Health authority inspectors are like the rest of us, human. It's not an "us versus them" mentality when interacting with them as we should try to work as a partnership workin toward the same goals. Dr. Wendy Haines explains how to interact with health authorities like the FDA and EPA showing how companies overcome weaknesses in quality systems for laboratory and manufacturing practices. "Auditors and inspectors are going to look at your documentation and training records because they want to make sure people are trained on your procedures. They want to make sure you're following your procedures because that's a big no-no if you have documentation for laboratory testing or how you manufacture, and you're not following those, because that impacts the quality of the product. So they usually hit documentation, data integrity, cleaning validation." The Smart Facilities Show,podcast,Integrao,phamatech,Mack Powers,Dr. Wendy Haines,impacting human health,health,toxicology,FDA,EPA,Phd,risk analysis,biosimilar,PharmEng Technology,quality auditor,cleaning validation,QAQC,pharmaceutical,manufacturing,processes,Pfizer,COVID-19 vaccine,
