Inspection Essentials 2021 - FDA Inspection Essentials in 2021

The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control.
Working in a highly regulated industry, we know our firms need to be “inspection-ready” at all times. This is not only to maintain a good rapport with the Regulators, but also as a commitment to quality for our customers, the patients who use our products.
•Module 2: 12:00pm ET-1:00pm ET
•Preparing for FDA audits
•Do’s and Don’ts
Speaker:
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems