The receipt of a FDA 483 at the conclusion of a facility inspection is a serious message to the company about the concerns the FDA has about your product quality, organizational control, complaint handling, or management oversight and the violation of the Food, Drug & Cosmetic Act. Remember, the sky is not falling but a company needs to focus on the importance of the warning and to understand the larger message the agency is sending.
Learn the most frequent deficiencies cited in FDA 483s as well as the common pitfalls when addressing compliance remediation issues. This webinar will focus on the most effective methods to draft a response and develop corrective actions, in order to successfully allay FDA concerns and avert the issuance of a Warning Letter.
Our speaker, Judith Meritz has been specializing in strategic planning and compliance mediation internationally for Life Science companies more than 30 years.