Training Doyens

OVERVIEW In this webinar you will learn about the types of FDA inspections , preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and responding to 483s and FDA warning letter. How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them. WHY SHOULD YOU ATTEND FDA is required to conduct an inspection every two years. A company that is prepared for FDA audits is less likely to receive 483’s than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving an FDA warning letter. AREAS COVERED Personnel preparation Procedure to follow during FDA audits - what to do/ what not to do Facility requirements to s...

OVERVIEW In this webinar you will learn about the types of FDA inspections , preparations such as assigning personnel to specific tasks for the FDA inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and techniques for responding to 483s and warning letters. How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them. WHY SHOULD YOU ATTEND FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483’s than a disorganized company.  If a 483 is received knowing how to respond will lessen chances of receiving an FDA warning letter. AREAS COVERED Personnel preparation Procedure to follow during FDA audits -what to do/ what not to do Facility ...