ValSource consultants have contributed key guidelines and standards that facilitated the implementation of Annex 1. Our consultants have also spoken at industry meetings on Annex 1, and led reviews of draft versions of the regulation — since the beginning of the revision process. We train your personnel on contamination control topics, risk management tools, and hands-on aseptic technique.
Basic and Advanced GMPs
Course Goal: Identify the five characteristics of a GMP-compliant product and seven essentials that contribute to achieving the desired outcomes.
Root Cause Analysis and CAPA
Course Goal: Develop the skills and techniques to conduct more effective investigations of quality incidents and identify ways to reduce the likelihood of recurrence by focusing on the root and proximal causes.
Introduction To Quality Risk Management
Course Goal: Provide a working knowledge of the concepts and tools used in managing risk with applications to pharma and biopharma activities.
Improving GMP Performance
Course Goal: Explore ways of moving from the traditional use of training to where learning, knowledge management, and process understanding contribute to better worker performance, compliant outcomes, and high-quality, pharmaceutical products & medical devices.
Seven Essentials of GMP
Course Goal: Examine each of the seven essentials of GMP, the rationales behind them, where firms have failed, and ways to strengthen quality and compliance.
Critical Thinking in a GXP Environment
Course Goal: Identify what critical thinking is and ways to analyze a statement for its intent, conclusion, and the quality of evidence presented.
Understand Annex 1:
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