Consultant
Senior professional with technical, managerial, business process, and scientific knowledge, skilled in regulatory compliance, analytical development, product development, and quality control. Ph.D in Organic Chemistry with over 25 years of experience in the drug and combination product manufacturing, food manufacturing, and environmental industries. Background in parenteral, liquid, solid, and semi-solid drug products, including small molecules (Coumadin®), an Alzheimer’s drug, generic OTC, and sterile products, pain management drugs (Percodan®, Naloxone®, Narcan®, Numorphan® and Naltrexone®), and flavorants (Vanillin).
CORE COMPETENCIES
- Project Leadership/Project Management 21 CFR Part 210/Part 211/Part 820/Part 11
- Quality Plans/Project Plans/Project Charters/21 CFR Part 110/Part 111
- Quality Systems /Procedural Development/ISO 9000/ISO 13485
- FDA Inspections/Remediation/CTD Dossier Preparation
- Gap Analyses/Auditing/Analytical Method /Equipment Validations (IQ/OQ/PQ)
- Change Management/Change Controls/Stability-Indicating Methods/Validations /Transfers
- Corrective and Preventative Action (CAPA)/Validation Master Plans/Cleaning Validations
- Risk Assessment /HACCP FMEA/ICH Q9/Process Improvements
SELECTED ACCOMPLISHMENTS
- Served as subject matter expert and contributed to team remediation accomplishments on various projects involving recalls, warning letters, consent decrees, including:
- Provided technical guidance on combination product design team for metered dose inhaler
- Audited R&D product development and product history reports following warning letter for re-introduction of combination product
- Provided technical input on failure investigation for issues regarding pre-filled syringes
- Reviewed/approved CAPA investigations for laboratory/manufacturing operations regarding outstanding issues related to pharmaceuticals, sterile products, biologics, and combination products
- Prepared training modules for root cause analysis for investigations and CAPAs per FDA and ICH guidelines
- Conducted GMP audits for operational compliance and developed responses to FDA compliance problems, notices of observations, warning letters, and consent decrees
- Audited annual stability reports, protocols, studies, and supporting documentation for data integrity, accuracy, and completeness
- Assessed handling of out-of-specification results, deviations, and CAPAs
- Performed regulatory compliance and risk assessments for laboratory investigation related to remediation activities for FDA warning letter
- Provided guidance for cleaning validation and verification for sterile manufacturer
- Audited formulation R&D documentation of generic formulations for PAIs per ICH Q8/9
- Conducted CMC auditing, specifically assessments of 12 ANDA filings to determine whether product was manufactured and tested in conformity with CMC controls and FDA-approved applications, and whether analytical methods for in-process controls, finished product testing, and stability monitoring were reliable and accurate
- Authored 100% effectiveness recall script for repackaging operation of firm that serves long-term care facilities, and drafted SOP for destruction of controlled substances incorporating DEA Form 41
- Performed independent assessment of business process, roles, responsibilities, and functions of quality unit operations for product development R&D groups according to GxPs/ICH Q9
- Audited LC/MS method validations at clinical trials CRO in support of clinical trials testing, providing GAP analyses comparing methods validation status against current ICH criteria
- Created CTD Module 3 Dossiers and GAP analysis for registering OTC products in domestic/new overseas markets according to principles outlined in ICH Q8(R2), Q9, and Q10
- Provided QA/QC support for clinical documentation at biopharmaceutical company for NDA registration package, revising and editing PK/PD reports, clinical study reports, and CTD Modules 2 and 5
- Authored stability system SOPs for clinical supplies repackaging facility
- Provided subject matter expert support for LIMS implementation per GAMP5 at biopharmaceutical development company
- Managed LIMS stabilization/remediation project, responsible for forensic investigation of system failures, project plan, and final report, supervising 2 subject matter experts responsible for reviewing original LIMS implementation and developing actionable plans to correct on-going issues and system instability
- Prepared, executed, and/or conducted reviews of CSV deliverables for Documentum upgrade, including, but not limited to, compliance assessments, corrective action plans, CSV/SLC documentation, validation plans, user/functional requirements, configuration specifications, protocols (IQ/OQ/PQ, UAT, traceability matrices, etc.), test scripts, test summary logs, and validation summary reports according to GAMP4
- Reviewed and executed test scripts for commissioning of manufacturing equipment and PLC devices, including labelers
- Developed documentation as required for assigned projects (SOPs, guidelines, summaries, training, etc.)
