FDA Inspection’s 2020 - 7 secrets about Managing Your FDA Inspection’s 483 Observations Webinar

FDA’s is authorized to inspect regulated facilities and point out problems. How a firm responds to the inspection and how it plans to correct the problems has a significant impact on how FDA treats the firm after an inspection.
FDA inspections look for noncompliance with applicable manufacturing regulations. During the inspection the FDA investigator makes a “list of observations” that gives examples of violations.
Inspection procedure for identifying noncompliant practices
Discussions during the inspection with the FDA
Speaker:
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He conducted domestic and foreign inspections.