TM

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

FDA Regulatory Compliance Advisors, Inc.

  • Rebeca. I hope this message reaches you before you depart from FDA. It has been such an honor to know and learn from you – you will be missed!
  • Thanks Rebeca for your support in responding to questions and Compliance Programs.  I learned a lot from you during my audit and have been mindful of the things I learned. You are just a one of a kind asset!
  • It has been such an honor to know and learn from you – you will be missed at FDA!

- FDA Investigator

  • Thanks again for your thoughtful advice coupled with real life examples of drug inspection experiences. These were the “gems”that gave students opportunities to think outside the box.

- FDA Investigator

•    GMP training for Pharmaceutical Dosage Form, Active Pharmaceutical 
     Ingredient (API) and Biotechnology Industries

•    Representative Sampling Techniques

•    Sterility and Media Fills

•    FDA Auditing techniques:
     o    Parenterals
     o    Biotech, API, and Dosage Form Manufacturing Processes
     o    Aseptic Manufacturing Processes 

•    Critical Thinking: An FDA Regulatory Perspective for Investigative Writing

•    Do’s and Don’ts:
     o    Root Cause Analysis
     o    Corrective and Preventive Action Plans (CAPA)

•    GMPs from an ICH Q8, Q9 and Q10 perspective

•    FDA Readiness for Pharmaceutical and Biotechnology Industries

•    An FDA Perspective of Cleaning Validation

•    FDA Approach to Good Outsourcing Management (GOM)

•    FDA Auditing techniques of Data Integrity, Computer System Validation             (CSV) and Part 11

•    Developing an effective Failure Investigation and CAPA system

- FDA Investigator

  • SAMPLING

  • MEDIA FILLS

  • ASEPTIC API
    BIOTECH

  • ROOT CAUSE
    ANALYSIS

  • CAPA

  • PROCESS
    VALIDATION

  • FDA 
    READINESS

  • DATA 
    INTEGRITY​

  • CSV/PART 11

  • ​FDA AUDITING
    TECHNIQUES

  • Thank you very much Rebeca for all your dedication, perseverance and expertise in providing your invaluable wisdom in teaching, guidance and insight in the development and leadership of drug school courses throughout the 10+ years as a CAG member. 
  • Rebeca. FDA will miss you!!! You are our greatest teacher and we appreciate you transferring your knowledge to us. It was an honor and a pleasure to meet you!

- FDA Investigator

- FDA Investigator

Testimonials:

TRAINING AREAS

- FDA Investigator

  • Rebeca, FDA will miss you!!! You are our greatest teacher and we appreciate you transferring your knowledge to us. It was an honor and a pleasure to meet you!
  • Dear Rebeca. Thank you again for making this a wonderful training experience. We barely know each other but again, you made a huge impression... You will be missed.

- FDA Investigator

TRAINING SERVICES


Regulatory compliance trainings are developed and presented by Ms. Rebeca Rodríguez, Industry Advisor and Former FDA National Expert Investigator / Former FDA National Lead Instructor. Ms. Rodríguez was an FDA 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.

Learn now from this outstanding presenter offering the most cutting-edge regulatory enhanced comprehension available. Courses are provided on-site and are from one to five days in length. Courses include exercise and workshop sessions for enhanced comprehension of the training material. 


Our Main Training Program Areas:

- FDA Investigator