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  • RF Quarterly

    RF Quarterly, October 2021: Quality and compliance

    Welcome to the fall issue of RF Quarterly in which international experts from the US, EU, and Saudi Arabia examine quality and compliance and their governing regulations, with specific focus on data integrity, quality system design and management, current good manufacturing practice (cGMP), and postmarketing activities in relation to medical devices, pharmaceuticals, and biologics.   Pragmatism, integrity, and QMS Data reliability in all formats and parts of an o...
  • RF Quarterly

    Data integrity and compliance with GxP: A pragmatic approach

    Issues related to data integrity have been in the news in recent years, often focusing on companies receiving citations from regulatory agencies regarding unreliable computer data. While the laboratory and computer data were the primary focus, data reliability in all formats and in all parts of the operation are critical to ensure products are reliable. While many also think this issue applies only to quality and operations, if the information listed in the regulatory doss...
  • RF Quarterly

    Current good manufacturing practices and quality system design

    Quality by design, or the principle of building quality into a product and testing, was introduced in 2011 as process validation guidance. Today it is codified within the Title 21 section 820. The quality management system (QMS) encompasses this principle in all areas of healthcare manufacturing – including drugs, biologics, and devices – and, with compliance, can ensure the safety and effectiveness of all manufactured products. The establishment, implementation, and maint...
  • RF Quarterly

    Medical device compliance and postmarketing activities

    This article provides an overview of medical device postmarketing requirements. These requirements include, but are not limited to, establishment registration, medical device reporting, and device tracking. Additional requirements include postmarket surveillance studies required under Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 522 and postapproval studies required at the time of approval of certain application types.   Introduction: Establishment registra...
  • RF Quarterly

    Biologics compliance

    This article discusses the phases from the product development to commercialization. Biologics are subject to 21 Code of Federal Regulations in order to meet the criteria established for safety, purity, and potency. Compliance to these regulations should be built based on a quality management system and risk management to capture changes during the product development and process validation phases and prepare a product and facility for inspection readiness. Post commercial...
  • Feature ArticlesFeature Articles

    June’s Regulatory Focus: Nutrition in health and disease management, and the gut microbiome

    This issue marks the 6th annual RAPS series on nutrition in health and disease management, and the gut microbiome, in which global experts write about food, nutrition, and dietary supplements from regulatory, trade, marketing, and legal perspectives. In keeping with the series, articles in the current issue examine US Food and Drug Administration (FDA) regulatory guidance and requirements, especially regarding dietary supplements, bioengineered products, probiotics, and CO...
  • Feature ArticlesFeature Articles

    Current status and future FDA enforcement of dietary supplements

    FDA observations for adulterated dietary supplements have remained consistent since 2010, even during 2020, when inspections were down 47% and accommodations for compliance were made because of the COVID-19 pandemic. These include requirements to establishment specifications, testing to determine if specifications are met, use of master manufacturing records, preparation of batch production records, and ensuring quality responsibilities are defined. The pandemic has also r...
  • Feature ArticlesFeature Articles

    EU IVDR compliance in a small organization

    This article presents a brief overview of the EU In Vitro Diagnostic Regulation (IVDR) requirements. It provides a user-friendly, step-by-step guide on how to comply with the regulation from first-hand experience and includes suggestions and tips for IVDR compliance through the lens of a small organization.   Understanding the changes of EU IVDR The IVDR, or Regulation 2017/746, 1 on in vitro diagnostics (IVDs) came into effect with its publication on 26 May 2017 ...
  • Feature ArticlesFeature Articles

    January’s Regulatory Focus: The impact of disruption on the global regulatory community

    Feature articles during January focused the effects of disruption on global regulatory practice. In context of the COVID-19 pandemic, authors examined expedited approval pathways for test kits in southeast Asian countries; the role of digital promotional strategies in minimizing the impact of the pandemic on advertising, promotion, and labeling; and the importance of continuing soft-skills training during remote working. Under the broader framework of disruption, a group o...
  • Feature ArticlesFeature Articles

    Transforming regulatory strategy to meet the evolving compliance landscape

    Changes in industry regulations are now viewed as one of the top three disruptive business trends facing pharmaceutical and life sciences organizations today. These same pressures are extending to the medical device market. In this article, the authors explore how perception of regulatory compliance is evolving due to a variety of driving forces. They outline the role digital transformation can play in helping pharmaceutical companies meet new regulatory compliance demands...
  • Feature ArticlesFeature Articles

    MDR, IVDR, and compliance: A guide for distributors

    Distributors must prepare for new incoming requirements under EU medical device and in vitro diagnostic device regulations. The importance of establishing an effective quality management system, drafting comprehensive contractual agreements and, if required, engaging notified bodies, has created much uncertainty for distributors. To fulfil these new requirements and maintain device supply chains, it is essential for distributors to act early, ensure sufficient in-house com...
  • Feature ArticlesFeature Articles

    Dietary supplement class actions: Recent overlap with traditional FDA enforcement

    This article provides an overview of class action lawsuits targeting the dietary supplement industry. Recent trends indicate that companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. There are also important steps companies can take to prevent these lawsuits, as well as defenses that courts seem increasingly willing to accept. By staying aware of the cl...