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Clinical Sample Analysis: Considerations for the Bioanalytical Lab
Reviews the history of the GCPs from Tuskegee to Nuremberg, Helsinki to the current 21 CFR and other protections, demonstrating the evolution of the regulation's current status. Particular focus will be on constraints, including requirements for informed consent and the disposition of samples. Several illustrations of recent violations will be provided, along with the consequences. Areas CoveredEvolution of..
5S for Operators and Human Error Reduction
Human error is the primary cause of quality and production losses in many industries. Although human error is unlikely to be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce human error is the “5S Method.” This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler, and organized, helping yo..
Computer Software Validation with Focus on FDA Regulations Including 21CFR Part 11
Computer Systems Validation (CSV) is crucial in ensuring compliance, reliability, and security in an FDA-regulated environment, but they differ in focus and execution.Objective: Understanding the distinctions within Computer Systems Validation (CSV) in FDA-regulated settings.Importance: Highlighting the roles in ensuring regulatory compliance and software reliability.Definition: Explain CSV as the process o..
Decoding Drug Data: Understanding Clinical Biostatistics in Pharmacy Practice
Clinical biostatistics is the backbone of interpreting drug studies and delivering evidence-based care in pharmacy practice. Pharmacists and healthcare providers are constantly exposed to clinical trial data—from journal articles and guideline updates to drug monographs and formulary reviews. Yet for many, the statistical components remain a source of confusion or hesitation. Without a firm grasp of key val..
Digital Phenotypes, Digital Twins, and N of 1 Data in the Design of Personalized Measurement-based Clinical Care
The technology currently available for quantifying various biometric, behavioral, emotional, cognitive, and psychological aspects of daily life has become increasingly diverse, accurate, and accessible, with ongoing and continuous improvements. These burgeoning technologies can and will profoundly alter the way lifestyle, health, wellness, and chronic diseases are managed in the future. For those pursuing t..
Stability Testing of Pharmaceutical Products from Regulatory Perspective
This webinar gives a fundamental knowledge of stability testing requirements for establishing storage conditions and expiration of pharmaceutical products.Stability data forms an important element of pharmaceutical regulatory submissions. This webinar will provide participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements. Also, they will be able..
Rapid Microbial Monitoring: Regulatory and Application Strategies for Pharmaceutical Water Systems
Rapid Microbial Monitoring is the newest application for real-time to near real-time assessment of microbial in process or in process steps. The elimination of long incubation times with immediate data can increase dramatically the throughput generating 40-60% more revenue with no change in infrastructure or CAPEX. This technology can pave a fabulous net gain in profits, throughput, revenue, and production ..
Human Error and Management Systems: Designing Errors Out
If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of the quality control unit.” and it states that “(a) There shall be a quality control uni..
Risk Based Design Control - The New Paradigm for Medical Device Design
If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together awkwardly, this webinar will give you a different perspective and a very different approach that you can use.If your design and manufacturing resources spend too much time on documentation and no..
What the FDA 483 Really Means — And How to Respond Like a Pro
An FDA Form 483 isn’t just a list of observations — it’s a statement about how the agency views your quality system.And the moment you receive one, the clock starts ticking.The days and weeks that follow are critical. How you respond to a 483 says more about your organization than the inspection itself. The content, structure, and tone of your response tell the FDA whether you’re serious about fixing the is..
Streamlining Regulatory Documentation - Tools and Techniques
Regulatory documentation is a critical component of compliance in industries such as pharmaceuticals, medical devices, and biotechnology. However, the process of creating, managing, and maintaining regulatory documents is often complex, time-consuming, and prone to inefficiencies. Organizations must navigate evolving regulatory requirements from agencies like the FDA, EMA, and ISO while ensuring documentati..
Computer Software Assurance (CSA) Implementation with Focus on Industry Case Study
Computer Systems Validation (CSV) and Computer Software Assurance are both crucial aspects in ensuring compliance, reliability, and security in an FDA-regulated environment, but they differ in focus and execution.Objective: Understanding the distinctions between Computer Systems Validation (CSV) and Computer Software Assurance in FDA-regulated settings.Importance: Highlighting their roles in ensuring regula..
Streamlining Validation of FDA-Regulated Systems: Knowing When You Are Doing Too Much or Not Enough
The data integrity principles of “ALCOA+,” Attributable, Legible, Contemporaneous, Original or “True Copy,” Accurate, Complete, Consistent, Enduring, and Available must all be met for FDA-regulated data. These must be tested and confirmed during validation of the FDA-regulated system.We will discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately, in accordance ..
FDA Warning Letter - Consent Decree Software Validation
Computer system validations play a crucial role in the pharmaceutical, medical device, and many other FDA regulated industries to ensure the integrity, security, and compliance of critical computerized systems. Inadequate software validation can often lead to FDA 483s, Warning Letters, or even Consent Decrees. Deficiencies in these validations can have a significant impact on product safety and quality that..
Top Ten Best Practices for Establishing a Coherent Validation Compliance Program to Support a Diverse Technology Landscape
We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of 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 discus..