All FDA Regulated Industry
Navigating the Complexities of Newer Technologies When Validating FDA-Regulated Systems
Advancements in technology have forced companies 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 have 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 system ..
Effective Technical Writing for FDA Submissions
Technical Writing for FDA Submissions is a critical skill for professionals in regulated industries, including pharmaceuticals, medical devices, and biotechnology. Regulatory submissions to the U.S. Food and Drug Administration (FDA) must be clear, precise, and well-structured to ensure compliance and facilitate regulatory review. Poorly written submissions can lead to delays, requests for additional inform..
FDA 483 or Warning Letter? Now what?
The training on “FDA 483 or Warning Letter – Now What?” is designed to empower professionals in FDA-regulated industries with the knowledge and skills necessary to respond effectively to regulatory challenges. FDA 483 observations and Warning Letters signify potential non-compliance issues that require immediate attention to avoid escalated enforcement actions. This webinar provides a comprehensive roadmap ..
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..
Applying Six Sigma "Downtime" in the Bioanalytical Lab
Applies the consideration of the acronym "DOWNTIME" to improve function and efficiency in the LAB. - Defects- reduce or eliminate - Overproduction reduces waste of materials, time, and personnel - Waiting to eliminate waiting on resource access or permission - Non-utilized resources- instruments, personnel - Transportation-movement (temporal or spatial) of resources/or documents&nbs..
The Human Error Toolbox: A Practical Approach to Human Error
Human error is known to be the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment, many variables that affect human behavior can be managed, reducing the likelihood of these occurrences. When wor..
21 CFR Part 11 and Annex 11 Compliance; specifics needed to eliminate 483s when using SaaS/Cloud
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local and SaaS/Cloud-hosted applications. It explains how to write a Data Privacy Statement for compliance with the EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, s..
Unlocking Manufacturing Effectiveness: Practical Strategies for Overcoming Production Constraints
In today’s fast-paced manufacturing environment, being busy doesn’t always translate to being productive. Operations that appear smooth on the surface may in fact be stagnant—or even declining—in terms of output. The hidden culprit is often an overlooked constraint or bottleneck quietly limiting the entire system’s performance.In this session, industry expert José Ignacio Mora shares a practical approach in..
Essentials of Post Market Surveillance and Vigilance - Do you know the requirements?
The post-market phase of a product’s lifecycle is as crucial as its development and pre-market phases. Once a product reaches the market, its real-world performance, safety, and effectiveness must be closely monitored to meet regulatory requirements and ensure patient safety. Post Market Surveillance (PMS) and vigilance programs are essential tools in identifying potential risks, mitigating issues, and driv..
How to Prepare for an FDA Inspection
FDA inspections are not just routine regulatory encounters — they are high-stakes, high-visibility events that can impact your organization's reputation, product pipeline, and commercial success. Whether you’re a pharmaceutical manufacturer, a biotech startup, or a medical device company, your inspection readiness reflects not just your documentation, but your culture, your leadership, and your operational ..
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..
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..
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..
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..
Critical Risk Assessment for Software Validation
Revolutionizing CSV Embracing Critical Thinking, Risk Analysi,s and Cutting Edge Tools in an Evolving Tech LandscapeDemonstration of Risk Assessments ConceptsDemonstration of Risk Assessments Tools and StrategiesPivoting Away from Traditional Risk Assessments and Encompassing Critical ThinkingPivoting from CSV to CSA with Critical Thinking/Risk Assessment in MindReal World Highlights of CSA Implementation C..