All FDA Regulated Industry
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..
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..
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 ..
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..
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..
Real Life Case Studies in AI/ML
Real Life Case Studies featuring ML/AI, including Predictive Maintenance, Defect Detection, Environmental Monitoring, CAPAs, etc.Demonstration of Foundation of AI/MLDemonstration of Real Case Studies in Industry (non-Life Science)Demonstration of AI Validation Workflows and ProcessReal Life Case Studies featuring ML/AI in Life Sciences, including:- Predictive Maintenance, - Defect Detection,- Environmental ..
Data Process Mapping
Using Process Mapping in Data Integrity Governance.Demonstration of key issues 483s and Warning Letter Trend in Data IntegrityDemonstration of Data Process Mapping Assessments ConceptsDemonstration of Data Process Mapping Tools and StrategiesUtilization / Latest Industry Trends in Data Process Mapping with Data Integrity GovernanceIntegration of data process mapping is a vital component of effective data go..
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..