The increased focus on ethics for businesses and organizations of all types, even including government, is not only a socially commendable development but importantly has legal implications for liability for potential claims against them, their directors, officers, and managers. Having an Ethics Policy is thus not only socially responsible but internally wise.WHY?The law views ethics and agency as the twin ..
Best Practices for Using Your Quality Management System’s Quality Objectives and KPIs for Meaningful Process Improvement
Numbers, data, facts, perfect information all allow us to make more informed less risky decisions in every aspect of our lives. Due to the increased demands and business pressures to do more with fewer resources, decision-makers in every organization are tasked with making fast and informed decisions.Knowing how what to measure, how to measure it, what the data says where you are now, where you want to be i..
FATCA was enacted by Congress in 2010 as part of the HIRE Act. It attempts to restore tax fairness by focusing on foreign financial assets of US Citizens that are not being properly reported and taxed. With the announcement of final regulations in February, 2013, the US Department of the Treasury and the IRS have been busy designing, implementing and executing intergovernmental agreements, new and revised f..
It happens every year. Year-end is quickly approaches and that means putting the financial statements together and getting everything ready for the auditor. You can't avoid it, but you can make it an easier and less stressful.This course will look at every section of the balance sheet, income statement, cash flow statement, and the notes in order to anticipate what the external auditor will ask. The amount ..
Regardless of skill, hiring a person who is a bad fit is the wrong decision. In fact, traditional interviewing predicts future success by only 10%. With a bad fit, the employee is never going to reach optimum performance, be fully engaged, and they are likely to leave.The company is then left with another expensive recruitment along with the disruption of having talent walk out the door. (Recruiting expense..
When you sit down to eat lunch or dinner today, like us, most people will check their plate and utensils for cleanliness. Once the food is cleaned, processed and ready for transport, the packaging that carries the food through the supply chain should be sanitized and should protect the food from adulteration. Clean food should be moved in sanitary packaging. No food industry member should package or transpo..
Technical Writing generally conforms to Good Documentation Practices (GDocP). This term describes standards to create and maintain documents. Most companies have in-house procedures that all documents created within the organizations conform to the firms’ particular requirements. The purpose of this webinar is to define and clarify general guidelines for the creation and maintenance of documents in order to..
Disruption displaces an existing market or industry to produce something new and more efficient and worthwhile. It is at once destructive and creative. Disruption in the marketplace is driving a transformation of the supply chain into a more efficient and flexible framework that can support the continuous disrupting forces. This transformation of the supply chain is driven not only by a reaction to disrupti..
Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries
Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, the FDA issued dozens of 483 observations relating to topics governed by the quality agreement system. Furthermore, in November 2016, the FDA finalize..
Highlights will include an intro to Preventative Controls, leading into minimal recommended preparation steps for handling Prop 65 requirements, what’s needed to incorporate in your food Safety Plan, focus on hazards or Hazard Analysis Risk Preventative Controls (HARPC), Supply chain Preventative Controls and importance of compliance on Safe Harbor Limits.Areas Covered Details will includ..
A key driver to achieve these extraordinary results is based on an attribute called trust which becomes your behavior and your reputation. Here is how to achieve that with confidence, initiative, and commitment. This presentation outlines the eight key areas of focus and provides a link to the self-test tools and e-books to keep the momentum going. To be more successful, enjoy work and life more, get to you..
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability. Nevertheless, it is essential to understand human behavior and the psychology of error as well as underst..
Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.Learning ObjectivesDiscuss what to do when problems o..
The market for counterfeit and contraband or “pirated” products can be divided into two important areas. The primary market provides consumers with counterfeit and contraband products. These consumers believe they have purchased genuine products. However, these products are often below standard and can result in health and safety risks that range from mild to life-threatening. The secondary market pro..
• Making the Transition from Staff Member to Supervisor• Management Skills for New Supervisors• Confronting the Tough Stuff: Managing “Difficult” PeopleNew supervisors will be ready to hit the ground running with the skills learned in this Webinar. Be ready to take on any challenge, be your best and put what you’ve learned into practice immediately.You will learn the skills you need to plan, prioritize and ..