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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..
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 ..
Mastering Quality Assurance (QA) and Good Manufacturing Practice (GMP) in Drug Production
This training is a multifaceted and indispensable undertaking in the pharmaceutical industry. This webinar provides a comprehensive exploration of the principles, regulations, and practical applications essential for ensuring the consistent quality, safety, and efficacy of pharmaceutical products. Participants will gain insights into the foundational elements of QA, understanding how to design and implement..
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 evalua..
The Role of LIMS in Supporting ISO Accreditations
Discover how to deal with the complexities of ISO accreditations.Gain insights into how a LIMS can help support ISO accreditations by managing your data much more effectively.Learn how a LIMS can improve your daily lab operations, saving both time and money. Typical payback time on using a LIMS is less than 2 years, saving your company around 85% of the LIMS cost each year afterwards whilst enjoying i..
Applying Risk-based Approaches to Processes Under the Quality Management System
Just about every process in the QMS can be driven through risk-based thinking. Creating a simple and effective plan is key to a successful application. This discussion will outline specific proven approaches to specific processes, ensuring both a rigorous approach and one that is acceptable to auditors/inspectors.Areas Covered The “big” ones: purchasing, training, computer system validationOthers: Aud..
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..
What is IMDRF and What is The Value to Industry to Engage?
This event will help you to learnabout IMDRF. The event will allow you to understand the history and the associated stakeholders including the countries that are actively engaged in the development. You will also learn about where harmonization has been achieved as well as where there continues to be challenges like in device classification, risk and practice of medicine. The event will help OEMs understand..
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..