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About the President and Founder


Ms. Rodriguez is the founder of Monarch Quality Systems Solutions and has over 34 years of extensive experience working in the Medical Device, Pharmaceutical, Biologics, Compound Pharmacy, OTC, and OTC Cosmetics industries. She has worked both within the industry and as a Principal Consultant to the industry. For over 20 years she held multiple positions as Director of Quality and Regulatory Compliance, and Senior Manager of Quality and Regulatory Affairs. In addition, she has more than 13 years as an independent consultant advising to industry leaders.

Ms. Rodriguez is the founder of Monarch Quality Systems Solutions and has over 34 years of extensive experience working in the Medical Device, Pharmaceutical, Biologics, Compound Pharmacy, OTC, and OTC Cosmetics industries. She has worked both within the industry and as a Principal Consultant to the industry. For over 20 years she held multiple positions as Director of Quality and Regulatory Compliance, and Senior Manager of Quality and Regulatory Affairs. In addition, she has more than 13 years as an independent consultant advising to industry leaders.Ms. Rodriguez’s primary focus is to effectively and efficiently assist Medical Device, Pharmaceutical, Biologics, Compound Pharmacy, OTC, and OTC cosmetics companies in identifying compliance gaps within their respective quality systems and then remediating those issues into meeting all aspects of US and Global regulatory compliance. She develops solutions that include; process mapping, interim controls, corrective actions, coaching, and training for ultimately obtaining clearance from regulatory bodies.

She acts as a key contributor to Global Leadership Teams and helps to develop organizational strategies and structures. She creates and implements compliant: Deviation Management Systems, Failure Investigation Processes, CAPA Systems, Immediate Corrections, Interim Controls, Retrospective Reviews, Root Cause Analysis, Document Management, Production and Process Controls with Validation, Out of Specification (O.O.S.) Procedures, R&D Support Tools, Pilot Batch Testing, Stability Testing, Analytical Test Methods, Document Control, Supplier Quality Assurance, Quality Engineering, Risk Management/hazard analysis, Electronic Records/Electronic Signatures and Documentation Systems, as well as HIPAA requirements, as well as Lean Manufacturing and Six-sigma.

Ms. Rodriguez has implemented several Audit programs, and has performed internal and external GMP/ISO and clinical audits of ongoing clinical trials in progress across the organization (for both US and EU trials).  As well as, completed an objective assessment of where the client’s documentation was in with respect to processes and systems and compliance to US FDA (medical device, Pharmaceutical, Biologics and Combination products), EU MDD/IMDD, and EMEA, ISO13485, ISO14971, JPAL, MDD/IMDD, ISO14155 (2011) requirements in order to provide and address any gaps in order to provide recommendations and improvement plans.

She applies GMPs and Quality System standards to IVDs, Medical Devices, Biologics and Sterile Packaging. She has specific experience in controlled aseptic environments, sterilization validation, cleaning validation, microbiological quality issues. She also managed programs for internal and supplier audits and served as a Lead Auditor for all critical and technical areas and Suppliers. She implemented Lean/6 Sigma improvement methods yielding significant savings, for several companies worldwide. 

She has trained thousands of Pharmaceutical, Biologics and Medical Device Professionals as a Educational Course Director for over 15 years. The courses included: 

  1. How to Implement an effective Root Cause Analysis and CAPA Program
  2. Effective Quality Assurance Auditing for FDA Regulated Industries
  3. Process Validation for Medical Devices and IVDs
  4. Design Control for Medical Devices
  5. Field Actions and Their Management – Recalls, Product Recovery and Safety Alerts
  6. Implementing Risk Management Principles and Activities within a Quality Management System
  7. Overview of FDA Regulatory Compliance for Medical Devices and Combination Products
  8. How to Effectively Prepare for FDA Inspections
  9. Computer Systems Validation & Part 11 compliance
  10. How to Develop an Effective Complaint Handling and Post Market Surveillance and MDR Program for Devices
  11. How to prepare for a Systems-based Inspection
  12. Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products
  13. Reporting Failure Investigations and Process Deviations
  14. How to Develop an Effective Complaint Handling and Post Market Surveillance and MDR Program for Devices
  15. Field Actions and Their Management – Recalls, Product Recovery 
  16. Supplier Qualification and monitoring programs

Her wide-ranged experience and recognized expertise in these areas have acquired her guest speaker positions worldwide, which include several FDA validation workshops (for FDA investigators), and has teached hundreds  of public and onsite CAPA and Process Validation courses for Pharmaceutical, Biologics, and Medical Device manufacturers.   She has worked closely with CDRH's FDA HACCP team for both promotion of Risk Management and training of over 1000 individuals (industry and FDA).

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