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Risk Management for Medical Devices per ISO 14971
Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.During all phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or the environment during all stag..
Sampling by Variables (ANSI/ASQ Z1.9, formerly MIL-STD 414)
ANSI/ASQ Z1.9 (formerly MIL-STD 414) is an acceptance sampling plan that uses the average measurement of a sample, and its range or standard deviation, to determine whether a production lot should be accepted. This webinar will show how to select and use sample plans.Attendees will receive a pdf copy of the slides and accompanying notes, and an Excel spreadsheet that converts a traditional sampling plan i..
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..
Microbiome: Ideas, Approaches, Regulatory, Integrative Technologies, and Future Directions
The microbiome is a little-understood aspect of human physiology. Microbiomes are found mainly in the gastrointestinal tract. However, simulation of microbiomes is increasingly needed to understand both the flora and fauna of microbial and its synthesis in modern biotechnology process systems.Flora and Fauna identification and speciation are part of this system, using either traditional incubation and..
Basics of Clinical Trials
Useful for those entering the pharma industry or academics to understand how clinical trials are conducted. The study objectives, endpoints, entry criteria, study visits, evaluations, safety assessments, statistical considerations, manufacturing and compound supply, and regulatory considerations. The design of randomized, placebo studies can be open-label or blinded (single, double, or triple-blinded). ..
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..
Narrow Limit Gauging
Narrow limit gauging, which relies on tightened acceptance limits to assess the quality of a sample, can enormously reduce the required sample size and therefore the cost of inspection. This webinar will equip attendees to convert any ANSI/ASQ Z1.4 (formerly MIL-STD 105) sampling plan into a narrow limit gauging plan.Learning Objectives A review of the basics of ANSI/ASQ Z1.4. A major takeaway is..
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 ..