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

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

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.

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.

Professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs

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.

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

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

This seminar concentrates on five areas of wage and hour law: paying exempt employees, calculating gross wages under the FLSA, deducting from an employee's wages, the nuts and bolts of physically paying employees and changing payroll frequencies.

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

There are two phases to this topic.

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

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.

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

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

Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product.

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

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.

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

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

This seminar provides Professionals working in this area with:

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

The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan.

A strong credit culture:

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.

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