Quality & ISO 9000 Compliance Management Training

This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.

This webinar presents an overview of essential quantitative methods for assessing and ensuring product quality. The methods include: Statistical Process Control, Process Capability Assessment, Regression Modeling, Design of Experiments, Hypothesis Testing, and Measurement Systems Assessment.

Achieving high product reliability has become increasingly vital for manufacturers in order to meet customer expectations amid the threat of strong global competition. Poor reliability can doom a product and jeopardize the reputation of a brand or company. Inadequate reliability also presents financial risks from warranty, product recalls, and potential litigation. When developing new products, it is imperative that manufacturers develop reliability specifications and utilize methods to predict and verify that those reliability specifications will be met. This presents a difficult challenge in many industries with short product cycles and compressed product development time frames. This webinar provides an overview of quantitative methods for predicting product reliability from data gathered from physical testing or from field data.

Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.

The webinar will provide useful methods and techniques for conducting a stability study and analyzing the resulting data for the purpose of estimating shelf life. Participants should be able to immediately apply the methods presented. Also, the interpretation and communication of results will be stressed and illustrated in several examples.

In this training, learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of lean vs. non-lean documents.

This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

Events in the world are affecting how we do business with travel restrictions we face new uncharted waters, Companies need to maintain their certifications / suppler status and are required to be audited either by a CB or a customer periodically. To protect the client and the auditor remote auditing has been proposed as the solution. The big question is how do we prepare for a remote audit? What are some challenges and how do we address them? Some guidelines have been flowed down from Certifying Bodies to their auditors. This session will share those guidelines and help you prepare for a successful remote audit.

This Quality management training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive Maintenance.

Corrective and preventive action (CAPA) is a process of the quality management system that begins with the identification of a problem (or opportunity), goes through a series of steps including identification of the root causes and deployment and verification of a solution, and documentation and deployment of lessons learned. The deliverables include not only elimination of the problem at hand, or realization of the opportunity, but application of the best practices learned to related activities.

Traditional process capability studies and statistical control methods rely on the assumption that measurements are available for all items. There are some applications, however, in which the gage or instrument cannot quantify measurements below a lower detection limit (LDL) and returns a measurement of zero (or "not detected"). Typical applications include pollutants, trace impurities, and trace contaminants. Statistical methods for left-censored data can be applied in these cases.

Attend this webinar to learn how to use DD2977 for relatively simple product realization processes, administrative processes of a quality management system, and services.

The Ford Motor Company of the early 20th century proved with bottom-line financial results that high wages are consistent and even synergistic with high profits and low prices. Henry Ford and his contemporaries such as Frank Gilbreth and Frederick Winslow Taylor recognized that enormous waste is built into most jobs at the expense of worker, employer, and customer alike. This webinar will show how the problem is usually correctable very easily once it is recognized, and also how to recognize it on sight.

The Automotive Industry Action Group's (AIAG's) and the Verband der Automobilindustrie (VDA) (German Association of the Automotive Industry) issued a substantial improvement on previous approaches to failure mode effects analysis (FMEA). This process is very well structured and user-friendly, and eliminates some of the drawbacks of the previous approach.

The coronavirus outbreak has caused thousands of deaths around the world along with extensive economic disruption. China has issued several overt threats to disrupt U.S. supply chains, and the stock market is in turmoil. This presentation will provide information on how organizations can position themselves to handle the disruption and even realize opportunities for improved performance as a result.

This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.

Attend this webinar to learn how to set up and use kanbans, JIT, pull system, and drum-buffer-rope in medical device and biotechnology manufacturing start-up operations. Also attendees will learn elements of lean documents and lean configuration, sterilization lot size, MRP II kanban system and how to use kanbans to track off-site sterilization and external supply chain suppliers.

This process capability analysis webinar will discuss the relationship between variation and accuracy, and process yield, short term versus long term variation, non-normal distributions and how to perform a process capability study.

In this training program, attendees will understand when and why to apply DOE (design of experiments). They will also learn to identify and interpret significant factor effects and 2-factor interactions and develop predictive models to explain and optimize process/product behavior. Applying efficient fractional factorial designs in screening experiments will also be discussed.