due diligence, inspection, audits, assessments expert consultant resume
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Resume of LPH, Ph.D. Consultant
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  • Biotechnology
  • Chemical
  • FDA Regulated
  • Laboratory
  • Legal
  • Medical Device and Tissue Services
  • Pharmaceutical

The associated graduated with a Ph.D. in Physical Chemistry from Yale University.

The associate received a B.S. from City College of New York.

Due Diligence, Inspection, Audits, Assessments Expert Consultant Resume

This expert’s background includes FDA regulated industries, with emphasis in product development, quality assurance and control, auditing and validation, and manufacturing.

This associate offers expertise specific to pharmaceutical, biotechnology, and medical device and tissue services companies. This expert is highly experienced in matters related to GMP, GLP, GTP, and QSR. This associate is also experienced in quality system development, including master plans, risk assessment policies and procedures, and training programs.

This associate’s capabilities include inspection readiness, supplier quality and due diligence assessments, validation and product development programs, and document reviews. More specific examples of related expertise include advice to medical device manufacturers on technical aspects of due diligence, evaluations of potential acquisitions of business-related pharmaceutical products, quality system upgrade direction, and quality system policies and procedures for multi-site implementation specific to the biotechnology industry. Further examples include expert witness testimony in contract arbitration, quality and regulatory expertise conducting manufacturing site assessments specific to medical device manufacturers, implementation of new FDA drug guidance specific to pharmaceutical R & D, and compliance assessments of computerized laboratory systems.

Consultant, Kevin Kennedy Associates Inc.

Providing expertise in regulatory compliance and validation, quality assurance, due diligence and inspection readiness, audits and assessments, quality systems, forensic investigation and analysis, expert witness testimony, and related expertise to a wide variety of clients.

 

Vice President Corporate Quality, Purdue Pharma L.P. – Stamford, CT

Was responsible for QA, QC and auditing functions (GMP, GLP, GCP) throughout group of companies, including drug product and API manufacturing, supplier quality, drug development, clinical research and information systems. NDA and PAI related compliance activities and QA aspects of due diligence for acquisitions and licensing. SAP and QUMAS implementations.

 

Executive Director, Research Quality Assurance, Purdue Pharma L.P. – Stamford, CT

Reported to V.P. Corporate Quality, managed QA units for international R&D operations. Was responsible for GMP and GLP audits and systems development, pre-approval inspections, documentation and clinical supplies control, development of compliance policies and procedures for international product development and registration, and validation and training programs for R&D.

 

Director, R&D Quality Assurance, Boehringer Ingelheim Pharmaceuticals, Inc. – Ridgefield, CT

Established new regulatory compliance department for R&D unit, comprising GLP and GMP operations. Responsibilities included auditing, validation, supplier quality, training and inspection functions in support of international drug development. Coordinated pre-approval inspection activities for international registration projects.

 

Associate Director, Analytical Development, Boehringer Ingelheim Pharmaceuticals, Inc. – Ridgefield, CT

Provided management of comprehensive Analytical Method Development function for pre-clinical, clinical and registration applications, including drug substance and formulations. Provided coordination of IND, NDA and MAA submissions. Was head of R&D Quality Unit for control of clinical supplies.

 

Section Leader, Pharmaceutical Analysis, Boehringer Ingelheim Pharmaceuticals, Inc. – Ridgefield, CT

Was responsible for development, validation and application of drug product test methods in support of pharmaceutical development projects. Provided management of 3 test laboratories and information management. Provided stability evaluation of clinical supplies, providing data and methods for IND, NDA submissions.

 

Projects Manager/Group Leader, Analytical Services, American Cyanamid Company – Stamford, CT

Was responsible for spectroscopy, microscopy and surface analytical laboratories and pilot plant control. Provided analytical services for research programs, manufacturing sites and customers. Provided management of GMP test laboratory for bulk pharmaceutical intermediates.

 

Group Leader, Analytical and Process Development, American Cyanamid Company – Stamford, CT

Directed DOE contract to develop coal liquefaction catalysts. Was responsible for spectrophotometry, classical techniques and radio-chemistry. Developed analytical methods for specialty monomers, trace organic flocculants, polymer additives, synthetic sutures.

This expert has written numerous publications and presentations on topics related to chemical physics, organic analysis, coal liquefaction and upgrading of coal extracts, advanced database techniques, aerosol drug development, impurities in drug sub

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