Aseptic technique, in sterile compounding, contributes in preventing microbiological contamination. Aseptic technique is being used to provide safety, efficacy and sterility to the products that are s...
The FDA's expectations for training new employees are summed up in 21 CFR 211.25(a), i.e., pharmaceutical professionals require the education, training and experience to complete their job functions. ...
The FDA governs the computer systems used to collect, analyze, transfer and report data that is in support of human clinical trials required for drug approval. FDA oversight is based on a Predicate Ru...
Standard Operating Procedures and work instructions – the documentation required by regulation – is essential to the effective and compliant running of any regulated business. Unfortunately, many indi...
FDA implemented the new Food Safety Modernization Act (FSMA), including the hazard analysis and risk-based preventive in 2016 to help industry manage potential hazards in producing safe food...
The inherent molecular heterogeneity of metastatic tumors and the ability of cancer genomes to dynamically evolve are not properly captured by surgical or bioptic specimens. The analysis of circulatin...
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rat...
The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key t...
The US and may other countries are in the midst of a large epidemic of addiction to opioids and all of the problems to society that this uncovers. One area not talked about is the effect on Clinical R...
Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy. They are in the top five a...
This webinar focuses on fraud in the corporate environment. It reiterates some of the authoritative CPA literature related to fraud. It is, however, equally important to non-CPAs (e.g. internal audito...
Bitcoins have been adopted by a wide range of user – the good, the bad, and the ugly. Understanding how they and the block chain operate is essential to preparing for is further adoption and incorpora...
This 90-minute session will focus on how when debits are added, and the impact this may have on ACH Processing – for the RDFI and the Receiver. Authorization language – the impact it has on Same Day D...
For an auditor working in today's business environment, a basic understanding of the concepts and controls governing the use of computer systems is essential. This webinar is designed to give a basic ...
This webinar provides internal auditors with important information about how to approach their company’s audit of internal controls. It presents an overview of the current role of the modern prof...
Some ratios focus primarily on the revenue accounts, while other focus on the related accounts. Remember, if there is a fraudulent credit to revenue, there must be a fraudulent debit somewhere else in...
In light of recent legislation changing the Internal Revenue Code many accountants are realizing they are not quite "up to speed" on the accounting for income taxes, particularly the handling of defer...
In recent years the increased use of electronic means to obtain customer signatures, to conduct verifications of customer information, and to conduct overall customer due diligence has posed problems ...
According to the NACHA Operating Rules, the ODFI takes on all the warranties and responsibilities for each and every ACH Entry they transmit into the network, What does this mean? What about the Origi...
ACH Returns can be complicated and requires attention to detail. In the ACH network, for years, returns have been sent – typically with financial institutions processing exception items on Day 2...
With merger and acquisition activity at an all-time high, accountants need to know how to apply IFRS 3 - Business Combinations. They are expected to know the rules for integrating the acquired company...
This webinar is designed for professionals in every bank and credit union area to develop and maintain payments as the core business practice for their customers. Every transaction includes a payment ...
This course, designed for all auditors, provides a working definition of "financial instruments." It identifies the typical derivatives (e.g. futures, forwards, options, swaps) and provides illus...
California Employers! Effective January 1, 2018Unfortunately, recent media and political cases has put sexual harassment in the forefront in the workplace. If you thought sexual harassment and workpla...
Are you overwhelmed or scared and at the thought of OSHA conducting a walk-through of your facility? Many owners, plant managers, supervisors and even safety professionals are overwhelmed and of...
Your message may be a very important one but if no one is willing to listen, its value will be lost. Effective Communication is a commonly used phrase; wherein, effective basically means being success...
In today's diverse workplace is a reflection of North American society at large. Often we see a wide range of behaviours that display a lack of respect and politeness, both inside and outside the work...
This workshop will focus on the serious issue of sexual harassment and how to prevent it in the workplace. It provides an overview of sexual harassment, sex discrimination its definition and the laws ...
Would you like to understand the complete and critical steps of the 360 degree feedback process?. How about learning the keys to identifying an effective 360 degree feedback instrument?How about being...
The demographics of the workforce are changing and companies are struggling to keep up with the challenges that can be caused by ignoring this elephant in the room. Are you an employer of choice? If n...
