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..
This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and document modification. This document details the minimum documentation requirements for MEDIn still personnel, contractors and consultants completing cGMP documents. Specific operational procedures using more..
This webinar will introduce attendees to the foundations of statistical process control (SPC), including the effects of variation and accuracy on process quality. The definition of a Six Sigma process will be illustrated. Attendees will learn how to construct SPC charts that provide visual controls (easily understood signals) that tell production workers when the process requires adjustment to prevent the m..
This presentation will cover the fundamentals of measurement systems analysis (MSA), or gage reproducibility and repeatability, as required by ISO/TS 16949 and highly recommended otherwise. This includes the requirements in terms of parts and inspectors, as well as randomization of measurements, for a successful gage study as well as the mathematical calculations (which are in practice now handled by statis..
Attendees will learn how to calculate process capability and process performance indices that are often required by internal or external customers of manufacturing processes. The webinar will show the relationship between a Six Sigma process and its performance index. The webinar will then go beyond this textbook material to cover processes that do not follow the normal (bell curve) distribution, and for wh..
Traditional statistical process control (SPC) and process capability assessment techniques assume that the critical to quality (CTQ) variable follows a normal (bell curve) distribution. This condition is fulfilled far more often in textbooks than in real factories, laboratories, and so on. If the statistical distribution is not a bell curve, estimates of the nonconforming fraction (defects per million oppor..
A Leer, A Pat, A Joke, A Gesture, An Innuendo, A Kiss: Are You Prepared To Be the Next Social Media Blitz, Identified on #MeToo, or a Headline in the Newspaper?
Harvey Weinstein, Matt Lauer, Charlie Rose, Al Franken, Garrison Keillor, members of Congress, and various State lawmakers have been accused of sexual harassment and/or sexual assault. But there is a difference between pulling one’s pants down in front of a female colleague at work and touching a woman on her buttocks during a photo op—isn’t there? What is that difference? Are both examples considered sexua..
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, hospit..
This webinar will show how to expand Shingo maps from individual project applications into evolving, data-driven process documentation for an ISO 9001:2015 or related quality management system. Shingo maps support ISO 9001's process orientation, and also identify opportunities to reduce or eliminate wastes of time, material, and energy (muda). The latter applications support ISO 14001 and ISO 50001 as well ..
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 is widely used to determine purity, the impu..
This webinar will show how to use ANSI/ASQ Z1.9 (formerly MIL-STD 414) to define sampling plans for products with continuous-scale (variables) data, and use the accompanying switching rules to move between normal, reduced, and tightened inspection as required by the publication.ANSI/ASQ Z1.9 (formerly MIL-STD 414) is a widely accepted standard for sampling by variables (continuous scale measurements). The s..
Failure mode effects analysis (FMEA) and the control plan are both parts of advanced quality planning (AQP). FMEA, in fact, defines the control points or critical nodes of the control plan; process activities that must be controlled to ensure conformance of the critical to quality (CTQ) product characteristics. The dynamic control plan is a natural combination of the process FMEA and control plan into a sin..
This session with exploring the elements required for a successful transition from an early phase development organization to a “Commercial ready” manufacturer. It is intended for anyone who may be involved in the oversite and participation in the manufacturing and distribution of a potential commercial product. Upon completion of this session, the attendee will have a greater understanding of the process a..
Ineffective process management will result in a significant loss to organizations bottom line. The amount of loss depends upon your organizations Sigma Score, for example, a Sigma Score of 3 suggests a loss of 25% to 40% of sales (Sigma Scores vary from 2 to 6). A score of 6 suggests less than 1% of sales dollars are lost.Areas CoveredCost Justification: What is Your Organization’s Sigma Level Improvement T..
We will go over each principle described in ICH Q7, determine the meaning and exactly what to do to be in compliance. The principles that will be covered includeWho is responsible for the qualityParticipation of managementDefining and documenting all quality related activitiesThe independence of the quality unitThe need to specify specific individuals for certain tasksContemporaneous recording of quality re..