| Description |
The conference will offer a comprehensive look at all aspects of inspections, including preparation of an inspection plan and personal training, the inspection process and responses to FDA after the inspection. With interactive discussion, case studies and real-life experiences, this conference will provide valuable take-home knowledge for regulatory affairs professionals. Additionally, this conference will provide a background and understanding of the role of the FDA and its administrative and enforcement powers. It will take the participant step-by-step through the entire inspection process and describe various types of inspections, i.e. pre-approval inspections (PAI), routine GMP inspections, quality systems inspections techniques (QSIT) applied to device companies and system-based inspections program applied to drug companies.
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