All FDA Regulated Industry
Sample Reanalysis
Sample re-analysis may be required for numerous reasons. Assay failure is the most common and the clearest. Individual re-analysis is usually justified by the lack of internal standards or the failure to meet chromatographic parameters such as retention time or peak shape. In ligand binding assays and chromatographic assays, the color or peak height may exceed expectations or fall below expectations. These&..
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..
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..
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..
21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.Areas CoveredCompu..
5 Key Components of Good Manufacturing Practices to obtain cGMP certification
Pharmaceutical and other FDA-regulated industries are tasked with safely manufacturing products for people (or animals) around the world. The FDA has set specific requirements, known as cGMPs) for facilities to meet the standards for a product to be deemed safe, pure, and effective. Good Manufacturing Practices are critical to any organization that produces products for the public. This training will discus..