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Resume of ZEV
Consultant
EXPERTISE AND SERVICES
Biochemist, Quality Assurance Expert, Validation, Manufacturing and Packaging Specialist, QA cGMP Compliance Consultant, Pharmaceutical and Medical Device Technical Management Consultant, Expert Consulting ServicesExpertise in quality assurance, validation, manufacturing and packaging, and technical management experience in the pharmaceutical/medical device industries.
This KKAI consultant has a strong QA cGMP compliance background in Title 21 CFR §58, 210, 211, 600, and 820; FDA QSIT, ISO 13485; direct interaction with the FDA and third parties; process validation; preparation of manufacturing and packaging records; and review of batch records for release (API, manufacturing and finished goods).
This consultant's work experience includes a working knowledge of SPC; preparation of annual product reviews; knowledge of nonconformance and deviation investigations/reports; change control; ability to prepare and review technical documents; perform audits-internal and external; and OOS, OOT. Additional areas of specialty include preparation of IQ/OQ protocols for process and ancillary manufacturing equipment, e.g., blenders, tablet presses, mixers, tablet dedusters, coating systems and preparation of SOPs for manufacturing equipment use and cleaning.
This consultant's work experience includes evaluation of SOPs used to establish the Design History Files (DHF), and investigation of data/information in DHF and design controls, document controls, purchasing controls, and process validation.
Highly experienced in areas including preparation of standard operating procedures for setup, operation, and cleaning of manufacturing equipment, receiving raw materials, sampling raw materials, shipping finished goods, warehouse operation of FIFO, calibration of equipment, as well as review of process validation protocols, qualification protocols, and technology transfer documents
PRINCIPAL INDUSTRIES SERVED
Medical Device, Pharmaceutical, Quality Assurance
EDUCATION
B.S., Biochemistry, University of Maryland, College Park, MD
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.
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Providing expertise in biochemistry, quality assurance, validation, manufacturing and packaging, QA cGMP compliance, pharmaceutical and medical device technical management, and related expertise to a wide variety of clients.
Speak to this experienced, world-class expert now.
- Call (317) 735-4699
- E-mail zev@rapid-response-consulting.com
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Sr. QA Consultant, The Medicines Company, Waltham MA and Parsippany NJ
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Prepared the annual product review for a anti-thrombin drug; wrote the executive summary for presentation to the executive management group. Assessed and prepared recommendations for improvements in the SOPs in the Manufacturing Group. Was responsible for the Manufacturing/QA Product Complaint system; developed new SOPs; Chaired the Product Complaint committee. Reviewed and corrected Master Production Records from CMOs, Process Validation and API Validation protocols, clinical and commercial API batch records, and clinical and commercial productions for product release.
Sr. QA Consultant, Acambis, Cambridge MA
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Was responsible for vaccine data and technical report review (Title 21 CFR §58, 210 and 211). Audited clinical toxicology studies on mice and monkeys in accordance with Title 21 CFR §58. Audited Research and Development notebooks; the data from which was used in technical documents (Title 21 CFR §58 and 211). Audited and reviewed technical documents for a new vaccine (transgenetic chimeric virus); the documents were use to support the BLA submission.
Consultant, Parexel Consulting
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Prepared qualification guidance documents for a Korean biotechnology facility, e.g., Generation of WFI, Generation of Clean Steam, Technical Guidance for Depyrogeneration Ovens, Technical Guidance for Lyophilizator, etc. Prepared IQ/OQ protocols for deionized water system(s). Prepared IQ/OQ protocols for process and ancillary manufacturing equipment, e.g., blenders, tablet presses, mixers, tablet dedusters, coating systems, etc.
Consultant, MediSense, Bedford MA
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Was responsible for medical device validation/equipment qualification (Title 21 CFR §820 and ISO13485). Prepared and executed IQ/OQ protocols for manufacturing equipment. Prepared SOPs for manufacturing equipment use and cleaning.
Consultant, Bio-Reg Associates, Inc., Beltsville MD
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Provided expertise in Quality Assurance for a Medical Device/IVD company under consent decree (Title 21 CFR §820 and ISO13485). Evaluated the SOPs used to establish the Design History Files (DHF). Investigated data/information in DHF and the design controls, document controls, purchasing controls, process validation, etc. Mentored the Subject Material Experts (SMEs) in responding to potential questions by FDA investigators.
Quality Assurance Consultant, Pure encapsulations®, Sudbury, MA
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Was responsible for Quality Assurance dietary food supplements (GMPs are not approved; used Title 21 CFR § 100, 211, and 820). Prepared over 100 standard operating procedures for setup, operation, and cleaning of manufacturing equipment, receiving raw materials, sampling raw materials, shipping finished goods, warehouse operation of FIFO, calibration of equipment, etc. Prepared corporate SOP for customer complaint system. Prepared master and production/packaging batch record templates.
