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The two courses offered as part of the 2016 Data Integrity Workshop Course Series on Dec. 9 will delve into the regulatory and scientific elements of investigating microbial data deviations and CMC sections in drug applications. Courses will explore the following topics: Investigating Microbial Data Deviations (Dec. 9) Existing FDA guidance addresses investigation of Out of Specification test results, but doesn't address data deviations encountered in microbiological testing. In this course, you'll explore the regulatory and scientific elements that must be taken into consideration when investigating microbiological data deviations. The elements and benefits of flowcharts, checklists and process flow diagrams, as they apply to the investigation process, will be discussed to showcase a practical approach to designing and conducting investigations into microbiological test data. CMC Regulatory Requirements in Drug Applications (Dec. 9) This course will prepare individuals in a regulatory affairs role to better understand the requirements of a CMC section for multiple drug applications, including investigational new drug applications, new drug applications, abbreviated new drug applications, drug master files and post-approval change supplements. There will also be a brief discussion about complying with current Good Manufacturing Practice.
PDA is accredited by ACPE and offers continuing education for professional engineers. |
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