Marie Florestal

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Marie Florestal

  1. 1. Marie J. Florestal, BS, MPA mjflorestal@gmail.com http://www.linkedin.com/in/marieflorestal http://investigations101.blogspot.com/ PROFILE Expert senior consultant with two decades of experience in the pharmaceutical, medical device and biotechnology companies. Worked extensively with these companies in establishing systems that are compliant with applicable GMP / QS regulations and sustainable over the long term. Mentored personnel in conducting effective Quality Systems investigations, Process re-design and Remediation of systems to comply with commitment made from regulatory citations and consent decree injunctions. Past consulting assignments involved working with major pharmaceutical/biotech companies in: ⇒ Conducting effective quality systems investigations that incorporates identifying the nonconformance, implementing appropriate containment, investigating the nonconformance to identify the root cause, identifying and implementing actions to correct the nonconformance, and validating or verifying that those actions will work and will not adversely affect the product ⇒ Developing a Quality Systems approach to pharmaceutical manufacturing ⇒ Implementing cGMP compliant systems at facilities under consent decree injunctions, FDA-483s, and Warning Letters. ⇒ Coordinating, preparing and executing compliant stability programs as well as assisting in the development of systems and databases to enhance Stability operations. PROFESSIONAL EXPERIENCE Consultant, Stryker Orthopaedics Mahwah, NJ CAPA Analyst September 2008 – Present ⇒ Provide mentoring services to investigators on the process for conducting effective quality systems investigations that incorporates identifying the nonconformance, implementing appropriate containment, investigating the nonconformance to identify the root cause, identifying and implementing actions to correct the nonconformance, and validating or verifying that those actions will work and will not adversely affect the product. Consultant, Bristol Myers Squibb New Brunswick, NJ Training SME June 2008 – July 2008 ⇒ Developed role-based curricula for 4 functionally-distinct groups within AR&D over an 8 week period ⇒ Aligned curricula with the various roles, technical levels and/or functions in those groups ⇒ Evaluated SOPs, Quality/Compliance Requirements, Analytical Methods, Instrumentation Used ⇒ Identified gaps and recommended follow-up action ⇒ Facilitated meetings with Steering Committee to reaffirm the current (‘real world’) job requirements / functionality for each of the technical levels and/or functions within each of the 4 groups Consultant, Celgene Corp. Summit, NJ Quality Systems/ Stability Project Manager July 2006 – May 2008 ⇒ Staffed and implemented a Stability department compliant with regulatory guidances (ICH, FDA, EU) and responsible for meeting stability commitments and submissions for regulatory filings. ⇒ Established, implemented, and maintained SOPs for daily Stability operations. ⇒ Reviewed analytical data for clinical and commercial release, annual product review, method development, and method transfer stability studies. ⇒ Implemented and managed process for stability investigations and monitored CAPA effectiveness. ⇒ Lead quality based initiatives at both a documentation and process level in order to optimize stability operations. ⇒ Ensured continuous improvements of established stability procedures and adherence to new systems/processes.
