Federal Register Notice: FDA is sponsoring 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 There will also be a discussion of current compliance issues and trends and the status of the 21 CFR Part 11 draft guidance. The first workshop will be held this month, July and August 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 topics related to methodologies and implementation of quality systems, including areas such as global change control and corrective and preventative action (CAPA) investigations. The meetings will be held 6/16, East Rutherford, NJ; 7/14, San Juan, PR; 8/12, Chicago, IL. Contact Erik N. Henrikson, 301-827-9004. To view this notice, click here.
