Consideration of ICH Guideline, Industry Norms Necessary for Compliant Clinical Quality Assurance Plan

Teresa Gorecki |

Savvy companies already understand that Quality Assurance (QA) must be integrated into the clinical development system, not relegated to an afterthought of audits and quality control (QC) checks. But exactly how should this be accomplished? Review of current... Read more

Investigations, Analyses and Conclusions: Finalizing Well-Written, Inspection-Ready Documents

Jack Garvey |

Well-drafted, easy-to-understand quality records are crucial to helping pharmaceutical and medical device manufacturers navigate FDA inspection obstacles. The FDA relies heavily on information presented in inspection-implicated documents to determine whether a manufacturing operation is compliant with FDA's requirements... Read more

Dedicated, Integrated Quality Assurance Systems Critical to Successful Clinical Trials

Teresa Gorecki |

The notion that the role of Quality Assurance (QA) in clinical development should be relegated to reviews, audits and quality control (QC) checks is an antiquated one that could well run medical product developers afoul of FDA and... Read more