Quality and Safety
This webinar discusses how to select third parties, understand the direct and indirect risk, tools to protect your reputation, create controls and implement management practices that will facilitate understanding and enterprise-wide attention to this emerging risk area.All businesses outsource certain functions and or processes. It is efficient and usually good for business. However, not all businesses full..
An out-of-compliance under GLP or ISO 17025 is a discreet and specific event. Its occurrence has major consequences for the laboratory operation. Can the incident and its timing give clues to what caused the non-compliance?The records in a lab – the logbooks for chemicals, reagent and calibration solutions, for sample preparation, for instrument maintenance and calibration, for quality checks – all are ..
The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One hot topic is the focus on the “Post-Market-Surveillance-Process” and the new requirements e.g. reporting to Authorities and Notified Bodies and how this process is connected to other processes. The understanding of these changes and how to implement last-minute changes until May 2020 is essential to ke..
The purpose of verification and validation is to hunt for oversights and omissions in design, manufacturing, and servicing. Who is verifying and who is validating is a very important consideration. An independent, unbiased, and one with a full understanding of risk analysis would be an ideal participant. This is not always viable. The next best thing to then is to have a small team (5 to 7 people) to get a ..
Most manufacturing problems can be eliminated by better design of components and assemblies. One can call this approach the Design for Manufacturability, meaning the ability to produce the assembly without known defects. Then none or very little inspection is required, no rejects, no rework, no warranty costs, and therefore high quality at low cost!The tool of understanding production-related defects overlo..
Millions of US workers work remotely for US-based companies. Internal auditors, procurement engineers, supervisors, and managers are challenged to understand what is occurring in the global supply chain and how to conduct 1st, 2nd and 3rd party audits remotely. Virtual auditing presents a host of benefits to companies for the following reasons:Remote auditing replicates the emerging Remote workforce's envir..
The purpose of sterilization is to inactivate the microbiological contaminants on a manufactured medical device and thereby transform the non-sterile medical devices into sterile ones. EO (EtO, ETO, ethylene oxide) sterilization uses a highly reactive gas (100% or with N2) to accomplish this, and the method of proving this is defined by ISO 11135, the international EO validation standard. The webinar ..
Robustness analysis captures three types of risks: the risk of the known, the risk of known unknowns, and the risk of unknown unknowns. The known risks are understood through past history and customer statements of needs. Unfortunately, customers are not aware of many potential requirements until the device is functionally broken. This is the experience of this author working with many organizations. They r..
In this program, we will discuss the common statistics tools and techniques used for invalidation. Through real-world examples and interactive exercises, we will demonstrate the basic concepts of statistics and how to apply them to your validation projects. The discussion will center around measures of variance, sample distributions, and expressions of variance. The session will conclude with a discussion o..
This session will be highly interactive with audience members actively participating in an open discussion of their audit experience. Through discussion and examples, participants will gain an understanding of how to prepare for an audit, strategies to conduct and support a successful audit, and ways to respond to audit observations. Special consideration will be given to virtual audits as a result of the C..
Design reviews are supposed to identify all the requirements. The reviews must include three types of risks: the risk of the known, the risk of known unknowns, and the risk of unknown unknowns. But such analyses are often ignored or done too late. Developing good system specifications has become a worldwide goal, regardless of the industry and market. The best organizations around the world have become incr..
Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such methods must meet certain requirements. This presentation will cover the key elements to have a compliant method.Instrumental liquid chromatography is an analysis that is widely used to determine purity, imp..
CAPA is both a precursor to and component of RCA that helps people prevent non-conformances from occurring and if all else fails; answer the question of why the non-conformance occurred in the first place. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem. What is a non-conformance? When you have a non-conformance in the laboratory, how ..
The effective and progressive use of a Screening DOE, a Mapping DOE, and a Robust Process DOE will lead to a better understanding of the process and the location of the best optimum. NOTE: This webinar focuses on DOE strategies. It is not focused on statistical methods, analysis of variance, and other techniques, but rather the overall approach for successful DOEs.This DOE (Design of experiments) ..
A whistleblower or qui tam action can provide financial rewards to individuals who provide information that a company, hospital, or individual has defrauded the government. The primary statutes under which this relief may be sought are the federal and state False Claims Acts (“FCAs”). State and federal governments pay hundreds of billions of dollars each year for pharmaceutical drugs, medical devices, hospi..