In order to ensure the safety, efficacy and quality of therapeutic products, FDA is responsible for conducting both pre- and post-approval inspections to enforce compliance with applicable regulations and quality standards. The instrument with which FDA officially notifies firms of objectionable findings and potential violations is the form FDA 483 (483), which was put in place to assure that firms receive proper notice prior to any actions undertaken against them by the agency. This legislation also requires that firms receive official written notice of inspection prior to the conduct of any such enforcement activities.
While it is clear that the purpose of the 483 is to list and document objectionable conditions disclosed during FDA inspections, it also serves to assist companies in the remediation of their nonconformities. In 2009, new and enhanced federal enforcement strategies were implemented by Congress requiring that firms submit all post-inspection 483 responses to FDA within 15 working days of receipt. Failure to comply with this mandate results in the issuance of a Warning Letter.
Upon completion of the course, you will have a full and balanced understanding of the notification of findings (483) process, and how to effectively prepare a sound and strategic response toward a favorable outcome with minimal risks.
During this interactive session, we will discuss:
This course will be valuable to anyone engaged in the development, manufacturing, sale or distribution of FDA-regulated healthcare products. Additionally, this course will provide a good primer for senior management or general staff who need to be aware of such inspectional notifications and their implications.
Richard A. Angelo, PhD, is Principal Scientist, Clinical Research, for Cardinal Health Regulatory Sciences. He has more than 28 years of product development experience in the pharmaceutical, biologic and medical device industries in operational, senior operational, executive leadership and senior consultant roles. Dr. Angelo is currently responsible for clinical research product development services in areas such as clinical program planning; regulatory strategies toward commercialization; Phase 1 to 4 clinical study design, oversight and management; vendor qualification and management; investigator site qualification and management; regulatory, clinical and quality compliance management; regulatory agent services; and management of regulatory submissions.
His industry tenure includes leadership positions in publicly traded US pharmaceutical corporations as well as full-service contract research organizations. He has led regional, national and international multidisciplinary clinical development teams in various therapeutic areas, including infectious diseases, oncology, analgesia and allergy. Dr. Angelo’s expertise helps companies ensure compliance with FDA regulations, harmonized international regulations, industry guidance documents, Good Clinical Practices, Good Clinical Laboratory Practices, Good Pharmacovigilance Practices, clinical study protocols and applicable standard operating procedures pertaining to development and commercialization of drugs, biologics and medical devices. Dr. Angelo was the principal author of chapter 16, “Medical Device Compliance and Postmarketing Activities,” in Fundamentals of US Regulatory Affairs, Seventh Edition, a Regulatory Affairs Professionals Society (RAPS) publication.