In order to succeed you need employees to think critically and solve problems on their own. Average managers make a critical mistake that prevents their employees from gaining these skills. In this practical and engaging program, get the skills to avoid this mistake and gain the must-have skill for any manager or business leader: employee coaching. Using simple, but powerful coaching techniques, can create ..
CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture
A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety, and efficacy of the manufactured drug. Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:EU GMP Chapter 7 "Outsourced Activities" January 2013Guidance for Industry -..
Anger, verbal aggression, and arrogance are epidemic in business and professional life. Learning how to de-escalate these situations quickly and effectively is, therefore, a critical leadership skill. In this webinar, you will be introduced to a counter-intuitive, yet powerful, set of skills that will allow you to de-escalate any angry situation in seconds without being defensive or anxious.We are 98% emoti..
The NACHA Operating Rules and Guidelines require that all participating depository financial institutions, third-party senders and third-party service providers that provide ACH services conduct an annual ACH audit to be performed by December 31 of each year (ACH Rules, Appendix Eight). By each participant performing the annual ACH audit, this helps to ensure that electronic payments work safely and efficie..
Overview of FDA FSMA (Food Safety Modernization Act), a rule which became effective in September 2016 for the food industry. The new regulations have shifted from a reactive FDA focused primarily on GMP’s (Good Manufacturing Practices) to a preventative approach placing responsibility on the food industry to mitigate their potential hazard risks for foods. Highlights will include an intr..
Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meet all required regulations, especially for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that yo..
Gain the insights and skills to know where your business stands today and where it’s heading tomorrow.In today’s unpredictable business environment, strategic leadership is not just for top management alone. It’s for:Managers who want to increase their competitive advantage by anticipating their customers’ priorities, needs, and expectationsManagers who want to distinguish operational data from strategic da..
This session is designed to help you and your team generate a cordial and productive office environment where employees interact assertively and professionally. The session concentrates on the introduction and thorough explanation of the seven pillars of good corporate etiquette as follows: (1) workplace basics, (2) electronic communications, (3) courteous considerations, (4) effective meetings, (5) profess..
This webinar provides an overview of the use of background checks during the hiring process – what are they typically and why are they used by employers. The Presentation will also discuss the potential discriminatory disparate impact the use of criminal background checks may have on applicant pools. New trends in the enforcement of anti-discrimination laws, particularly by the Equal Employment Opportunity ..
Over the years people have been lulled into believing that doing a presentation simply means preparing a PowerPoint filled with bulleted slides and then reading through them for the audience. Everyone that has sat through one of these presentations knows that they are boring and hardly anyone can remember what was said during the presentation. That is NOT how it was meant to be.This course will give you bas..
The Pregnancy Discrimination Act (PDA) is an amendment to Title VII of the Civil Rights Act of 1964. Discrimination on the basis of pregnancy, childbirth, or related medical conditions constitutes unlawful sex discrimination under Title VII. Women affected by pregnancy or related conditions must be treated in the same manner as other applicants or employees who are similar in their ability or inability to w..
Suppose one or more of your employees has taken a leave of absence, and your company or department is buckling under the added stress - and you suspect that one or more of those employees may be taking advantage, and may not really be in need of family or medical leave – or may even not be entitled to it. What if one or more of your employees ask for intermittent leave? Administration of continuous leave ca..
Human Factors/Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the n..
In the last couple of decades, the world has experienced growing prosecutions of intermediaries for cross-border financial crimes. A U.S. bank was convicted by a Spanish court for moving money in the Pinochet criminal investigation instead of freezing it. The U.S. and State of New York have brought criminal cases against banks for a variety of financial crimes, especially economic sanctions. The U.S. DOJ ha..
Employee morale is more important than you may think because it has a direct impact on productivity and profitability. When employee morale is high, employees are happier, more engaged and the quality of work produced increases significantly which allow companies to be more profitable. When morale is low there is a ripple effect and the result is a less productive work environment with higher levels of stre..