- Provided compliance support for computer validations activities for manufacturer under consent decree, including:
- Reviewed and certified computer performance qualification documents for enterprise-wide applications, spreadsheets, operating systems, user interfaces, etc., under terms specified in consent decree document and compliance with CGMP’s and 21 CFR Part 11
- Audited unexecuted protocols and executed computer system validation studies for applications, such as, but not limited to, SAP, Documentum, TrackWise, CMMS, EDMS, WMS, ISOtrain, etc., for conformance to predetermined acceptance criteria and compliance with CGMP’s, 21 CFR Part 11, and GAMP
- Assured documentation, such as change control, SOP’s, training records, etc., conformed with terms specified in consent decree and compliance with CGMP’s
- Authored reports summarizing deficiencies of protocols and/or study results for subsequent FDA review
- Issued approval certificates for subsequent protocol execution and/or study results following resolution of all issues and compliance with CGMP’s and 21 CFR Part 11
- Trained 3 consultants to support computer validation efforts and successfully met consent decree commitment project timelines
- Served as subject matter expert for computer system validation related to Part 11 questions, issues, and GAP analysis
- Reviewed current SOPs and work instructions for predicate rule compliance, security requirements, disaster recovery, and data retention plans
- Managed operations of quality control unit with supervision of technical personnel supporting new product research and development, GMP laboratory documentation control, and stability, including:
- Prepared department budget of $3,000,000 for staffing and $500,000 for capital equipment
- Designed new analytical testing laboratories in conjunction with facilities expansion
- Prepared commissioning and validation documentation for major laboratory equipment (e.g., GC, HPLC)
- Reviewed and approved IQ/OQ/PQ validation protocols and executed protocols for CGMP compliance
- Reviewed sponsor-developed clinical trial protocols for new carrier/drug combinations
- Authored compliance documents, stability reports for CMC sections, SOP’s, specification documents, and certificates of analysis ( COA’s ), stability portions of CMC section for NDA filings, out-of-specification (OOS) investigation reports, GLP toxicology sample analysis summary reports, and clinical pharmacokinetic data reports, and implemented change control procedures
- Authored primary ICH harmonized stability protocols for transfer to contract research organizations and reviewed data received for product quality assurance
- Authored change control SOP and established company change control review board
- Successfully completed computer validation report for laboratory Turbochrom Workstation
- Contributed to writing requirements and functional specifications documents in compliance with 21 CFR Part 11 for Turbochrom Client Server as member of corporate Turbochrom Validation Team
- Interacted with FDA during routine inspection and eliminated potential 483 observations
- Authored quality function SOPs and conducted training on new and revised SOPs
- Managed operation of R&D lab with 8 technical personnel for new semi-solid generic OTC product development in support of overall business process, including:
- Coordinated and tracked cleaning validation testing activities to ensure compliance, prepared cleaning validation master plan (Team Leader of Cleaning Validation Project)
- Prepared 13 product cleaning validation protocols, managed successful execution, and authored reports within 6 months without any FDA 483 observations upon re-inspection
- Reviewed incoming method validation reports from contract research organizations ( CROs ) for accuracy, completeness, and compliance with USP and FDA method validation guidelines
- Facilitated transfer of new methods to quality control group from developing groups, and prepared technology transfer reports certifying acceptable methods transfers
PROFESSIONAL EXPERIENCE
- PharmaBasics, Inc., Senior Consultant (Tarrytown, New York) – 2003 to Present
- Emisphere Technologies, Associate Director, Quality Support (Tarrytown, NY) – 2000 to 2002
- G&W Laboratories, Mgr., Analytical Research/Methods Dev. (South Plainfield, NJ) – 1997 to 2000
- Clay-Park Labs, Inc., Mgr., Contract Product Dev., Analytical Laboratory Mgr. (Bronx, NY) – 1995 to 1997
- DuPont Merck Pharma. Co., Mfg. Div., Principal Scientist, Analytical Tech. (Garden City, NY) – 1993 to 1994
- DuPont Merck Pharma. Co., Mfg. Div., Mgr., Analytical Tech. Support (Garden City, NY) – 1990 to 1993
- Pall Corporation, Laboratory Mgr. (Glen Cove, NY) – 1989 to 1990
- Pepsico, Inc., Senior Chemist, Concentrate Operations (Valhalla, NY) – 1987 to 1989
- Lederle Labs, (American Cyanamid), Analytical Dev. Chemist (Pearl River, NY) – 1986 to 1987
- Revlon Health Care, Senior Chemist, Lab Supv. (Tuckahoe, NY) – 1981 to 1986
- Chemtech Consulting Group, Inc., Group Leader (New York, NY) – 1980 to 1981
- Equitable Environmental Health, Inc., Analytical Chemist (Woodbury, NY) – 1979 to 1980
EDUCATION
- Ph.D. in Organic Chemistry, Polytechnic University, Brooklyn, NY
- Master of Arts in Chemistry, Queens College, Flushing, NY
- Bachelor of Science in Chemistry, Queens College, Flushing, NY
- Master of Science, Geochemistry, Rensselaer Polytechnic Institute, Troy, NY
CERTIFICATION
- Certified API Auditor for Q7A, SGS Certification – 2010
AFFILIATIONS
- American Association for the Advancement of Science
- American Association of Pharmaceutical Scientists
- American Chemical Society
- Association of Official Analytical Chemists
- American Society for Quality
- International Society for Professional Engineering
- New York Academy of Science
- NY Hall of Science
- New Jersey Pharmaceutical Association of Science and Technology
- New Jersey Pharmaceutical Quality Control Association
- Parenteral Drug Association
- Regulatory Affairs Professional Society
- SigmaXi
PUBLICATIONS AND PRESENTATIONS
Presentations
- “An Approach to Process Optimization in the Pharmaceutical Industry using a System based on the HACCP Concept,” ACS Pittsburgh Conference, New Orleans, LA (3/95)
- “Considerations and Trends in Technology Transfer,” ACS Pittsburgh Conference, New Orleans, LA (3/95)
- “Reinvestigation of the Larvicidal Activity of Marigold Oil,” with M.M. Green, D.J. Sutherland, and C.R. Hibben, 199th ACS National Meeting, Boston, MA (4/90)
- “Simple Conversion of a Packed Column Gas Chromatograph to Wide Bore Capillary Operation,” with M.J. O’Hare, C.R. Rehm, and J.E. Zarembo, 190th ACS National Meeting, Chicago, IL (9/85)
- “Gas Chromatographic Analysis of Ethylene Oxide Residues for Pharmaceutical Applications,” with M.J. O’Hare, C.R. Rehm, and J.E. Zarembo, ACS Pittsburgh Conference, Atlantic City, NJ (3/84)
- “Problems and Interferences Affecting the Analysis of Chlorinated Pesticides and PCBs in Environmental Samples,” with A. Schoffman, ACS Pittsburgh Conference, Atlantic City, NJ (3/83)
- “Problems, Demons and Gremlins Associated with the Analysis of Chlorinated Pesticides and PCBs,” Analytical Chemistry Symposium, CUNY Graduate Center, New York, NY (11/81)
Publications
- “Validation of Laboratory Information Systems” with Alex M. Zislin amd Rory Budihandojo in Validation of Pharmaceutical Processes, Third Edition, Ed by J. Agalloco and F. Carleton, InformaUSA, Sept. 2007.
- “Larvicidal Activity of Tagetes Minuta (Marigold) Towards Aedes Aegypti,” with M.M. Green, D.J. Sutherland, and C.R. Hibben, Journal of the American Mosquito Control Association Vol. 7, No. 2 (1991): 282-286.
- Investigation of the Mosquito Larvicidal Activity of the Oil of Marigolds, Doctoral Thesis (1987)
- “Relative Retention Time Calculation in Accordance with EPA Method 608,” Perkin-Elmer Sigma Basic Software Note CCCSN-10400 (1982)
- Adsorption of Phosphorus in Silica Gel as Influenced by Treatment with Trimethylchlorosilane: To Develop a Suitable Diluent for Fine Textured Soils, Master of Science Thesis (1976)
- “Quantitative Spectrophotometric Determination of Chloride Ion in Rainwater and Snow, Nucleus Journal of Science IX (1971): 10
