Wednesday, August 17, 2016
9:00 – 10:00 a.m. (central time)
FDA Warning Letters are on the rise and can be issued to any entity or individual involved in developing drugs and devices. Starting with the framework of Warning Letters, this program will lay out a course to learn from others’ mistakes. Attendees can expect guidance on understanding current trends in Warning Letters, avoiding Warning Letters, and responding to a Warning Letter if necessary. Examples of key Warning Letter issues for drug and device products will be discussed including:
- Failure to establish quality procedures, corrective and preventive action plans, and complaints records.
- Failure to maintain distribution records of investigational products.
- Failure to follow the protocol for recruiting subjects and following specified inclusion criteria.
- Failure to follow cGMP.
- Inadequate reporting of adverse events to the FDA, sponsor or IRB.
- Failure to maintain documentation of finished device acceptance to ensure that each finished batch of devices meets the acceptance criteria.