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  • RAPS' LatestRAPS' Latest

    Medical Device Validation: What You Need to Know and Why It's Important

    Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max Sherman, the editor of RAPS’ recently published second edition of The Medical Device Validation Handbook . Unfortunately, many regulatory and quality professionals, and others involved in device compliance, lack the necessary knowledge and expertise. “People need a greater unders...
  • Feature ArticlesFeature Articles

    Preparing for and Managing FDA Inspections

    The article discusses best practices for a manufacturer to stay 'inspection ready' on a day-to-day basis with a focus on how to prepare for and successfully manage FDA inspections from start to finish. Introduction For pharmaceutical manufacturers, US Food and Drug Administration (FDA) inspections are an occasional part of being in business and perhaps a fact-of-life. While FDA is required to inspect drug manufacturing facilities every two years, the agency is also au...
  • Feature ArticlesFeature Articles

    Pharmaceutical Cleaning Processes

    This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification. Introduction I really like my new stainless steel dishwasher. It has lots of cool, blinking blue lights, many intriguing buttons and a variety of cycles. It also performs magic. I put dirty dishes in, add detergent, push the right buttons and voila! Dishes, glasses, knives and forks all come out clean about an hour later. Technology s...
  • Regulatory NewsRegulatory News

    MHRA Details Common Issues in Clinical Trial Applications

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday issued guidance detailing the most common issues it sees in clinical trial applications in an effort to help sponsors avoid unnecessary delays. According to the agency, more than half of the approximately 1,000 clinical trial applications submitted each year require additional information before they can be reviewed and approved. While MHRA typically reviews clinical trial applications for ...
  • Feature ArticlesFeature Articles

    Process Validation Review: How Many Ways Can You Bake a Pie?

    This article explains process validation in a fun way using pie baking as an analogy. If you are like me, you cook for Thanksgiving. In my family, I am expected to make several pies and my favorite is Kentucky Pie, a cross between chocolate chip and pecan pie—yummy! Every year, it turns out different. Some years, I make it with bourbon, some without and sometimes with cornmeal instead of flour. Each time it is pretty good, but different because I like to be creative. W...
  • Regulatory NewsRegulatory News

    EMA Finalizes Process Validation Guidance

    The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, which goes into effect in November 2016, covers process validation for a host of biological active ingredients, such as recombinant proteins and recombinant polypeptides, and may be applicable to other biological products such as vaccines or plasma-derived products. Process Valid...
  • Regulatory NewsRegulatory News

    Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development

    Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug Administration's (FDA) White Oak campus on Monday said. Biomarkers are biological characteristics that can be measured to give an indication of a biological process or the presence or likelihood of a disease.  They can also predict how a patient might respond to a particular inter...
  • Feature ArticlesFeature Articles

    Practical Guidance for Regulatory Professionals on Combination Products

    This article provides an overview of combination products and practical suggestions and strategies for regulatory affairs professionals when developing global submission strategies and contributing to development and design control activities. Combination Products Combining a drug, device or biological product into a new product (frequently called a "combination product") continues to be an important and growing category of therapeutic products. Approximately one-thir...
  • Feature ArticlesFeature Articles

    510(k) Submissions: Current Trends and Tips

    This article discusses current trends in the 510(k) submission process, primarily with Class II orthopedic and spinal implants, and will provide tips on maintaining a smooth and successful submission process. This past year has seen the 510(k) submission process evolve and the US Food and Drug Administration (FDA) take a more stringent stance on what submission materials will be accepted. To offset some of the technical impact of a stricter adherence to a more rigorous...
  • Regulatory NewsRegulatory News

    precisionFDA Launches to Help With NGS Assay Validation, Data Sharing

    In the spirit of sharing, the US Food and Drug Administration (FDA) on Tuesday launched precisionFDA, a new online, cloud-based platform where genomics experts from industry, academia, government and elsewhere can come together and securely share data on next-generation sequencing (NGS). The beta-launch of the site opens the door for accessing and sharing datasets, analysis pipelines, bioinformatics tools and other approaches that also could advance regulatory science. ...
  • RAPS' LatestRAPS' Latest

    Inadequate Medical Device Validation a Common Problem RAPS Publishes 'How-to' Resource

    Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device manufacturers have to interpret broad and varying definitions within FDA’s regulations and a related guidance document on the topic. Until now, there has been no comprehensive resource to help regulatory and quality professionals, and other stakeholders navigate device validatio...
  • RAPS' LatestRAPS' Latest

    Book Excerpt: The Medical Device Validation Handbook, Chapter 1: Introduction and History

    The following chapter is an excerpt taken from The Medical Device Validation Handbook . Process and Design Validation—Regulatory Concerns Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process can be validated with a high degree of assurance and approved according to established procedures, as required by 2...