Compliance Architects® now offers free online training on select topics of importance to FDA-regulated industry.
Free online training topics are available to individuals and groups employed by companies directly regulated by the US Food and Drug Administration.
In order to access these free training sessions, we require your business contact information. Upon verification of information provided, and eligibility, you will receive an email at your company email address with the password to access the training materials.
We hope you find these materials helpful in your quest for improved compliance outcomes!
COURSE TITLE: INSPECTION READINESS FOR A MORE AGGRESSIVE FDA
It is the goal of every company during an FDA Inspection to have no FDA 483 observations at the end of the inspection. However, is this realistic, particularly in light of the FDA’s new, more aggressive enforcement approach? For a number of years, FDA has made clear that it is taking a much more aggressive approach to FDA enforcement, and as a result, significant FDA inspections and enforcement action are occurring much more frequently than in the past. It has never been more important for companies to “get it right” before the FDA walks in the door. As a result, your Quality organization must be ready at all times to:
- Demonstrate and explain the process and procedural controls used in your operation;
- Respond to detailed critique of product failures, customer complaints, and internal investigation conduct;
- Explain many aspects of your quality system decision rationales; and
- Demonstrate a state of control, both in general, and by product.
Preparing for an FDA inspection requires robust systems, well constructed documents, proper training, appropriate computer-based tools, and lots of preparation. This webinarwill provide you with a “Readiness Master Plan” that outlines the essential elements for inspection readiness, and will review techniques for assuring your controls and records are ready for review.