We will discuss the importance of classifying computer systems subject to FDA regulations in accordance with GAMP V. 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 you do not go beyond what is required for a specific classification of the system so as to be cost-effective...
Do you face daily dilemmas trying to figure out where to start on your task list? Task lists can be overwhelming with a great range of items to complete. Some can wait but others are urgent and demand immediate attention. When you have 5 or 6 urgent requests at one time, the choice of which one to work on first can be agonizing. The principles taught in this program solve the puzzle for you. You will learn ..
This 60-minute presentation will highlight the use of statistical tools to monitor operations for a proactive operation.There are always certain steps in a method where control is critical either because this step contributes a lot to the overall uncertainty or its uncertainty is more likely to change from common causes. These critical points can be assessed and a monitoring program instituted. This data is..
De-escalation, diffusion, Verbal Judo, or “talking someone down", are all names for keeping the potentially violent person from becoming an actual violent person. This program will provide strategies, tactics, and techniques for keeping situations from devolving into dangerous confrontations. We’ll take a quick look into the problem of workplace violence, how often it happens and what is the effect on indiv..
Having a competitive and well-designed compensation system is the cornerstone of employee recruitment and retention for most organizations. But did you know, that 30 percent of U.S companies have no formal pay structure in place? And that number increases for small businesses - 50 percent of companies with 100 employees or less are lacking a proper compensation system. When you have an ill-designed or inade..
Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room. As the FDA Guideline on Aseptic Processing GMP (2004) states: “In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing..
This course will address the management of an electrical safety program. The effectiveness of a program starts with the highest level of management setting the tone and allotting resources. Funds are allotted for training and for Personal Protective Equipment. The program must determine what work can be performed by in-house personnel and which must be done by Journeyman electricians. The program must also ..
Accounts Payable (AP) is the one business function that, in many organizations, is more vulnerable to fraud than any other. That is because all funds that flow out of the organization must first pass through AP. And over time, dishonest insiders and vendors have created newer and craftier methods of stealing from organizations by exploiting control weaknesses in the AP function.Result: It is more important ..
Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. Following best practices for developing a validation program that includes planning, execution and maintenance components will ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more ..
One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consum..
According to Deepak Chopra and Kabir Sehgal in a post for CNBC, one way to deal with difficult people is to not take what they say personally. If you do then you both get defensive and the situation escalates.This session shows you how to deal with the event, the situation, not the person. Position yourself as a cooperator, not a competitor, working together, not against each other. Gain some quick tips and..
An entity with foreign activities may have transactions in foreign currencies or it may have foreign operations. IN either case, IFRS permits some reporting choices. The company some may present its financial statements in a foreign currency. This session will outline how to include foreign currency transactions and foreign operations in the financial statements and how to translate financial statements int..
This webinar will give a general overview of the types of deductions that employers take from an employee’s check. We will review the laws that surround all types of deductions you can take with or without employee consent along with proper calculation of the deductions. This webinar will give you the knowledge to be sure that how you process employee payroll deductions are in accordance with the law for bo..
The Proper Way to Correct I-9 Documents and Not Pay Penalties! Use New Tools Accepted by the Department of Homeland Security (DHS)
Free for All Attendees: I-9 Correction and Storage Toolkit Accepted by DHS!I was one of 3 compliance auditors who reviewed over 7,000 I9 documents from an agricultural farm in Florida in 2012. We were hired when the company was audited for I9 document violations and the possible violation for hiring illegal immigrants. It was the start of when regulatory agencies were cracking down on immigration hiring and..
One of the most critical areas of employee relationships--and one of the biggest challenges management faces today--is conducting effective performance appraisals and determining appropriate merit increases. Learn to give performance appraisals that help motivate employees to achieve goals and increase their value to the organization. Since both managers and employees often view performance appraisals with ..