Podcast 7: Assuring Excellence! Inside the Role of QA Director in Contract Research Organization

Podcast # 7
Neeku Mahdavian interviewed Hubert Lin, the Director of Quality Assurance at Emery Pharma. In their conversation, Hubert discussed the role of a Quality Assurance Director in a contract research laboratory, emphasizing the importance of adhering to standard operating procedures and maintaining data integrity. He also highlighted the significance of a robust quality management system and stressed the need for effective communication with clients for successful collaboration. Additionally, Hubert pointed out the necessity for CROs to stay updated on regulatory changes, particularly from organizations like USP, FDA and EMA. Training and certifications, especially in critical areas like data integrity, were underscored as essential for QA professionals. Hubert recommended relevant courses for those entering QA, emphasizing the importance of understanding and applying rules and regulations. The overall theme emphasized the proactive approach of training and prevention to ensure smooth operations, with a particular focus on securing data from potential threats.
About Emery Pharma:
Emery Pharma is deeply committed to advancing public health and exclusively focuses on projects that enhance the well-being of both individuals and the environment. As a comprehensive contract research laboratory, Emery Pharma provides extensive support across the entire spectrum of pharmaceutical development, covering small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more.
Emery Pharma's array of premium services includes analytical and bioanalytical solutions, microbiology and cell biology services, drug and impurity characterization, and comprehensive R&D with cGMP/GLP support. The Emery Pharma team excels in customizing innovative solutions tailored to the unique requirements of each client. They seamlessly oversee the entire process, from initial drug discovery to thorough data analysis and insights generation. Their expertise allows them to tackle scientific challenges proactively, ensuring clients avoid unnecessary setbacks.
Emery Pharma's accomplished chemists and biologists harness state-of-the-art technology, encompassing cutting-edge tools such as high-resolution mass spectrometry (Orbitrap), triple quad LC-MS/MS, GC-MS, preparative HPLC, and 400 MHz multinuclear NMR.
For further details, please don't hesitate to reach out to Emery Pharma at [e-mail] or explore their website at:
emerypharma.com/