This course will focus on Regulatory Inspections and Quality Audits. It will cover Health Authority inspections as well as internal Quality Audits and also managing corrective action plans that can result from audits.
Regulatory Inspections and Quality Audits are something every Pharmaceutical and Biotech company should be familiar with. These can be inspections conducted by Health Authorities, such as the US Food and Drug Administration, or they can be audits the company does internally to either prepare for a Health Authority inspection, or just to ensure proper operations at their manufacturing sites. This course will cover the basics for both of these types of inspections and audits, including giving companies basics to be prepared for both the inspection/audit and the outcomes.
Principal Consultant, Lessem Regulatory Consulting LLC
Martin A. Lessem, J.D. is a professional with 17 years of experience in Pharmaceuticals. In the past 12 years he has been heavily involved with Regulatory Risk Management and worked on many of the larger industry programs. He has worked at large companies, small companies, innovator companies, and generic companies and has worked in risk management in all those settings. Currently, he is a consultant to Pharmaceutical companies on Regulatory Strategy and Risk Management.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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