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..
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..
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 ..
Computer System Validation (CSV) Boot Camp
We will explore the best practices and strategic approach for evaluating computer systems used in conducting 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..
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..
Effective GxP Instructions Writing
Standard Operating Procedures (SOPs) are the backbone of Good Practice (GxP) compliance in the pharmaceutical, biotechnology, and medical device industries. Yet, despite the critical role SOPs play in daily operations, companies continue to invest significant time and money into writing, maintaining, and training employees on SOPs, without offering meaningful training on how to actually write them effective..
How to create an effective and GMP compliant Training Program and reduce Training related human errors
Training programs have evolved. Human reliability or human error is usually attributed to training effectiveness or training program weaknesses/strengths. Even though the training is considered the “vaccine for mistakes,” training is not responsible for most human error deviations. To ensure training programs are effective and can be ruled out as a root cause for human error deviations, we will discuss the ..
Clinical Trial Systems: Trial Master File (TMF) and eTMF, And FDA’s Recent Draft Guidance for Electronic Records/Signatures Used in Clinical Trials
Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after the conduct of a clinical trial, and must be submitted to support the request for product approval. This is true for pharmaceuticals, biologics, and medical devices. More recently, tobacco and tobacco related products have come under regulation by FDA, and will also be discu..
Compliance Audit Using Principles of Lean Documents and Lean Configuration
This webinar describes:Enhance your knowledge: Compliance auditing is a critical aspect of any organization's governance framework. By attending this webinar, you will gain a comprehensive understanding of compliance auditing principles, methodologies, and best practices. This knowledge will enable you to strengthen your compliance program and contribute to your organization's overall risk management strate..
Computer Software Assurance: Use Industry Standards To Be Efficient and Compliant
This webinar addresses the Computer Software Assurance guidance related to 21 CFR Part 11, and the European equivalent Annex 11 for local and SaaS/Cloud-hosted applications. It details the evolution of industry practices that increase productivity and ensure compliance. Learn the latest validation models and fill-in-the-blank templates. Learning ObjectivesWhich data and systems are subject to Part 11 a..
Problem solving effective root cause analysis techniques
Effective problem-solving is a cornerstone capability for any professional aiming to achieve success and sustainable improvements within their organization. While issues and challenges are inevitable in any workplace, how these problems are approached and resolved significantly determines the success and longevity of solutions implemented. Root Cause Analysis (RCA) is an essential method designed to not jus..
Data Integrity and Privacy: 21 CFR Part 11, Annex 11, and General Data Protection Regulation (GDPR)
Documents contained in the TMF must be available for inspection by the appropriate regulatory authorities at any time during and after the conduct of a clinical trial, and must be submitted to support the request for product approval. This is true for pharmaceuticals, biologics, and medical devices. More recently, tobacco and tobacco related products have come under regulation by FDA, and will also be..
Critical Risk Assessment for Software Validation
Revolutionizing CSV: Embracing Critical Thinking, Risk Analysis, and Cutting-Edge Tools in an Evolving Tech LandscapeDemonstration of Risk Assessment ConceptsDemonstration of Risk Assessment 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 Ca..
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..
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..