All FDA Regulated Industry
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..
Writing Clinical Study Reports with clarity and Precision
Writing clinical study documents with clarity and precision is essential for ensuring accurate communication among regulatory agencies, clinical investigators, ethics committees, and other stakeholders. Clinical documents, such as study protocols, investigator brochures, and clinical study reports, serve as the foundation for regulatory submissions and decision-making. Any ambiguity or lack of precision can..
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..
Process Validation Requirements And Compliance Strategies
When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.Areas CoveredGlobal Harmonization Task Force requirements (includes FDA and ISO)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Design QualificationFacilities and utilitiesStrategies for achieving a robust and reliable process.Typical..
Statistical Process Control through the use of control charts and Nelson’s Rules
Control charts are based on the normal distribution of data expected in a laboratory operation, the Gaussian distribution of occurrences. There are well-defined probabilities for the data. Whether it is the overall performance of a test method, the performance of a device or instrument, the behaviour of a calibration curve, the peak shapes in chromatography, or many other variables, the maintenance of good ..
Compliance Auditing and Monitoring - Techniques for Auditing Compliance and Monitoring Adherence to Regulations
Compliance auditing and monitoring are critical components of an organization's risk management strategy. These processes ensure that companies adhere to regulatory requirements, industry standards, and internal policies, helping to avoid legal penalties, reputational damage, and financial losses.Compliance Auditing involves a formal, structured evaluation of an organization’s processes, controls, and recor..
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 ..
5S for Operators and Human Error Reduction
Human error is the primary cause of quality and production losses in many industries. Although human error is unlikely to be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce human error is the “5S Method.” This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler, and organized, helping yo..
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..
Digital Phenotypes, Digital Twins, and N of 1 Data in the Design of Personalized Measurement-based Clinical Care
The technology currently available for quantifying various biometric, behavioral, emotional, cognitive, and psychological aspects of daily life has become increasingly diverse, accurate, and accessible, with ongoing and continuous improvements. These burgeoning technologies can and will profoundly alter the way lifestyle, health, wellness, and chronic diseases are managed in the future. For those pursuing t..
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..
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..