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BEST-SELLER : Most Valuable Non-Technical Skills for Scientists
Soft skills, those non-technical and non-scientific understandings that help a person effectively interact and communicate, are based on knowledge that is completely separated from what work goes on in the laboratory. But they are often key to a project’s success or failure. If the end user of the data does not understand the data or the caveats that are part of it (uncertainty, accuracy, etc.) then the exp..
BEST-SELLER : Non-Product Computer Software Validation
Non-product software validation is one of the most misunderstood processes in the medical device industry. In reality, software validation should be something that companies embrace! The whole intent is to ensure that the software does what it’s supposed to do, is robust enough to handle whatever its users do, and can be maintained for the life of the software. So why all the consternation? Typically, it’s ..
Is a Certificate of Analysis (CoA) Enough
The topic of the role of Certificates of Analysis (CoAs) in quality management and supplementary practices encompasses several key areas:Role of CoAs in Quality ManagementVerification of Product Quality: CoAs provide detailed information about the quality and purity of products, ensuring that they meet specified standardsTraceability: They include batch numbers and testing dates, which help in tracing any i..
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 understan..
Best Practices for a Compliant, Lean Supplier Management Program
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that y..
The Key Elements of Being “Recall-Ready”: FDA’s Current Recommendations Related to Timely Initiation of and Responses to Recalls
Recalls are one of the most challenging events a regulated organization can face, yet they are vital for protecting public health and maintaining compliance with FDA regulations. Whether you are a manufacturer, distributor, or contract manufacturing organization (CMO), understanding how to navigate the recall process is essential for safeguarding your reputation and meeting regulatory expectations. This web..
CAPA Best Practices and Pitfalls to Avoid
For at least the last 20 years, the CAPA systems have been the leading cause of audit findings (nonconformities) and FDA inspection findings (483s). And there’s no sign that things are getting any better.CAPA and CAPA-related findings include lack of documentation / documented evidence, lack of timeliness, root cause(s) not being identified, failure to show effectiveness of actions, and on and on. Bas..
Pharma and Biopharma Application, Market, and Segment Assessments for Ultrafiltration (UF)
Ultrafiltration (UF) is the highest barrier to contamination of the water after generation. UF low molecular weight rejection at 5,000 – 6,000 daltons and small pore size offers the best mechanical barrier to endotoxin carry over. This presentation describes all the filtration issues from larger micron sized used in microfilters to the ultralow nanometer sized filtration. Filtration in the pharmaceuti..
Product Disposition Process from a GxP Point
IP disposition and release are essential aspects of clinical trial conduct. These processes ensure compliance with Good Practice (GxP) guidelines and regulatory requirements, maintaining the integrity, safety, and quality of clinical trial data. The IP release process involves several crucial steps to ensure the investigational product (IP) meets all necessary quality, regulatory, and protocol-specific requ..
Biosimilars - are they right for you
The first biosimilar (Omnitrope = somatropin) was registered by the EMA (European Medicines Agency) in 2006. By contrast, the FDA was not able to register any US biosimilars until 2015, when Zarxio (filgrastim-sndz) became the first biosimilar product to receive US approval.Since then, the FDA has been playing “catch-up” so that by mid-2024, the number of US-approved biosimilars was 60 compared to 106..
Business Process Mapping: Streamlining Management of Data/Records for a Clinical Trial from a Variety of Stakeholders And Systems
The plethora of data, both structured database records and unstructured data, such as documents, PDFs, Excel spreadsheets, and other key artifacts, makes the assembly of a clinical TMF/eTMF a daunting effort. There are many stakeholders sending in key data about the trial to the sponsor. The many artifacts come from a variety of systems based on differing technologies and platforms and using differing commu..
ISO 13485 2015 utilizing Principles of Lean Documents and Lean Configuration
All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2015 revision changes. They will have the additional responsibility to ensure that each and ev..
FDA Recommendations for Artificial Intelligence or Machine Learning - Enabled Device Software Functions
The US FDA has determined that a predetermined change control plan or PCCP be included in the marketing submission for a medical device software that incorporates AI or machine learning models and algorithms. Manufacturers of AI or machine learning software devices are to anticipate or foresee potential modifications post FDA approval and these could be based on perceived risks foreseen or effectiveness imp..
Role of Cognitive Load in Medical Device Design and Human Error
The webinar delves into the critical nexus between healthcare technology and user performance. The 90-minute session begins with an exploration of cognitive load, dissecting its intrinsic, extraneous, and germane components. By unraveling the complexities of cognitive load, participants gain a profound understanding of how the mental burden associated with interacting with medical devices can impact decisio..
Holding Vendors Accountable through Robust Contracts and Service Level Agreements (SLA) for Products and Services Used in FDA-Regulated Operations
In this webinar, the attendees will learn about the many best practices that will lead to a better and sounder contract and SLA. It does not require a lot of effort but must be done with diligence.Computer systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product or a raw material or packaging component used in conjunction with the product during the manuf..