  2. 2. Consultant, GlaxoSmithKLine Cidra, Puerto Rico Lab and Manufacturing Operations Auditor Sept. 2005 – July 2006 ⇒ Performed quality systems audits to ensure compliance with industry regulations ⇒ Worked with site personnel on all laboratory and manufacturing operations investigations ⇒ Facilitated investigation process to identify root cause and implement effective CAPAs ⇒ Monitored process for CAPA effectiveness ⇒ Conducted follow-up to GMP Investigations, Planned Deviations, Change Control, NDA Field Alert, QC Lab investigations Consultant, Schering-Plough Springfield, NJ Documentation Project Manager, MSS June 2004-Sept. 2005 ⇒ Revised and prepared training materials for Global Pharmacovigilance Standards, Medical and Safety Services (MSS) Standard Operating Procedures, Corporate Policies and Procedures ⇒ Implemented training assessment tool for global target audience ⇒ Developed harmonized Corporate Policies and Procedures and Global Pharmacovigilance Standards pertaining to MSS Standard Operating Procedures to ensure compliance with Global Pharmacovigilance legislation ⇒ Evaluated training metrics, identified training gaps, and developed appropriate training curriculum ⇒ Created and maintained database for Phamacovigilance Standards and Work Instructions ⇒ Served as Global Liaison for Pharmacovigilance activities Trainer, Center for Pharmaceutical Training Dec. 2003 Complying with cGMPs 21 CFR Parts 210 & 211 Developed Training manual and curriculum for national pharmaceutical training company and provided training and evaluation assessment of attendees ⇒ Training Program included: o Overcoming common challenges for cGMPs o Ensuring cGMP compliance in various stages of product development o Determining cGMP requirements for QC and Lab controls o Master Validation Plan o Writing and Auditing cGMP documentation o Key essentials for successful PAI and cGMP audits o Common FDA trigger points and cGMP related FDA 483s Consultant, Schering-Plough Cranford, NJ Process Re-design Manager Sept. 2003 – June 2004 ⇒ Communicated the company vision for cross-Site harmonization and design responsibilities and shared best practices across Site Teams. ⇒ Tracked Documentation status and progress, and presented findings to Process Redesign Steering Committee. ⇒ Facilitated resolution of escalation issues concerning documentation practices ⇒ Chair the Documentation Quality Management System Steering Committee. ⇒ Ensured that Site and cross-Site reviews/approvals of plans take place during and following each of the 6 phases of Process Redesign. Consultant, Schering-Plough, Union, NJ Technical Documentation Specialist April 2003-Sept. 2003 ⇒ Assisted Technical Documentation Department in the re-engineering process ⇒ Managed the implementation of a new document management system ⇒ Developed project plan to successfully migrate three thousand active procedures into a Global Electronic Document Management System (GEDMS) ⇒ Served as Project Manager for global document management system ⇒ Identified gaps in current document management system and develop protocols and/or procedures to achieve compliance ⇒ Developed Departmental Standard Operating Procedures and Protocols ⇒ Audited Documentation Department policies and procedures for adherence to GMP Documentation Practices and company operating procedures __________________________________________________________________________________ Marie J. Florestal http://www.linkedin.com/in/marieflorestal http://investigations101.blogspot.com Page 2 of 4
  3. 3. Consultant, Schering Plough, Manati, Puerto Rico Remediation Project Manager Sept. 2002-April 2003 ⇒ Developed a comprehensive system for documenting and managing all evidence packages submitted for closure of FDA 483 and EMEA observations ⇒ Incorporated and implemented effective strategies for streamlining the review process of all open FDA 483 and EMEA observations by the Remediation Team ⇒ Monitored all incoming evidence packages for compliance to regulations and fulfillment of original commitment Hurley Consulting Associates, Chatham, NJ Regulatory Affairs Manager May 2001- Sept. 2002 Managed the daily activities within the Regulatory Affairs department including routine submissions such as: information amendments, protocol amendments, Chemistry Manufacturing and Controls (CMC) supplements and review of informed consent document. Served as FDA contact person to handle all FDA inquiries and requests. Also served as Project Manager for various regulatory projects where duties included: ⇒ Review of clinical protocols and clinical study reports to ensure adherence to GCP ⇒ Ensuring that Chemistry, Manufacturing and Controls submissions meet all regulatory guidelines and assess strategy for submission ⇒ Providing Regulatory and Analytical guidance to multiple pharmaceutical clients while ensuring strict adherence to federal guidelines, regulations, and site SOPs ⇒ Preparation of client SOPs within the Regulatory and Analytical guidelines ⇒ Ensuring that documents are submitted in a timely manner and are scientifically valid ⇒ Preparation of all IND/NDA domestic and foreign Adverse Event reporting (MedWatch) and submission of IND/NDA correspondences, annual and periodic reports ⇒ Delegation of work assignments and training of six direct reports ⇒ Drafting briefing documents in preparation for FDA and client meetings Novartis Pharmaceuticals Corp., 1991-2001 Quality Control Scientist May 1991-1997 ⇒ Performed quantitative/qualitative tests using principles of wet chemistry, HLPC GC, FT-IR, NMR, UV- Vis., and Karl Fisher on all marketed and investigational products ⇒ Conducted Methods Development / Validation / Tech. Transfer testing ⇒ Conducted Equipment Troubleshooting ⇒ Assisted in the development of new GMP infrastructure for QC department. ⇒ Wrote and revised numerous SOPs ⇒ Conducted lab investigations and final report on incident ⇒ Trained chemists in GMP and cGMP regulatory guidelines ⇒ Assigned and maintained a smooth work flow within the lab to ensure the meeting of due dates Stability Administrator/Compliance May 1999- May 2001 East Hanover, NJ Managed the daily activities of the Stability department in order to ensure timeliness of product commitments. Extensive knowledge of ICH and SUPAC guidelines. Ensured that all regulatory guidelines were followed as per departmental SOP and regulatory mandates. Worked independently and collaboratively on project teams. Evaluated laboratory data for safety and efficacy trends. ⇒ Worked extensively with Drug Regulatory Affairs (DRA) on Chemistry, Manufacturing and Control submissions ⇒ Prepared and Approved Annual Product Reviews (APRs), and Change Control documents ⇒ Designed appropriate stability protocols and commitments for NDA, ANDA, and Post-approval filings ⇒ Managed stability testing for three (3) separate functions: QA (Marketed Products), Technology (Development, Prescription, and OTC Marketed/Non-Marketed products), and Over-The- Counter R&D (Development of New Products) ⇒ Compiled, reviewed and trained personnel on all relevant departmental SOPs ⇒ Implemented and maintained stability programs for follow-up stability testing on annual and investigational batches __________________________________________________________________________________ Marie J. Florestal http://www.linkedin.com/in/marieflorestal http://investigations101.blogspot.com Page 3 of 4
  4. 4. ⇒ Developed system to track and report stability alerts with notification of appropriate departmental managers ⇒ Monitored validation lots and designed appropriate reports for submission to DRA ⇒ Designed, reviewed and approved stability studies ⇒ Contributed to continuous improvement processes within the stability department ⇒ Prepared and implemented project-specific training programs and materials for internal and external staff LIMS Database Administrator 1997-2000 Worked extensively with the developer of the QDIS LIMS in order to customize system for optimum laboratory use. Participated in and tested analytical and stability modules to ensure system integrity and efficiency. ⇒ Developed appropriate reporting format that were in compliance to FDA regulatory guidelines (21CFR 11) ⇒ Develop UAT protocol and summary report ⇒ Developed test scripts for user acceptance ⇒ Served as primary troubleshooter and problem-solver ⇒ Developed a comprehensive training manual for the successful training of all QA/QC departmental personnel and analysts ⇒ Participate in multi-disciplinary task force in support of stability objectives PROFESSIONAL DEVELOPMENT & ASSOCIATIONS Healthcare Businesswomen’s Association (HBA) Problem Solving, Decision Making and Planning American Society for Quality American Association of Pharmaceutical Scientists (AAPS) Regulatory Affairs Professional Societies (RAPS) Institute of Validation Technology (IVT) International Association for Pharmaceutical Science and Technology (PDA) GMP Trends Certified by the New Jersey Pharmaceutical Quality Control Association (NJPQCA). Karrass Seminar: Effective Negotiation EDUCATION Seton Hall University, South Orange, NJ 1995-1997 Master of Public Administration (MPA)/Health Care Management Cum Laude Pace University, New York, NY 1985-1989 Bachelor of Science (BS)/Chemistry. __________________________________________________________________________________ Marie J. Florestal http://www.linkedin.com/in/marieflorestal http://investigations101.blogspot.com Page 4 of 4

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