Tougher Import Rules for FDA Imports in 2019

Course “Tougher Import Rules for FDA Imports in 2019” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Background: FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that […]

Seminar on HIPAA 2019 | HIPAA Security Risk Assessment | What’s new?

Description: This two-day seminar will get into the fine details of what we need to do and how to do it. We will go point by point through the entire HIPAA Security Rule and uncover simple methods to comply and create policy. The primary goal is to ensure everyone is well educated on what is […]

Virtual Seminar on HIPAA Training for Compliance Officer

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. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. Areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors […]

Seminar on Validation and Troubleshooting of Pharmaceutical Water Systems

 Description: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The […]

Virtual Seminar on 21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

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. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability. FDA’s […]

Tougher Import Rules for FDA Imports in 2019

  Course “Tougher Import Rules for FDA Imports in 2019” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Description: FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence […]

Seminar on Biostatistics for the Non-Statistician

Why should you attend: Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics. Many statistical softwares are now available […]

How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Course “How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT […]

High degree of Assurance in its Manufacturing Process to Justify Commercial Distribution of the Product

Focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance.