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Zdrowie i gospodarka · 3.06.2003

Drug Manufacturing Inspections; Public Workshops

The Food and Drug Administration (FDA) is announcing a series of public workshops to discuss current good manufacturing practice (CGMP) issues, including quality subsystems, areas of change control, and quality management. There will also be a discussion of current compliance issues and trends and the status of the part 11 (21 CFR part 11) draft guidance. The first workshop will be held in June 2003, then repeated in July 2003 and August 2003 at different locations to enable as many people to attend as possible. Held in collaboration with the Consumer Healthcare Products Association (CHPA), the workshops are intended to update participants with respect to issues involving CGMP compliance. Participants will also hear from FDA and industry speakers on specific topics related to methodologies and implementation of quality systems including areas such as global change control and corrective action preventative action (CAPA) investigations.

Source: Federal Register — Food and Drug AdministrationOpen original release →