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Compliance Architects^® now offers free online training on select topics of importance to FDA-regulated industry. We are pleased to use web-based technologies to help you understand the complexities of FDA regulation and enforcement and are pleased to offer these programs free of charge to eligible industry professionals. We believe you will find the information in these training sessions important, relevant, and timely.

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 full business contact information. This information will be verified by a representative of Compliance Architects^®. 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 ABSTRACT

Link to Course Materials

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? Over the last year, FDA has made clear that it is taking a much more aggressive approach to FDA enforcement, and as a result, press coverage of significant FDA inspections and enforcement action are occurring on almost a daily basis. It has never been more important for companies to "get it right" before the FDA walks in the door. This means that 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 Webinar will 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.

Click this link for a course preview
(coming soon).

Click this link to access the course materials with the password you have been sent.


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Compliance Architects^®: Innovative, business-focused compliance for FDA-regulated industry.