The FDA Drug Development Process

This webinar provides an overview of the FDA’s Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process – the GLP, GMP and GCP regulations. This webinar is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on […]

Applied Statistics for FDA Process Validation

Course “Applied Statistics for FDA Process Validation” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, “”…the collection and evaluation of data, from the process design stage through commercial production..” The guidance further delineates the […]

What are the FDA’s Process Validation requirements?

Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the […]

Applied Statistics for FDA Process Validation

Course “Applied Statistics for FDA Process Validation” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, “”…the collection and evaluation of data, from the process design stage through commercial production..” The guidance further delineates the […]

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 […]

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 […]

How the FDA interprets advertising and promotion in principle and in fact

If you go “off label” with advertising and promotion, FDA’s hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer […]