Management Quality

FORMER FDA INVESTIGATOR & COMPLIANCE/REGULATORY AFFAIRS/QA MANAGEMENT EXECUTIVE

Results-focused former FDA Investigator, with extensive RA/Compliance/QA management experience in FDA regulated industries. Technical expertise covers aseptic processing and parenteral drug manufacturing operations; numerous dosage types such as solids, semi-solids, liquids, and aerosols; medical devices; biologics; in-vitro diagnostics; APIs.

Competencies include strong and successful compliance history; continuous improvement processes; quality systems implementation and audits; documentation and batch record compliance review and assessment; supplier quality management; validation documentation approval and audit; crisis management; project management; and FDA communications and interaction.

EXPERTISE AREAS

• Full dominium of 21CFR cGMP regulations and related guidance documents for varied product types (e.g. 21CFR 58; 210, 211, 314; 600, 820; CP7356.002, QSIT)

• Quality System Implementation; Audit; Pre & Post PAI Preparation Support

• Supplier Quality Management

• Advise for and Management of FDA and Regulatory Agencies Inspections

• Control and disposition of non-conforming product

• Investigations and Corrective & Preventive Action System Management

• Batch Record Review and Release

• Customs Communications Management

• Regulatory and State Licensing (FDA, KEMA, DEA, PRHD, Distribution Centers)

• Enforcement Policy Management and Field Actions (e.g. Consent Decrees; Field Alerts; Recalls Management Complaints; Investigations)

• European regulations

• Medical Device Supplier Quality Audits VS ISO Standards

ACHIEVEMENTS

• Established a more robust External Quality Management process at Fougera Pharmaceuticals Inc. (Fougera)

• Revamped Fougera’s Deviations system by updating the processes and corresponding SOPs and related forms to be more user-friendly. Contributed to the lowering of the number of open Deviations by 50%. Established the Quarterly Deviations Report, distributed to management.

• For over a year, was the Management Representative in Fougera’s Quality Review Board (QRB), coordinating the meetings and keeping the Minutes and meeting Records. Instrumental in establishing the QRB SOP, Mission Statement and Quality Policy.

• Revamped MAQUET’s Supplier Quality Audit Program by streamlining and updating the processes and corresponding SOPs and related forms; and audit scheduling. Established an

alignment effort between the three sites (Dorado, CA, and NJ) to share audits and related information.

• Revamped Bard’s Internal Quality Audit Program.

• Lead Auditor Certified by Bard.

• Established (led the definition, documentation, and implementation of) a Regulatory Affairs Department Section, to manage the ANDA and NDA (CMC Sections) previously handled by Lachman Consultant Services, resulting in substantial savings for the Company.

• Established redesigned quality systems in IPR/Astra Zeneca as follows:

Change Control system

API global system

QA Agreements

• Established a Regulatory Affairs Department Section in ICN.

• Less than three months FDA turnaround approval time for CBE submissions, when normal time was approximately six months. These comprehensive and clear FDA submission packages resulted in verbal recognition from the Center of Drug Evaluation and Research (CDER, Carl Beck) for their thoroughness and accuracy.

• Mentored and developed staff (technicians, clerical staff) to occupy management positions (Manager, Supervisor) in IPR and other large companies.

• Established and presided over ComplianceWorks! Inc., a corporation dedicated to providing regulatory, compliance and training services. The corporation provided services to Janssen Farmaceutica in Belgium; Boehringer-Ingelheim in Barcelona, Spain; CEDECAM in Mexico; Wyeth, Guayama, PR.

• First San Juan Investigator to be selected out of over one hundred applicants, for FDA’s Long Term Training Program. This is a one-year Program, which covered tuition, books and full salary while completing a Medical Technology Program. Upon completion of the Program, assigned to conduct inspections of Clinical Investigators, IRBs, Blood Banks and sterile (terminal, aseptic, gamma radiation) manufacturing operations.

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