The Occupational Safety and Health Administration (OSHA) regulates the health and safety of the American workers. OSHA uses many tools to keep workers safe and employers accountable for following regu...
Doing the work is one thing and now supervising other or managing others are new challenges, which will be much easier if you understand the new expectations that people have of you. There are new peo...
Management is both a science and an art. The science is in making people more effective than they would have been without you. The art is in how you achieve that. We will help you more effectively use...
This webinar focuses on fraud in the corporate environment. It reiterates some of the authoritative CPA literature related to fraud. It is, however, equally important to non-CPAs (e.g. internal audito...
Global teams demand special attention to differences in culture, communication barriers, and inherent trust existing among the team members. A lack of cultural awareness in a multicultural envir...
Learn to properly use Project Management Principles to prepare for an impact to the business for any organization. We will cover how to identify, analyze and document the events and environmental surr...
Participants in this webinar will learn about the three broad and overarching strategic objectives of the 2018-2022 EEOC strategic plan, outcome goals for each objective, and strategies of how to reac...
Increased Revenue & Profit For Your Practice!....Better Service & Outcomes For Your Patients!....From Your Existing Patient Base! ✔ Increase Profits $3,000-$15,000 Per Month, Per Doctor&...
I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I’ve been on both sides of these audits) what your highest risks are for being fined (some of the ris...
The Centers for Medicare & Medicaid Services
(CMS), in collaboration with public and private partners, are
transforming how they conduct business and operations, connecting
providers, and em...
This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under ...
All practices are facing the fact their professional services reimbursements are shrinking from all insurance companies & especially Medicare. Patient loads are smaller due to the economy and oper...
This lesson will be addressing how practice/business managers (or compliance offers) need to ensure their organization is complying with the Federal Substance Abuse and Mental Health Administration (S...
In this session, Mr Wolfe will provide an overview of the Anti-Kickback and Stark Laws and their fair market value and commercial requirements. He will distinguish between what is legally required, wh...
This session will discuss the roles and functions of staff in a case management department that are needed to support the department’s goals though collaborative professional processes. The skill sets...
All practices are facing the fact their professional services reimbursements are shrinking from all insurance companies & especially Medicare. Patient loads are smaller due to the economy and oper...
Instrumental gas chromatography, either as GC or GC-MS, are common techniques in laboratories that do regulatory-compliance work. For Good Laboratory Practice (GLP) or for ISO 17025 compliance, such m...
Everyone in a laboratory under compliance knows about 3-sigma out-of-control issues. Can the operation be monitored to avoid these? How? This webinar will cover the basic statistics of compliance and ...
An out-of-compliance under GLP or ISO 17025 is a discreet and specific event. Its occurrence has major consequences for the laboratory operation. Can the incident and its timing give clues to that cau...
Method validation involves assessing the results of an analytical methodology to prove that it meets all of the requirements that its output, the data, must have. This two-hour presentation covers the...
Smarter Time Management helps participants learn how to organize their time, mind, spaces and information. Without awareness of new, smarter time management practices, many people will find themselves...
With shifting corporate cultures requiring change managementexpertise, this webinar focuses on the mindsets, practices and emotional intelligence of the leader or aspiring leader. Discover not only ho...
It’s a common question: if you are building a sophisticated model in Excel, what are the key functions you need to know? This webinar discusses the “dirty dozen” – the top 12 functions professio...
Need to keep your budgets up to date automatically? This session will show you how to create a dashboard summary of budget performance displayed tabularly and graphically using simple Excel ideas wher...
Dread budgeting season? Wish your team worked more collaboratively in preparing forecasts? If so, then this session is for you. This session shows how finance practitioners can work collab...
Not often do we prepare an Excel webinar dedicated to the use of one Excel function. But the OFFSET function warrants it. It’s incredibly versatile and useful for the world of modelling, spreadsheets ...
-500x445.jpg "FDA Compliance and Clinical Trial Computer System Validation")
-500x445.png "The Effect of the Opioid Epidemic on Clinical Research")
-500x445.jpg "Fair Market Value and Commercial Reasonableness in Physician Transactions: Complying With the Anti-Kickback and Stark Laws")
.jpg){kind=link}
.png){kind=link}
.jpg){kind=link}
