Leading in a time of crisis can be a heavy burden to bear. Leaders may feel the pressure of needing to have all the answers to get their teams through the situation with as much support as possible. All while feeling a sense of strain and fear themselves. Though most people are not usually ready for a crisis, they know that they will come.
When organizations are trying to survive a changing market, considering a reboot of their business, or want the flexibility to enter a new market, the question is how do you make the competitive analysis actionable?
Creativity is an enormous opportunity for HR practitioners! There are methods you can use to improve creativity across the board, including hiring, performance management, retention, engagement, innovation, etc.
You've likely experienced the challenge to think of your time in terms of money. More specifically, if you've ever gone to a time management training course, you have probably been told you have 86,400 seconds in a day and each of them is worth something.
Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time.
If specifications are too wide,the risks of inadequate product performance and product failures increase. If specifications are too tight, the costs to ensure conformance increase.
The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes.
For food shippers, carriers and receivers, standardization or upgrade to current practices is critical. For buyers, knowing how to establish standards for your food transporters sets the stage for required supply chain controls.
The journey from "Where do we start?" to "We are compliant food safety carriers." begins here and establishes a basis for meeting newly evolving FSMA food safety during transportation requirements.
Human error is known to be the major cause of quality and production losses in many industries.
Although it is unlikely that human error will ever be totally 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 manipulated reducing the likelihood of these occurrences.
This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity, and explains about the regulation and how it applies to computerized systems.
This webinar discusses many issues present in any sample size determination, Also discusses several common applications that require an appropriate sample size determination including Reliability Demonstration/Estimation, Estimating proportions, Acceptance Sampling for Lot Disposition, and Hypothesis Testing.
In this webinar speaker will explain about CAPA System, A company's CAPA System is supposed to be a major tool in resolving product complaint, non-conformance, and focusing OOS failure investigations, and hazard analysis / risk management and mitigation activities, And Failure Investigation and Root Cause Analysis are the foundation for proper CAPA, verification and Validaiton, Inspection / Audit resulutions, and other basic CGMP requirements.
There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.
GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance.
In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier under the old MDD, and the Technical Documentation requirements of the new MDR. Currently they serve differnt purposes, support different goals, but the TD File is moving in the direction of the DHF.