Quality Assurance Consultant, Sepracor, Inc., Marlborough, MA
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Provided expertise in Quality Assurance and Validation (Title 21 CFR § 58, 210, and 211). Performed cGMP audits at outsourced facilities (CMO's). Reviewed API master and executed manufacturing records (ICH Q7A Guidance); resolved analytical OOS reports. Reviewed executed manufacturing, packaging, and stability batch records from CMO's for clinical materials. Reviewed analytical results for release of: raw materials, packaging components, and finished product; resolved OOS/OOT reports. Reviewed executed commercial BFS manufacturing, packaging, statistical process control records; reviewed the associated analytical results and resolved any OOS. Reviewed process validation protocols, qualification protocols, and technology transfer documents for sterile facility. Reviewed validation summary and IQ/OQ/PQ summary reports. Worked with R&D to resolve process difficulties on a new controlled release product.
Manager, Quality and Scientific Affairs, SciVolutions™, Inc., Stoughton, MA
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Worked with the local and small business main district FDA to bring a series of Class I medical device products into the United States. Prepared and executed the finished product sterility validation. Prepared all quarterly gamma radiation protocols and samples for testing. Established the customer complaint procedure. Prepared Standard Operating Procedures (Title 21 CFR §820).
Manager, QA/QC, NutraMax Products, Inc., Cough and Cold Division, Brockton, MA
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Was responsible for total divisional quality affairs (Title 21 CFR §210 and 211). Quality team that directly interfaced with the FDA for all inspections as well as third party inspections. Responsible for maintaining a kosher facility; Interfaced directly with the Rabbi's for their quarterly inspections. Reviewed manufacturing and packaging batch records along with the SPC charts. Developed and implemented manager's quality awareness program. Developed and implemented compliance and customer complaint trending systems that alerted management to potential problem areas. Reviewed and approved manufacturing/packaging SPC charts, data, and production records for product release. Developed and implemented a cGMP training program for the packaging and production staff. Staffed and trained the quality control department in accordance with cGMP (Title 21 CFR §210 and 211) and GLP (non-clinical, Title 21 CFR §58). Implemented analytical method validation and reviewed summary reports. Prepared and implemented the divisional Out of Specification SOP in accordance with the FDA Guidance. Established all packaging component, raw material, and literature specifications.
ADDITIONAL EXPERIENCE
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Assistant Project Manager, (Astra, Westborough, MA), Vectech Pharmaceutical Consultants, Inc., Detroit, MI
Was responsible for the project leadership (commissioning of a newly constructed building, the qualification of a new aseptic process, and sterile filling operation-BFS) at a sterile pharmaceutical facility. Developed and prepared an International Product Technology Transfer Document. Prepared and executed installation (as per P&ID's) and operational qualifications for the WFI, process utilities (clean compressed air, nitrogen, clean steam, etc.), process equipment, etc.
Manager, Quality Assurance, Copley Pharmaceutical, Inc., Canton MA
Responsibilities included Validation, Technical Support and Documentation Control. One of two Quality Assurance managers that directly interfaced with the FDA for all inspections. Developed and implemented Copley's validation program. Developed and implemented the initial format and execution of 55 Annual Product Reviews. Validated a sterile BFS product at contract manufacturer. Prepared all master manufacturing and packaging batch records and statistical process control charts. Initiated and established the nonconformance and deviation report system. Initiated and managed the customer/product compliant system. Lectured at Massachusetts College of Pharmacy, graduate program, e.g., GMP, documentation control, master record writing, compliance issues, audits, etc. Coordinated the transition of prenatal vitamins from bottles to unit dose packaging.
R&D Formulation Chemist
Director, Quality Assurance, DuraMed Pharmaceutical, Inc., Cincinnati OH
(Directly interfaced with the FDA, QA inspection, Validation, Documentation Control, and Technical Services)
Manager of Manufacturing. Key Pharmaceutical, Inc., Miami FL
Total management responsibility for capsule/tablet production with a cost center of 98 employees and a budget of MM$7.0 to meet MM$125 sales.
Packaging Coordinating Supervisor, Lederle Laboratories, Pearl River NY
Assistant Department Head: Tablet Compression and Coating
Assistant Department Head: Soft Shell/Hard Shell Encapsulation
Department Head, Process Improvement/Technical Service Laboratory
Group Leader, Process Improvement/Technical Service Laboratory
Pharmaceutical Formulation Chemist, Process Improvement/Technical Service Laboratory
Pharmaceutical Formulation Scientist, Pfizer, Inc., Groton CT
Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.
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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax