A strong credit culture:

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.

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

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.

Gaps, incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible.

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.

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

This six-hour seminar will be going into great detail regarding you practice or business information technology and how it relates to

This course is appropriate for beginner and experienced person alike.

This 6-hour webinar takes the participants through HIPAA compliance from start to compliance.

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

Complaint Handling and Medical Device Reporting (MDR) are a part series on Post Market Compliance

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

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

Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients needing access to life-saving products and technologies. Government Regulatory Authorities, needing to become more efficient with their time, are looking for ways to better use their internal resources without compromising safety in products, which become marketable.

This 6-hour seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house

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.

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

Knowing what to do in employee situations can be difficult for even seasoned Managers and Supervisors, especially if a Supervisor has never had training.

We can no longer stand by and let toxic people erode patient safety, our self-esteem, and the bottom line! This webinar will help you take immediate action!

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

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

This course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system

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

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

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

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

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

This seminar provides Professionals working in this area with: