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Regulatory Expertise:

• Audits – Certification/ Due Diligence/ Food & Drug Administration Amendments Act (FDAAA)/ Dietary Supplement/(GMP (Medical Device)/ GMP (Pharmaceutical)/ GMP (Biologic)/ GLP (Laboratory, Animal)/ ISO/ Quality System Inspection Technique (QSIT)/ Quality System Regulation (QSR), Electronic Records & Electronic Signatures; 21 CFR Part 11, FDA - 483 and Warning Letter Responses/Consent Decree, Hazard Analysis, ISO – 13485:2016/ 9001/9002/ 9003/14971:2007 (Risk Management)/ Active Implantable, Medical Device Directive (AIMD), Medical Device User Fee & Modernization Act (MDUFMA)/ QSR; 21 CFR 820/ Medical Devices Directive (93/42/EEC)/ Active Implantable Medical Devices Directive (90/385/EEC)/ In Vitro Diagnostic Medical Devices Directive (98/79/EC)/ OSHA, Quality Assurance, Quality Control, Quality Management, Quality Systems Development/ Implementation, Regulatory Affairs, Six Sigma, Training
• Biologics – Fractionation/ Monoclonal Antibodies/ Vaccines
• Biotechnology – Cell Culture/Bioprocess Technology/Genetic & Protein Engineering
• Clinical Development – Research/Preclinical/Point of Concept/Phase I/Phase II a/b/Phase III/Phase III b – IV/Registration/Launch/ICH GCP E6(R2)
• Combination Products – Single-entity, Co-packaged and Cross-labeled combination products; Sections 21 CFR 3.2(e)(1), (e)(2), (e)(3) or (e)(4); examples include: catheters, condoms, injector pens, kits containing devices, metered dose inhalers, syringes, and transdermal patches
• Compounding Pharmacy – Sections 503A & 503B of the Federal Food, Drug, and Cosmetic Act
• Dietary Supplement – Botanical/Mineral/Vitamin supplements; 21 CFR Parts 110, 111 and 117; Small Entity Compliance Guidance, Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, and Dietary Supplement Labeling Guide
• Medical Devices – Class I/ Class IIa/ Class IIb/ Class III
• Pharmaceuticals – Antibiotics/ API/ Bulk Chemicals/ Creams & Ointments/ Non-Sterile Liquids/ Solid Oral Dosage Form/ Parenterals

PROFESSIONAL EXPERIENCE:

Industry Consultant 1992-Present Principal Consultant & Project Manager

Assists clients to develop and implement quality assurance and regulatory strategies for compliance with governmental regulations.

Quality Assurance

• Functioned as Interim Director of Quality Assurance and Compliance for a global biotech, a biopharmaceutical, and a consumer heathcare company, accountable for: 1) management and quality oversight of the Quality Management Systems: Annual Product Reviews, Change Control, Corrective Action and Preventive Action (CAPA), Compliant Handling, Documentation, Exceptions and Investigations, External Audits and Risk Assessment and Mitigation; 2) management of Contract Organizations; 3) review of batch records, specifications, test results and validation protocols; 4) Audit Plan execution and development; 5) writing and monitoring of Quality Technical Agreements; and 6) coaching and mentoring a small team (≤25 employees/consultants).
• Functioned as the Lead Auditor for numerous product audits for companies under Consent Decree. Responsible for the content and accuracy of the formal final report submitted to senior

company officials, legal counsel, and regulatory agency officials.

• Conducted gap assessments, mock inspections, and quality audits (system, process and product) of pharmaceutical, biologics, biotechnology, and medical device manufacturers producing finished drug products and devices within the US and overseas in accordance with the international regulatory agency requirements.
• Worked with eleven companies under Consent Decree to revise corporate quality standards, review release documentation and make recommendations for improving reports associated with lot release

including batch records and deviations and investigations. Mentored quality personnel on the cGMPs as they pertain to their specific job functions.

• Functioned as a Principal Investigator for pharmaceutical, biotechnology and medical device clients under consent decree: generated and critically reviewed process- and operational-related failure investigations per the clients’ commitments under US and international Enforcement Directives and Policies; and mentored engineering and manufacturing personnel on regulatory expectations for a compliant deviation investigation.
• Critically reviewed the Quality Control sections of executed batch records, Laboratory Incident Reports (LIRs), Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations for a generic and proprietary pharmacutical company that had been issued a warning letter, and provided recommendations to ensure compliance, clarity and accuracy.
• Acted as a Supplier Quality Manager for External Manufacturers and Supplier Audits Department for

a major pharmaceutical company, accountable for ensuring: an effective supplier quality audit program, an effective FDA Readiness program for key critical suppliers, and the proactive identification and alerting of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or business entity.

• Worked with the Department Heads for a generic pharmaceutical company to establish and implement a cohesive company-wide Change Control System involving a Change Control Committee.
• Responsible for managing complaint documentation: 1) input data into manageable reports,

ensure the integrity and completeness of Complaint Files, and analyze and present trend data to management; 2) reviewed and approved complaint investigations and complaint closure letters;

3) participated in Management Review Meetings; 4) trained client personnel; and 5) maintained procedures and practices related to complaint handling to assure compliance with ISO and FDA regulations.

• Responsible for evaluating CAPA effectiveness for quality areas requiring improvement, including the preparation of responses to corporate audits and regulatory inspection observations and the tracking of the resulting CAPAs.
• Assisted in the implementation and validation of EDMS and QMS supporting centralized and

consolidated tracking, storage, retreival, and archival of electronic records and documentation used for critical business processes that require regulatory reporting.

• Worked with a generic pharmaceutical company’s Recall Committee to: conduct review meetings, prepare recall strategies, define responsibilities of personnel involved in recall

activities, prepare recall notifications, and the writing of recall procedures.

• Reviewed deviations and investigations that pertain to the release and certification of contract manufacturing lots and batches and initiated the submission of Field Alert Reports (FARs) as specified in 21 CFR 314.81(b) and 7356.021 Drug Quality Reporting System NDA Field Alert Reporting.
• Transferred knowledge, quality system documentation and methods of manufacturing and analysis, from R&D through full-scale production during scale-up/-down activities conducted during the

phases of technology transfer between facilities within the same company or outside the company (i.e., certified vendors and suppliers) for processes performed during the manufacture of oral solid and liquid, semisolid, biotechnology-derived dosage forms, parenteral solutions, and patches.

• Collaborated with contract manufacturers and third-party vendors to assess and evaluate the

product review parameters necessary to draft Annual Product Reviews for a virtual parenteral drug manufacturer.

• Developed Master Batch Production Records for the Operations, Packaging and Laboratory activities performed in the manufacture of biologics, biotech, and pharmaceutical dosage forms.
• Established and installed the following quality systems to certify acceptable compliance for the operating disciplines in a company: Batch Record Management; Building Control Systems including Utilities; Change Management;  Data  Acquisition;  Documentation  Management;  Equipment Tagging and Requisition; Environmental Monitoring; Investigation and Deviation Management; Locked Inventory including packaging and labeling controls; Lot Numbering; Materials

Management; Metrology; Part Numbering; Preventative Maintenance; Process Analytical Technology; Project Management; Strategic Planning; Validation; and Warehouse.

Training

• Developed Deviation Investigation Training Modules and provided training on Investigations and Root Cause Analysis using Risk Management and Six Sigma Methods and Tools as part of a Remediation project for an international vaccine and biotechnology manufacturer.
• Conducted mock inspections and led PAI Readiness Assessment Programs that involved training personnel on how to host an inspection, how to answer questions from inspectors, and how to successfully review the documentation for pivotal qualification or submission batches.
• Developed R&D GMP QA US Training Modules including: Introduction to R&D QA Compliance, Master Document Control, Assay Validation & Method Transfer, Auditing, Batch Release, CAPA, Global Change Control, Deviations & Investigations, Preventive Maintenance and Calibration, and Validation Qualification for an international vaccine and biotechnology manufacturer.
• Revised the Personnel Training, Qualification and Monitoring Program for a contract manufacturing organization used to fill and package biological products for an international vaccine and biotechnology manufacturer.
• Developed a nine-module cGMP/QRS training course for biological pharmaceuticals in conjunction with the University of Maryland.
• Developed an Occupational Health and Safety Awareness Training Program for a Drug Enforcement Administration (DEA) controlled substance manufacturer.

Validation & Compliance

• Functioned as the Acting Director of Validation and Compliance for a biopharmaceutical contract development and manufacturing company specializing in cell culture and parenteral product manufacturing.
• Performed remediation activities for LC-MS/MS and GC-MS/MS analytical method validation deficiencies for compliance with EU and US GLPs.
• Commissioned and qualified the following utilities: gases (compressed air, nitrogen, oxygen, and carbon dioxide); liquids (process water and solvents); steam (process and clean); house vacuum; electrical and drains (process and waste).
• Drafted Facility Qualification Plans (also known as, Facility & Equipment Qualification Plans or Validation Master Plans) for biological, OTC and sterile drug manufacturers; these plans covered facility and equipment, automation, cleaning, process and laboratory and analytical systems.
• Assisted a cold chain supplier in obtaining packaging certification per FDA specification during validation of their cold chain packaging and distribution systems used for the safe and efficient transport of temperature-sensitive products.
• Developed presentations for spreadsheet validation, designing viral clearance studies, and biopharmaceutical manufacturing process validation (an overview) for a validation consultancy.
• Audited computer tracking system for computer validation, centralized documentation management, instrument tracking, data trending and training, and SOP programs for use with LIMS and Microsoft-based systems.
• Conducted development and validation studies on manufacturing processes and equipment during

scale-up/-down activities conducted during technology transfer from R&D to full-scale production, and participated in the creation of the required technology transfer documents.

• Performed process simulation studies for biological dosage manufacturers for small batches

(5000>N>1000) and conventional batch sizes (100,000>N>5000) to demonstrate the aseptic processing capability of the firm’s facility, practices, operating procedures and personnel.

• Evaluated equipment and systems used for cleaning, manufacturing and storage of bulk, intermediate, and finished product to verify adequate design, validation, maintenance, and routine testing for compliance against applicable specifications.

Project Management

• Utilized Process Analytical Technology (PAT) at multiple clients to integrate EBR systems into Manufacturing Execution Systems (MES) that provided capabilities such as order management between enterprise research planning (ERP) and real-time control systems.
• Functioned as a Project Coordinator on a capital project for the construction of a new liquids manufacturing facility for the Consumer Healthcare Division of a major pharmaceutical company.
• Updated and maintained the Scope, Requirements, Schedule, Quality, Project Change and Risk Management aspects of the project plan such that the project was performed safely, on schedule and within budget.
• Launched and managed a registration project for a major pharmaceutical company interested in adding

generic solid and injectable dosage forms (60 molecules) in numerous emerging markets in Europe, Asia and Africa (42 countries).

EDUCATION

West Chester University, West Chester, PA 19383

Course work completed for M.S. Degree in Clinical Chemistry 1988

Alvernia College, Reading, PA 19607

B.S. Degree in BioChemistry (Dual Degrees in Biology & Chemistry) 1984

AWARDS & HONORS

Commendation from the Joint Program Office for BioDefense 2002 Commendation from the Joint Program Office for BioDefense 2004

PROFESSIONAL AFFILIATIONS

American Society for Quality (ASQ), Regulatory Affairs Professional Society (RAPS), Parenteral Drug Association (PDA), International Society for Pharmaceutical Engineering (ISPE)