维萨拉公司合规高级专家Paul Daniel

Paul Daniel

维萨拉公司 合规高级专家，美国加州大学伯克利分校生物学学士学位。拥有15年制药及医疗设备行业的验证经验，执行过丰富的认证项目，包括工艺，清洁，运输，实验室设备，包装，软件，网络和计算机验证等。在应用FDA 21 CFR Part 11，210，211，和820的GMP规范，和在基于风险的GAMP指引下制定及执行药品生产验证协议和软件验证方法等方面有着丰富的实践经验。

Paul Daniel

Paul Daniel, Senior Regulatory Compliance Expert at Vaisala, has 15 years of validation experience in the pharmaceutical and medical device industries, and has worked on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network, and computer validation, and extensive practical grounding in applying the good manufacturing practices principles of the FDA 21 CFR Parts 11, 210, 211, and 820, and authoring and executing validation protocols for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines. Daniel has a bachelor’s degree in biology (with honors) from the University of California, Berkeley.