All FDA Regulated Industry
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..
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..
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..
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..
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..
GCP Risk Management and Risk-Based Monitoring
This webinar offers a comprehensive exploration of the critical elements involved in ensuring the ethical conduct, integrity, and success of clinical trials. Participants will delve into the foundational principles of Good Clinical Practice (GCP), gaining a deep understanding of its significance in maintaining the highest standards throughout the clinical trial lifecycle. The training will navigate the comp..
Social Media Communications that Comply with FDA and FTC regulations
In today’s digital-first world, social media has revolutionized how businesses communicate and engage with their audiences. For companies in regulated industries such as pharmaceuticals, medical devices, dietary supplements, and cosmetics, social media platforms like Instagram, Facebook, Twitter, and LinkedIn offer powerful opportunities to connect with consumers, build trust, and promote products. However,..
Computer System Validation (CSV) Boot Camp
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety. We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 2..
FDA Compliance for Regulated Systems using COTS, Cloud, and SaaS Solutions
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.The approach to developing software, performing validation and maintaining a syst..