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

FDA Regulatory Compliance Advisors, Inc.™

An FDA National Expert (NE) is the highest technical position an FDA Investigator could earn during his/her career. The need for specialized technical expertise and assistance in FDA becomes more evident as complex, novel and/or sensitive in nature inspections are increasingly adopted by FDA regulated industry.

The NE provides technical assistance to other FDA Investigators during inspections and training. FDA benefits from the ability of the FDA National Expert to provide efficient and in-depth technical coverage. This translates to less chance for misinterpretation or erroneous FDA-483 observations, expediting center reviews as well as on-the-job training (OJT) for field staff.

Training performed by the FDA National Expert increases the knowledge of the field staff, allowing for the dissemination of specialized knowledge. This interaction allows for developmental growth of FDA field, Headquarter and Center staff further reinforcing succession plans of the agency.

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Firms with non-compliant histories.
Inspections of controversial scientific practices and regulatory problems.
Served as the authoritative advisor in the area of drug manufacturing.
Lead course instructor.
FDA technical review subject matter expert.
FDA special investigations subject matter expert.
Inspections of complex manufacturing sterile drugs and combinational drug products.
Inspections of large and small volume parenteral manufacturing.
Quality engineering, quality assurance and good manufacturing practices.
Computer processing, Data Integrity and Laboratory Operations.
Process Analytical Technology (PAT), Quality by Design (QbD) and Emerging Technologies.

Rebeca Rodríguez expertise falls into many areas of science and product processing including:

WHAT IS AN FDA NATIONAL EXPERT?