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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..
Selecting a CRO to Support GxP Analytical and Bioanalytical
This Webinar suggests objective components in the selection of CRO.Components include inspection and rebuttal of warning letters and 483 issued by the FDA or other regulatory entity, and answers/defense of the same by the CRO. Areas Covered Philosophy of the CRO to meet regulatory requirements, interpretation of suitability exercises. Philosophy of training skills and skill..
Dealing with Bad Data: Errors and Outliers in GLP
Assessment of the cause for non-compliance is a structured series of branching questions. The answers to these eliminate possibilities and eventually highlight a root cause. This process is described, including roles and responsibilities, timing, and efforts at prevention.In the case of an apparently anomalous data point, assessment of whether it really is an outlier using statistics is done. If so, an asse..
Designing Medication Adherence within a Patient Support Design Framework
Real-world outcomes have become an increasingly important metric for measuring value. Part of this value centers on the increasing emphasis on the patient (consumer) experience. To this end the industry needs to not only consider the standard “care” or utilization data that is currently available, but also (and perhaps more importantly) more deeply consider what data could or should be gathered if we are to..
Corrective and Preventive Action (CAPA) and Root Cause Analysis
Corrective and preventive action (CAPA) is required by ISO 9001:2015 and is also common sense; we don't want to have to solve the same problem more than once. The automotive IATF 16949:2016 standard adds additional requirements for root cause analysis. Inadequate CAPA and/or root cause analysis are leading sources of ISO 9001 and IATF 16949 audit findings, and also FDA Form 483 citations. A search for ..
Low-level Compound Testing
Low-level compound analysis has many differences from that of the more common analyses aimed at major components. The requirements for accuracy and precision are different. Selectivity to differentiate very similar compounds, such as isomers of the various types – substituent positional, optical, and alkyl are some – becomes critical since these may differ in toxic effects.The need for definitive qualitativ..
Crafting clear and compliant SOPs for Pharmaceuticals and Medical Devices
Standard Operating Procedures (SOPs) are essential documents in the pharmaceutical and medical device industries, serving as the foundation for compliance, consistency, and operational efficiency. Regulatory bodies such as the FDA, EMA, and ISO 13485 require organizations to establish clear, well-documented procedures to ensure product quality, patient safety, and adherence to Good Manufacturing Practices (..
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..