FDA Regulatory Compliance Advisors, Inc.™
Former FDA National Expert Investigator
Former FDA National Lead Instructor
Ms. Rodríguez led the team that conducted two of thefirst PAT pre-operationalvisits that resulted in the approval of the first PAT Comparability Protocol that proposed changes in the manufacture and control of both the active pharmaceutical ingredient (manufactured in Germany) and the drug product (manufactured in the US).
Ms. Rodríguez also led an FDA/EMA team on a foreign pre-approval inspection of a QbD NDA that identified and established a process control strategy using PAT, multivariate modeling, SPC and risk management tools.
In addition, she led several FDA/EMA teams on CM (Continuous Manufacturing) pre-operational visits and pre-approval inspections. These team inspections
used FDA’s integrated approach that includes Reviewers and Compliance Officers on inspections. Ms. Rodríguez has also demonstrated her specialized
knowledge and support of FDA’s QbD and PAT initiatives by providing numerous presentations and frequent technical assistance to FDA personnel, Academia and Industry.
In July of 2004, Ms. Rodríguez was among the first to become certified as Level II Drug Investigator and as
Level II Drug Investigator Certification Performance Auditor under the newly implemented Drug Certification program. She was also among the first
five Investigators certified at Level III (Pharmaceutical Inspectorate). Ms. Rodríguez was an Instructor in FDA training courses such as pharmaceutical Inspectorate, Process Validation, Basic Drug School, API (Active Pharmaceutical Ingredients) Manufacturing, International Inspections, Pre-Approval Inspections, Industrial Sterilization, and Computer-Aided Inspections. Since 2013, she was the Lead Instructor in one of the two main Drug Investigator Training Courses, DG 230. This 2-week course comprised Systematic Drug Inspection elements of drug manufacturing principles, Process Validation and inspectional/auditing techniques.
Ms. Rodríguez was also responsible for providing on-the-job training to ORA Investigators and Analysts. CDER personnel also received on-the-job training from Ms. Rodríguez. In addition to training FDA staff, Ms. Rodríguez has regularly provided drug GMP training
to Industry and regulatory bodies from foreign countries. Ms. Rodríguez has extensive experience providing advice and serving as liaison to international organizations such as WHO, regulated industries, other Federal agencies and executive managers within FDA.
Ms. Rodríguez work in the international arena included activities that supported FDA’s leveraging efforts. For instance, Ms. Rodríguez was ORA’s field expert working towards FDA’s acceptance in
PIC/S (Pharmaceutical Inspection Convention Scheme). Ms. Rodríguez also worked for three years with representatives of regulatory bodies from US, Canada and Latin American countries in drug GMP harmonization activities promoted by PAHO/WHO.
In June of 2004, Ms. Rodríguez was the only ORA representative in outreach meetings held in South Africa and India under PEPFAR (the President’s
Emergency Plan for AIDS Relief). This high-profile mission was assigned by the Department of Health and Human Services, and was led by the Assistant to
the HHS Secretary. The US Embassies in both countries hosted the US HHS Team and participated in the meetings with local government authorities and drug manufacturers. Ms. Rodríguez’ role in these meetings was to explain FDA’s inspectional processto firm’s interested in getting FDA’s expedited approval for Anti-Retroviral drugs intended for the treatment of AIDS in the countries listed under PEPFAR.
During her FDA career Ms. Rodríguez regularly wrote and/or evaluated regulatory and policy documents, such as Compliance Programs, CDER’s Q&A
documents, and Guidances to Industry on OOS Investigations, PAT (Process Analytical Technologies), Process Validation, Contract Manufacturing, etc. In addition, she prepared and delivered briefings, technical and scientific papers, specialized and complex training, and official reports and decision memos.
Ms. Rodríguez is the recipient of numerous prestigious awards for outstanding performance.
Rebeca Rodríguez is an Industry Advisor and President of FDA Regulatory Compliance Advisors, Inc.™ She worked for 27 years at the Food and Drug Administration (FDA) as Investigator. For the last 13 years of her career Rebeca worked as a National Expert Drug Investigatorreporting to FDA ORA Headquarters in Rockville, MD.
Ms. Rodríguez received her degree in Chemistry from the University of Puerto Rico, Río Piedras Campus.
Ms. Rodríguez is certified by the ASQ (American Society for Quality) as a Quality Engineer (CQE) since 1991; and has specialized knowledge in the principles and tools that have been used to support Quality by Design (QbD) and Statistical Process Control (SPC) in the regulated industry.
During her FDA career Ms. Rodríguez has accumulated expertise in areas such as complex biotechnology, drug and medical device inspections, both domestically and internationally. Her professional experience includes planning, conducting and directing highly technical, complex and multi-
faceted inspections and in-depth investigations, including regulatory inspections and criminal
investigations of data integrity cases.
Ms. Rodríguez was one of the first four ORA Investigators that were certified as members of the PAT (Process Analytical Technologies) Review and Inspection Team, and more recently was the Senior
ORA representative to the ETT (Emerging Technologies Team).
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