If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.

Human error is known to be the primary cause of quality and production losses in many industries.

Do you know the common mistakes made by employers that result in audits?

When working or living with a child/adolescent with an Autism Spectrum Disorder, meltdowns may occur that

The session begins with overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule

This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation

Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives.

Clinical trials are expensive, time-consuming, and labor-intensive. And in the traditional sense, study designs are inflexible.

The Bulk Of What Is Being Taught About Leadership In Universities Today Is Based On Old B.S. (“Belief Systems”).

One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements.

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

This seminar concentrates on five areas of wage and hour law:

In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel.

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical

FDA’s import and export programs are complex, detailed and undergo changes without notice to the public.

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.

The first step in catapulting your career ahead of your competitors is fully to use Microsoft Outlook.

Today's workforce is experiencing high turnover and disengaged employees.

This six-hour seminar will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission.

This course is appropriate for beginner and experienced person alike.

This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics).

This seminar will begin with a general discussion of technical writing and its role within the life sciences.

The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.

This 6-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur.

The first step in catapulting your career ahead of your competitors is fully to use Microsoft Outlook.

The session begins with overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified.

In this program, we will review the physician anti-referral laws (Stark I and II), provide an in-depth discussion of physician employment contracting, review the relevant Stark exceptions and discuss how physician compensation models can be in compliance with the Stark prohibitions.

There are two phases to this topic. The first is auditing itself. Good audits are well structured.

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls

Gain the insights and skills to know where your business stands today and where it’s heading tomorrow.

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

This seminar provides Professionals working in this area with:

This 6-hour seminar will cover the latest SAMHSA and HIPAA updates which were released in January 2018 and December of 2017 respectively

This course covers the fundamentals of medical billing, coding, and reimbursement by explaining how all of these components work together. Emphasis will be placed on the practical application of the latest industry knowledge and standards, with the goal of helping those who work with medical claims and claims data stay ahead of the game.

Statistics is a useful decision making tool in the clinical research arena.

The world is swimming in data yet raw data is mostly useless without methods to turn this data into useful and actionable information.

Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy

The Americans with Disabilities Act (ADA) prohibits discrimination against applicants and employees who are "qualified individuals with a disability."

Human error is known to be the primary cause of quality and production losses in many industries.

In 2012, the Commission adopted a package of measures on innovation in health.

Professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient.

This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.