EduQuest Advisory 4 Pillars Of Qsr ComplianceEduQuest, Inc.
FDA believes four core quality subsystems should be the foundation of every firm’s quality efforts. This Advisory, written by Denise Dion, a former FDA investigator and now a Vice President of EduQuest, focuses on what you need to know about Management Controls; Design Controls;Corrective and Preventive Actions (CAPA Systems); and Production and Process Controls (P&PC)-- plus the very important inter-linkages of each.
Hot Potato Of Responsibility Edu Quest AdvisoryEduQuest, Inc.
EduQuest Advisory for "how to manage outsourcing and not get burned" written by Martin Browning, former FDA investigator and the co-founder and president of EduQuest.
FDA Data Integrity: Misconceptions of 21 CFR Part 11 EduQuest, Inc.
Martin Browning, co-author of FDA's 21 CFR Part 11 regulation for electronic records and signatures, explains FDA's expectations for data integrity and common industry misconceptions about how to comply with the rule.
9 Common Validation Errors EduQuest AdvisoryEduQuest, Inc.
The most common computer system validation deficiencies and the most vulnerable documents -- based on lessons learned from 1,720 observations in a single validation project. Ten-page Advisory from EduQuest, a global team of FDA compliance experts.
EduQuest Advisory 4 Pillars Of Qsr ComplianceEduQuest, Inc.
FDA believes four core quality subsystems should be the foundation of every firm’s quality efforts. This Advisory, written by Denise Dion, a former FDA investigator and now a Vice President of EduQuest, focuses on what you need to know about Management Controls; Design Controls;Corrective and Preventive Actions (CAPA Systems); and Production and Process Controls (P&PC)-- plus the very important inter-linkages of each.
Hot Potato Of Responsibility Edu Quest AdvisoryEduQuest, Inc.
EduQuest Advisory for "how to manage outsourcing and not get burned" written by Martin Browning, former FDA investigator and the co-founder and president of EduQuest.
FDA Data Integrity: Misconceptions of 21 CFR Part 11 EduQuest, Inc.
Martin Browning, co-author of FDA's 21 CFR Part 11 regulation for electronic records and signatures, explains FDA's expectations for data integrity and common industry misconceptions about how to comply with the rule.
9 Common Validation Errors EduQuest AdvisoryEduQuest, Inc.
The most common computer system validation deficiencies and the most vulnerable documents -- based on lessons learned from 1,720 observations in a single validation project. Ten-page Advisory from EduQuest, a global team of FDA compliance experts.
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