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 […]

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 […]

FDA approves first commercial product for peanut allergy prevention

The approach towards preventing peanut allergies has changed dramatically in recent years. Now the US Food and Drug Administration has approved the first commercial product, called Hello, Peanut!, to help inform the public that early peanut introduction and regular consumption can reduce the risk of peanut allergy in young children. The Hello, Peanut! introduction kit […]

FDA Breaks New Ground With First Approved Gene Therapy for Cancer

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard. “It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion. June was referring to a revolutionary cancer therapy that […]

FDA advisors give a thumbs-up to GlaxoSmithKline’s shingles vaccine

GlaxoSmithKline’s shingles Shingrix vaccine received an unanimous vote of support by a Food and Drug Administration advisory committee Wednesday on safety and effectiveness to be used in adults 50 and older. A decision by the FDA to commercialize Shingrix is expected later this year. The agency usually follows the recommendations of its advisory panels. GSK […]

New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them

The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating […]

Think like the FDA to get compliance right

If an organization in an FDA-regulated industry has to show compliance with its systems; the most effective way for it is to think the way the FDA does. This is the right approach to getting its compliance requirements right. FDA inspections can result in anything going all the way up to Warning Letters, seizures, injunctions, […]

Medical device regulatory compliance training

For any professional in the medical devices industry; training is a must. This training has to be on the regulatory aspects of the industry profession, because this is at the root of the profession. Medical devices being one of the most regulated industries, a professional in this industry is governed by a slew of regulations. […]