This session explores the elements required for a successful technology transfer between various sites. It is intended for anyone who may be involved in the transfer of information between groups or sites. This includes both internal transfers as well as transfers to a third party. Upon completion of this session, the attendee will have a greater understanding of the process and what is required to ensure a..
Most people find it challenging enough to work well with even ONE boss. But if you're working with two bosses – or MORE – the challenge may seem nearly insurmountable. Dealing with the workload is tough, but now you've also must manage multiple communications styles, sets of expectations, schedules, projects, and more. This can mean multiple headaches. Even if the "official” designation is 50% of your time ..
FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they should be conducted and establishing specifications for success.Areas CoveredGeneral InformationSpecificityAccuracyPrecisionSensitivityLinearityRange..
HIPAA and the Administrative Subpoena – How HIPAA Does or Does't Protect you When the Government comes Calling for your Patient Records and you are in Trouble
This webinar reviews core privacy requirements of HIPAA then covers in detail the ways state licensure boards and agencies use the authority of state law to cover HIPAA exceptions and gain access to your patient records. This webinar shows how state agencies use state law in concert with HIPAA exceptions to conduct government-lead investigations. These exceptions can also be used by federal agencies in the ..
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..
What’s the best way to avoid expensive and time-consuming payroll errors? Why, avoid them, of course! In this webinar, you’ll learn tips and methods to verify all your payroll variables before you commit a final payroll to your IT team or your outside processor!You’ll learn: how to create the most efficient checklists for your pre-processing checks; the best way to create your calendar for a full year..
Even a detailed and well-written standard operating procedure for a method cannot ensure that 2 laboratories running on aliquots of the same will get statistically equivalent results. Using different instrumentation, standards, reagents, solvents, and other chemicals, data systems, sample storage, and handling procedures, and other variable are common and can lead to different results. Making each operation..
Margaret Thatcher said: “Think of a day when you are supremely satisfied. It is not a day when you lounged around and did nothing, but a day when you had everything to do and you did it.” If this speaks to your daily purpose and emotional makeup, sign up for this webinar. Projects, deadlines, bosses, and your internal psychic all scream for ways to check off more items on your task list in a short amo..
Using a library of SOP’s to help organize and control your operations is just good business sense. This is particularly important in high-risk and critical operations, construction or industrial, where a mistake can be costly or result in catastrophic accidents or failures.One of the prime reasons to create an SOP is to predict and eliminate incidents, errors, accidents, failures, poor quality outcomes, etc..
Social Media has been around for more than a decade now, and old posts from when we were younger could come back to haunt us in our personal and professional life. Learn the steps you need to take in five of the most used social platforms to put your best foot forward. Plus, walk away with guidelines on personal and professional use of social media. This class covers Facebook, YouTube, Twitter, Pinterest, a..
This program will provide the participant with the U.S. federal income, estate, and gift tax implications and planning techniques to properly advise their foreign investor clients on how to best structure their U.S. real property investments under the new tax rules of the Tax Cuts and Jobs Act.Advising foreign real property investors requires tax and other professionals involved with foreign real property i..
Your biggest question should be: Why have a meeting? There needs to be a compelling reason.We will review various types of meetings and define the purpose of each as well as exploring alternatives to holding meetings. Depending on your real purpose, a meeting may not be the best way to accomplish the goal. Once you determine that a meeting is the best solution there are several questions that need to be ans..
Import FDA in the Automated Commercial Environment (ACE) Authorized Electronic Data Interchange (EDI) System
It focuses on the role of the import managers when shipping goods under the FDA and Customs Regulations. It also addresses what regulations can be used to help the importer in understanding Automated Commercial Environment (ACE) as the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Certain Electronic Entry and Entry Summary Filings Accompanied by Food and Drug Administration (FD..
Agreeing to an FDA foreign inspection requires careful preparation on a firm’s part. If you do not manage your inspection wisely, you will set yourself up for disaster. We will cover fundamental issues, such as pre-inspection tasks, preparing your documents and having an interpreter before, during and after the inspection. We will also address how you should respond to inspectional problems noted by the FDA..
You know you’re good at your job, and you know what needs to be done. But sometimes, despite your best efforts, nontechnical colleagues can’t wrap their minds around what it is you’re telling them. As a provider of customer service in a technical field, you need to interact with customers to address their technical concerns. To do this effectively, you need to develop skills that will help you interact with..