FDA

  Quality by Design: A Challenge for the Pharma Industry   FDA Warning Letter Data (2010)   FDA QSIT Presentation   FDA CAPA Presentation   FDA Management Review Presentation   FDA Design Control Presentation   FDA cGMP for Combination Products Practical Issues

Medical Devices

  Barriers to Medical Device Quality (FDA 2011)   FDA Issues Rule to Regulate Medical Device Data Systems   GHTF Proposed CAPA Guidance for Medical Device Manufacturers   The Commonalities Between Risk, Verification & Validation   Challenges of International Medical Device Labeling   How to Kick Start your CAPA process   Fitting Human Factors in the Product Development Process   Standard Work for Problem Solving

Management Articles

  The Value of a Compliant, Effective and Efficient CAPA System   How to Prepare for an FDA Inspection   The 5 "W"s of Quality Agreements   Designing a Winning CAPA System   The Secrets of Team Facilitation   What's Wrong? Why Do We Have Repeat Investigations?   Qualification and Validation of Middleware and Service-Oriented Architectures

Pharmaceuticals

  BioPharma Automation: Transformation through Training   MHRA New Guidance for Pharmaceuticals   How to Comply with ICH Q7   Compliance Guidance for Drug Manufacturing Inspection   Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations

Emerging Manufacturing Markets

  FDA Presentation on cGMPs to China

Government

  S. 3409 Kennedy-Grassley Bill

Webinars

Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects

CAPA for Life Sciences

Overview: Quality System Regulation (QSR)

Problem Solving in the Lean Supply Chain

Risk Management Panel

Six Steps to Better Device Labeling

The Application of Lean Management Systems to Life Sciences

Tools and Reports

  A Status of Quality in Life Sciences (2011 Report)

  Technical Writing - Style Guide

  CAPA System Implementation Map