In today’s workplace, it is very important that employees feel valued and contribute to the performance process.Participants will learn the importance of effective performance evaluations, how to conduct them, how to engage employees in the process and how to handle difficult conversation during the process.Participants will be introduced to a simple solution when providing feedback- The CARE Approach.Learn..
The passage of the 21st Century Cures Act and the recent release of draft guidance from FDA signal changes ahead for the Humanitarian Use Device and Humanitarian Device Exemption Programs in the US.Whether you work strictly with medical devices, or with device combination products you will not want to miss the opportunities afforded by these changes. The requirements for qualifying for Humanitarian Use Devi..
Organizational units exist for various reasons. Nevertheless, governance focusing on business perpetuity and reliability should address strategic to operational transformations enabling adequate continuity management. When threading from the first-tier ‘Governance Tree’ level, linked leaves are inextricably affected by external forces. Consequently, an organizational formation’s continuity depends on releva..
Some regulatory guidelines mention the need of a QMS. But every company should have a library for its biggest asset – the knowledge of the employees.The reason to have a QMS is not to satisfy the regulators, but for any employee to find the reason for doing the work they should do and how it is connected to the rest of the company.Any of you who wants to do a good job needs to know the reasons, rules, and s..
Communication is a two-way process to exchange ideas. We communicate in order to elicit some type of response. Some examples of a response could be more knowledge, a specific action, or some type of emotion.Understanding the D.I.S.C. profile will help understand the four different personality type and how they like to receive information. Do you have a clear understanding of how to communicate with others? ..
The EU General Data Protection Regulation (GDPR) is the most comprehensive reform in data privacy regulation in over 20 years. The new law seeks to give individuals robust control over their personal data and establish uniform data protection rules across all EU countries. If your business collects or processes the personal data of any individual within the Union, it is subject to GDPR no matter where your ..
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by the FDA to train their inspectors to review your CAPA system, some of which you may not be familiar with.Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by whi..
In December of 2017, the Obama administration tried to change the requirements for claiming an employee was exempt from being paid overtime. That was challenged in court and was never implemented. It did, however, raise the awareness that the Fair Labor Standards Act was in need of revision. Thus the Trump Administration Department of Labor has been soliciting comments from the public on what recommendation..
Sterile Filtration of Pharmaceutical Products - What you need to know to meet Validation and Regulatory Requirements
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your par..
This webinar will provide an overview of the best tools to transform the planning cycle into an evolutionary process, bringing tangible and intangible returns for the organization. This is the most comprehensive condensed costing best practices course available!Whether a public company, private enterprise, or a not-for-profit organization, budgeting is vitally important to any entity.Learning ObjectivesSimp..
We will discuss in detail how computer system validation can be applied to mobile applications subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through r..
In this webinar, attendees will learn the difference between regular pay, gross pay and taxable gross, all of which may be different numbers! This can prepare the payroll team to respond to questions from employees who don’t understand their paychecks. We’ll discuss these questions: Do you know if any of your benefit plans are pretax? If you are in multiple states, are you aware of how each state regards Se..
Human resources analytics is a very hot area in HR today. Many HR professionals think it is new but it has been employed since the 90’s. Basically, analytics is a combination of analysis and statistics and unlike metrics which are data from the past; analytics is the use of data to make predictions about the future. This webinar will detail how, with the right data and skills, an HR professional can:Make pr..
Manufacturing in Mexico as a maquiladora under the IMMEX program (formally known as the Maquiladora Program) can offer tremendous benefits for virtually any foreign manufacturer, especially those selling into the North American market. Established in 1965 by the Mexican government as a way to reduce unemployment along the borders, the maquiladora program offers foreign companies easy access to inexpensive l..
The Risk-File according to ISO 14971 and how to deal with this file regarding the several requirements in countries, which require Risk-Files according to ISO 14971 e,g, Europe, MDSAP-Countries (_AUS, BR, CAN, JP, US). Another topic is how to deal with the ISO 14971 regarding the new EU MDR in Europe at 2020 how to be prepared for technical file submissions beginning this summer 2019 in Europe. Learn how to..