
Sale!
Using Run and Control Charts to Understand Variation
Quality improvement experts around the globe know that a picture is worth a thousand words. Instead of relying on complicated and confusing data tables, we prefer to make a picture of the data and let the picture do the... -
Validation and Control of Excel® Spreadsheets in Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software and... -
Validation and Control of Excel® Spreadsheets in Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA’s GxP and 21 CFR Part 11 require users of software and... -
Validation and Part 11 Compliance of Computer Systems – 3 Hours Virtual Seminar
This Computer System Validation Training course will explore proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Today, the FDA performs both GxP and Part 11 inspections, the Europeans have released an...
