TM

“Combining science with regulatory knowledge for optimized systemic solutions.” ™ 

FDA Regulatory Compliance Advisors, Inc.

  • How are FDA Investigators trained to conduct inspections?
  • How do they decide where to focus their inspections?
  • What criteria do Investigators use to decide what should go on a 483?
  • How do Investigators decide if they should recommend a regulatory action for their inspections?
  • What role does Critical Thinking play in inspectional and regulatory decisions? 

TM

As a former FDA National Expert Investigator / FDA National Lead Instructor  responsible for training FDA Investigators, provide guidance and recommend FDA enforcement actions conmensurate with inspectional findings, Rebeca Rodríguez, President FDA-RCA™, is uniquely qualified to answer these questions and train your staff to Audit like an FDA Auditor.  

But...

Learning the answers to these questions and others can help companies in many ways:


  • Increase inspection readiness to prevent adverse inspectional findings,
  • Enhance internal audits to more accurately target likely FDA-focus areas,
  • Effectively understand how to address inspectional findings to prevent escalation. 

FDA Investigators are trained to systematically identify significant GMP deficiencies and adverse trends that may be indicators that one or more of the firm's systems are out of control.


More importantly, FDA Investigators are also trained to make recommendations for follow-up activities and regulatory actions. 

Audit Like An ​

FDA Auditor

"Avoid FDA-483s and WLs"

​Earn an FDA-RCA™ certification to reach professional development goals and gain an advantage in your career. 

Get Certified Now

Benefits...