eCTD Submissions of IND/NDA to the US FDA, EU and Canada

It will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. 

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

Non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety.

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 […]

Cleaning and Sanitation Training for Food Processors

We will cover several topics of value to food manufacturing sanitation team members. We will begin with a conceptual understanding of cleaning vs. sanitation. We will then review proper cleaning techniques to ensure microbial and allergen residue removal. Attendees will learn about the chemicals used in industrial cleaning and sanitation and how to protect themselves […]

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 […]