The FDA Group’s CEO, Nick Capman, sits down with George Toscano, President & CEO of Toscano Consulting Group, to explore recent FDA enforcement trends and the nuances of the FDA inspection process, especially in light of the COVID-19 pandemic's impact on the industry.

Discussion points include:

» George's extensive background in the pharmaceutical, biologics, and medical device industries, highlighting his transition from an analytical development chemist to a consultant specializing in quality and regulatory work.

» The emergence of new companies in the pharmaceutical space during the COVID-19 pandemic, particularly those producing hand sanitizers, and the challenges they faced with Good Manufacturing Practices (GMP).

» The FDA's increased scrutiny on the presence of diethylene glycol and ethylene glycol in components, reflecting on historical issues and the importance of stringent testing for these contaminants.

» The problem of inadequate authority within quality units, especially in Over-The-Counter (OTC) manufacturers, leading to compliance issues and insufficient testing for harmful impurities.

» A shift in the FDA's focus towards ophthalmic products due to recent contamination issues, and the anticipation of this becoming a new wave of enforcement.

» The significant reduction in on-site FDA inspections during the pandemic, the transition to remote evaluations and document requests, and the gradual return to on-site inspections with continued use of remote tools.

» The concept of FDA "waves" of focus, with a recent pre-COVID wave on OTC manufacturers, and the potential for new waves targeting different areas such as ophthalmic products.

» The perennial issues cited by the FDA, such as the failure to conduct adequate investigations and the lack of or failure to follow written procedures, which are expected to continue being focal points in FDA observations.

Mr. Toscano is an experienced consultant with over 25 years in the industry, specializing in international compliance, Data Integrity, and quality systems. He has successfully managed projects addressing FDA enforcement actions, such as 483 responses, Warning Letters, and Consent Decrees. His expertise extends to laboratory and manufacturing investigations, CAPA, change control, and stability programs. He has also led analytical R&D labs, overseeing product development and regulatory submissions, including ANDA, NDA, and 505(b)2 applications. Recently, he spearheaded a multi-year expansion and remediation for a biologics manufacturer under a consent decree. His comprehensive knowledge in quality assurance, data integrity, validation, and cGMP training has been pivotal in helping clients develop and fix quality systems to meet FDA standards.

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