Search Results for Validation

Showing 1 – 16

Preparing for and Managing FDA Inspections By Sharry Arora, Bhaskar Saxena - Published 13 December 2017

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.

Categories: Features, US, FDA, Compliance, Drugs, Manufacturing

Tags: Inspections, GxP, Quality Management System, QMS, CAPA, CMC, Validation, Form 483, Quality Assurance

Pharmaceutical Cleaning Processes By John Godshalk, MSE, MBA - Published 26 July 2017

This article presents a lighthearted look at pharmaceutical industry cleaning processes, cleaning validation and cleaning verification.

Categories: Features, FDA, WHO, Drugs

Tags: Cleaning, Washing, Rinsing, Cleaning Validation

MHRA Details Common Issues in Clinical Trial Applications By Michael Mezher - Published 23 March 2017

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.

Categories: News, Europe, MHRA, Biologics and biotechnology, Clinical, Drugs

Tags: Clinical Trial Applications, Validation

Process Validation Review: How Many Ways Can You Bake a Pie? By John Godshalk - Published 08 November 2016

This article explains process validation in a fun way using pie baking as an analogy.

Categories: FDA, Drugs, Quality

Tags: Process validation

EMA Finalizes Process Validation Guidance By Michael Mezher - Published 02 May 2016

The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances.

Categories: News, Europe, EMA, ICH, Biologics and biotechnology, Manufacturing, Regulatory strategy

Tags: Process validation, process development, process evaluation, process verification

Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development By Michael Mezher - Published 26 April 2016

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.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Research and development

Tags: C-Path, biomarker validation, data sharing

Practical Guidance for Regulatory Professionals on Combination Products By Suzette Roan, JD, John Towns, PhD - Published 05 February 2016

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.

Categories: Features, Europe, US, EC, EMA, FDA, ICH, IMDRF, Combination products, Research and development, Submission and registration

Tags: Combination products, Design validation, Risk management, IMDRF

510(k) Submissions: Current Trends and Tips By Kenneth C. Maxwell II - Published 01 February 2016

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.

Categories: Features, US, CDRH, Medical Devices, Regulatory strategy, Submission and registration

Tags: 510(k), Sterilization validation, deficiencies, guidance

precisionFDA Launches to Help With NGS Assay Validation, Data Sharing By Zachary Brennan - Published 15 December 2015

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).

Categories: News, US, FDA, Biologics and biotechnology, Combination products, Compliance, Drugs, Due Diligence, Ethics, In vitro diagnostics

Tags: NGS, next-generation sequencing, NGS assay validation, precisionFDA, precision medicine

Inadequate Medical Device Validation a Common Problem; RAPS Publishes 'How-to' Resource By Zachary Brousseau - Published 16 April 2015

RAPS' Medical Device Validation Handbook, edited by Max Sherman, provides a unique compilation of expert thought and analysis of the validation and verification processes for medical devices. The book examines multiple aspects of validation, including process, design, software, equipment and cleaning validation.

Categories: HTML, Articles, Books, Under RAPS, RAPS, Compliance, Medical Devices, Quality

Tags: medical device, medical devices, medical device validation, validation, medical device process validation, verification, Sherman, book publication

Regulatory Professionals Need Better Understanding of Medical Device Validation By Zachary Brousseau - Published 16 April 2015

Author Max Sherman says regulatory professionals need a better understanding of medical device validation, and he hopes The Medical Device Validation Handbook fills a void for those who have been waiting for a comprehensive resource on the topic.

Categories: HTML, Articles, Books, Under RAPS, RAPS, Compliance, Medical Devices, Quality

Tags: medical device, medical devices, medical device validation, validation, medical device process validation, verification, Sherman, book publication

Book Excerpt: The Medical Device Validation Handbook, Chapter 1: Introduction and History By Max Sherman - Published 16 April 2015

RAPS' Medical Device Validation Handbook, edited by Max Sherman, provides a unique compilation of expert thought and analysis of the validation and verification processes for medical devices. The book examines multiple aspects of validation, including process, design, software, equipment and cleaning validation.

Categories: HTML, Articles, Books, Under RAPS, RAPS, Compliance, Medical Devices, Quality

Tags: medical device, medical devices, medical device validation, validation, medical device process validation, verification, Sherman, book, publication

EU Makes Major Update to Drug Manufacturing Guidelines By Michael Mezher - Published 03 April 2015

For the first time since 2001, the European Commission (EC) is updating its guidelines for pharmaceutical qualification and validation.

Categories: News, Europe, EC, EMA, ICH, Compliance, Distribution, Drugs, Manufacturing, Packaging, Quality, Regulatory strategy

Tags: Qualification and Validation, Good manufacturing practice, GMP

FDA Releases New Study Format Validation Rules By Alexander Gaffney, RAC - Published 19 May 2014

The US Food and Drug Administration (FDA) has released a new document intended to provide a recommended approach for submitting study data for drugs and biological products using the Standard for Exchange of Nonclinical Data (SEND) standard.

Categories: News, US, FDA, ICH, Clinical, Submission and registration

Tags: SEND, eCTD, Study Data, Clinical Data, Clinical Trials, Validation Rules

Rare Multi-Facility Warning Letter Slams Manufacturer, Says Concerns Extend to All Plants By Alexander Gaffney, RF News Editor - Published 20 March 2013

Categories: Canada, FDA

Tags: Apotex, warning letter, Latest News, cGMP, process validation, CAPA

EMA Releases Draft Guideline on Process Validation By Alexander Gaffney - Published 13 April 2012

Categories: EMA, ICH

Tags: Continuous Process Validation, Draft Guideline, Latest News, process validation