Florestal Consulting & Associates

Florestal Consulting & Associates was founded by Marie Florestal in 2002 after twelve years of Pharmaceutical industry experience.  Over the years, we have helped our clients:

 

  • Conduct effective quality system and GMP investigations
  • Identify and implement corrective and preventive actions that address the root cause and eliminate recurrence
  • Verify that proposed actions will address the nonconformance  and does not adversely affect the product
  • Monitor trends and implement meaningful metrics
  • Achieve a state of sustainable compliance 

Florestal Consulting & Associates: Outstanding Experience

Learn more about the Founder:

 

Marie Florestal is a GMP and Quality Systems Subject Matter Expert (SME) whose career in the Pharmaceutical / Medical Device arena spans two decades of assisting companies in:

 

  • Bringing new products to the market
  • Achieving a sustainable regulatory compliant system, and
  • Remediating FDA 483 citations / consent decree injunctions.


Marie’s diverse career in the pharmaceutical industry began with Novartis Pharmaceuticals (formerly Ciba Geigy) as an Analytical Chemist where she performed testing on Raw materials, Active Ingredients and Finished Products. Her ten-year career with Novartis encompassed many roles of increasing responsibilities as a bench Chemist to Assistant Manager of Stability/Compliance. During her tenure at Novartis, Marie was instrumental in implementing a LIMS system for the QA/QC and Stability departments which effectively managed the lifecycle of products.  She has also worked as a Chemistry, Manufacturing and Controls (CMC) lead that assisted in regulatory filings with FDA.   The experience gleaned from her many roles at Novartis helped to form a strong foundation of Quality, Compliance, and a willingness to extend those best practices to other pharmaceutical and medical device companies struggling in the area of regulatory compliance.

 

 

 In October 2002, Marie started Florestal Consulting & Assoc. Corp., a consultancy organization that provides strategic Quality, Regulatory, and Compliance services to the Pharmaceutical and

Medical Device industries.  In this capacity, Marie provided Quality, Regulatory and Compliance services to Schering Plough Pharmaceuticals, and GlaxoSmithKline in their Consent Decree remediation efforts.  At Schering Plough, she spearheaded a Process Redesign effort to harmonize a Global Document Management System between the NJ, and Puerto Rico facilities.

 

In December 2006, Marie assisted GlaxoSmithKline’s Cidra, Puerto Rico facility in the remediation of its Consent Decree injunction as an Investigations Team mentor.  In this role, Marie’s responsibilities included evaluating/investigating manufacturing process deviations, identifying root causes and implementing appropriate / effective corrective and preventive actions (CAPAs).

 

Marie’s depth of experience also includes developing and conducting a training program entitled: Complying with cGMPs 21 CFR Parts 210 and 211.   This 2-day course provided attendees with the tools necessary to (among other things) overcome common challenges for cGMPs, determine cGMP requirements for QC and lab controls, and evaluate common FDA trigger points

Learn more about Florestal Consulting & Associates:

Our principles

Our consultants

 

Our Services

We are a full-service GMPs and Quality systems consulting group. See an overview of our services.