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Design Controls for Medical Devices under a Quality Management System
Design controls are a discipline that everyone in the medical device industry have to come to grips with. It encompasses systems engineering, risk management, mechanical/electrical/software design, usability engineering, and testing (verification and validation). The documentation of these activities is critical to both develop a good product but also to ensure a smooth regulatory clearance.Areas CoveredBac..
Data Privacy: California Privacy Rights Act (CPRA), Health Information Portability and Accountability Act (HIPAA), and General Data Protection Regulation (GDPR)
During this webinar, in addition to learning about the California privacy rules, we will discuss the Health Information Portability and Accountability Act (HIPAA) in the US and the General Data Protection Regulation (GDPR) that is in effect to protect citizens’ personal data when they reside in the European Union (EU). We will compare and contrast these with the CPRA, providing specific requirements and how..
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
Establishing appropriate Quality Assurance metrics is important for several reasons. Metrics not only measure the health of your quality system, they have the ability to change behavior, drive quality culture, and improve both individual and company performance. This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize t..
Modernizing Lab Notebooks
In the realm of scientific research, the documentation of experiments and observations is not only a crucial aspect but often a regulatory requirement. Traditionally, this documentation has been done through physical lab notebooks, serving as a tangible repository of scientific endeavors. However, as technology advances, the landscape of lab documentation is evolving rapidly. In a recent seminar titled "Mod..
The Transfer Of Validated Methods
Even a detailed and well-written standard operating procedure for a method cannot ensure that 2 laboratories running on aliquots of the same will get statistically equivalent results. Using different instrumentation, standards, reagents, solvents, and other chemicals, data systems, sample storage and handling procedures, and other variables are common and can lead to different results. Making each operation..
LIMS System Validation and Compliance Issues For Regulated Labs
The webinar covers the validation of the Laboratory Information Management System (LIMS) which can be essential for regulatory compliance. The webinar will cover over a dozen key steps in achieving compliance. The process includes defining operational requirements in a User Requirements Specification (URS), assessing supplier quality systems, and developing Functional Specifications (FS). Risk assessment gu..
COTS, Cloud, and SaaS Systems and FDA Validation Compliance
“How can we perform an Installation Qualification (IQ) when the server is completely under the control of a vendor?”“How do we know the vendor will be able to manage security, backups, disaster recovery, and other aspects required to ensure data is collected and maintained with integrity?”“What about change control?”“How will we handle compliance with 21 CFR Part 11, FDA’s guidance for electronic records an..
Cybersecurity challenges in medical device technology
The landscape of medical device technology is rapidly evolving, with an increasing reliance on interconnected and digitized systems within the healthcare industry. This shift, while bringing about numerous benefits in patient care and data management, also introduces a host of cybersecurity challenges. The complexity of modern medical devices, coupled with the integration of wireless communication and embed..
Design Planning, Design History Files and Design Reviews
Design planning, use and maintenance of design history files and periodic design reviews are crucial and integral parts of design control. All development projects in the medical device space will start with design planning. Without robust planning, it is not possible to keep track of everything that is needed during the development of a medical device. The planning stage and process will lay out and define..
Medical Device Standards – Deeper Diver
This event will help you to learn how the standards are developed, who engages, and key steps in the process. You will hear about the Governance Structure of standards-developing organizations including the committee. You will learn about the important roles and responsibilities of standards development. Areas Covered Steps and Parties engaged in Standards development New Work Item P..
Why Using Manual Lab Data Management And Excel Is Bad For Your Organization?
This webinar will uncover the reasons why manual paper or spread sheets can impede your Lab’s operational efficiency and cost you more money in the long term.Discover how to improve data handling and improve its integrity to allow better quality control with full audit capability.Gain insights into how a LIMS can overcome the shortcomings of manual/spreadsheet systems, by managing your data much more effect..
Outsourcing Software development for Medical Devices
Many companies do not want to invest in building a software team and outsource the software development efforts for their medical device. Selecting the right development company can make or break your project. Even after selecting your partner, you still need to manage them. We’ll give a high-level overview of the software development process and what you need to know in order to ensure your software ..
Clinical Trial Systems: Trial Master File (TMF) and eTMF, & FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
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). All of the data and documents supporting the planning, conduct and e..
Design Verification and Validation For Medical Devices and Combination Products
Verification and validation of design inputs is a critical step in the development of medical devices. It is the objective evidence that the developer developed what they set out to develop and the final product meets its design goals and needs of the end user. Without proper verification/validation of inputs, it is not possible to prove to regulatory agencies that you have a product which is safe and effec..
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..