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ENGINEERING AND SCIENTIFIC CONSULTING SERVICES
Resume of YRL, Ph.D.
Consultant
EXPERTISE AND SERVICES
Biochemist, Pharmaceutical Quality Assurance Consultant, Physical Organic Chemist, Validation Study Consultant, Regulatory Compliance Consultant, Specialist, Forensic Analysis Investigation Expert Witness Testimony, Consulting ServicesExpertise in quality control, pharmaceutical quality assurance and regulatory affairs, medical products businesses, chemistry, manufacturing and controls (CMC) section of drug master files, DMFs, analytical methods and process plans.
This KKAI Associate also specializes in form FDA 483 and warning letter responses, corrective and preventive action plans, training, general cGMP, general validation, and test method validation, negotiations with regulatory agencies, customers, distributors and internal group, data analysis including specification development and rationalization, and trend analysis.
Additional specialties include expiration and retest date justification, test method characterization and validation, site qualification processes, stem cell, and pancreatic islets processing, IVD product design validation documentation, test method validation document evaluation, data traceability audits, manufacturing process validation master plans, and new product development.
This associate has demonstrated specific expertise relative to planned discontinuance of out-dated products, NDA pre-approval inspections, corrective actions, responses and reinspection, chemical manufacturing processes, good manufacturing practice (cGMP), total quality management and ISO 9001 registration processes, in vitro diagnostic reagent and instrument design control and quality control
PRINCIPAL INDUSTRIES SERVED
Biochemical, Chemicals, Medical, Molecular Biology, Pharmaceutical, Pharmaceutical Manufacturing
EDUCATION
Ph.D., Physical Organic Chemistry, Northwestern University, Evanston, IL
B.S. (cum laude), Chemistry, Saint Norbert College, DePere, WI
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.
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Providing biochemistry related consulting, pharmaceutical quality assurance consulting, validation studies consulting, regulatory and GMP compliance consulting, forensic engineering and related expertise to a wide variety of clients.
Speak to this experienced, world-class expert now.
- Call (317) 735-7489
- E-mail yrl@rapid-response-consulting.com
For additional or different expertise, browse other top-level expert resumes from our broad offering of Expert Testimony, Failure Analysis, Manufacturing Optimization and a host of other Engineering and Scientific Consulting services.
Learn how KKAI assembles expert teams of any size or skill set combination to meet our clients' needs on a rapid-response basis - no matter how complex the challenge.
Or, peruse our 325 case studies or 475 other expert resumes.
Quality Assurance (QA) Director and Consultant
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Allergy IVD Systems, ISO 9001 Management Representative
Director, Quality Assurance , Bachem California, Torrance, CA
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Peptide API Manufacturer, Primary FDA Contact
Director, Quality Assurance & Regulatory Affairs, Peninsula Laboratories, Belmont, CA
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Peptide API Manufacturer, Biologics Responsible Head
Director, Quality Assurance , Ciba Corning/Biotrack, Mountain View, CA
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Blood Coagulation IVD Systems, Primary FDA Contact; TQM & ISO 9001
Director, Quality Assurance , Porton Diagnostics, Westlake Village, CA
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Blood Potassium IVD System, Primary FDA Contact; Wrote 510(k)
Director, Quality Assurance , Baxter/Dade Division, Miami, FL
Manager, Quality Assurance , Miles/Ames Division, South Bend & Elkhart, IN
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IVD Reagents & Analytical Methods Development
Manager, Quality Radioimmunoassay Business, Du Pont/New England Nuclear, North Billerica, MA
Manager, Analytical Laboratory Services Contract Testing Lab, Northview Laboratories, Northbrook, IL
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Primary FDA & Customer Contact
ADDITIONAL EXPERIENCE
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Negotiated manufacturing documentation in CMC section of three INDs, including site qualification processes, to assure consistency of stem cell, and pancreatic islets processing in two multi-center (3 to 10), Phase 3, NIH-sponsored clinical trials.
Upgrading Quality System of European subsidiary of US IVD company.
Led team that wrote major section of IVD Product Design Validation document
Evaluated over 200 test method validation documents
Trained over 300 people in test method validation
Advised materials control team on quality and regulatory compliance
Wrote CMC sections for 4 INDs.
Conducted numerous audits of API manufacturers, testing labs and suppliers.
Conducted numerous data traceability audits for finished drug stability studies.
Coordinated interactions of NDA team with API manufacturer
Wrote API manufacturing process validation master plans
Wrote manufacturing process validation protocols and final reports
Active member of 9 Project Teams, leading 3 of them, ranging from new product development to planned discontinuance of out-dated products.
Led an Active Pharmaceutical Ingredient manufacturer through its first NDA Pre-Approval Inspection (PAI) and subsequent corrective actions, responses and reinspection to gain FDA District approval recommendation for two NDAs.
Organized and documented the validation of API peptide chemical manufacturing processes. Reduced quality control turnaround time 40% by streamlining specifications and product disposition process.
Managed departments of 2 to 110 employees, the latter with a $7 million (1989) budget.
Designed quality and regulatory systems complying with current Good Manufacturing Practice (cGMP) regulations for two companies.
Kept an $8 million/year product on the market by negotiating with an FDA investigator and a distributor's QA and RA staffs during a recall and inspection. Received only one Observation on the FDA 483 after a 7-day inspection.
Wrote a successful pre-market notification, 510(k), for an in vitro diagnostic device.
Promoted the four-fold growth of a product line by: Anticipating and filling need for superior professional leadership in Quality Control. Balancing manufacturing efficiency and customer needs in negotiating a process to set expiration dates for reagents. Evaluating quality control and assurance personnel, facility, equipment and documentation requirements for expansion operations in Puerto Rico plant.
Initiated Total Quality Management and ISO 9001 Registration processes.
Wrote IVD Stability Study guidelines as member of Health Industry Manufacturer’s Association (HIMA) taskforce.
Led a team developing software control and validation requirements
GMP Compliance, including the Quality System Regulation for In Vitro Diagnostics and the Guidelines for Active Pharmaceutical Ingredients, Training, Auditing, Document Control, Biologics Responsible Head
In Vitro Diagnostic Reagent and Instrument Design Control and Quality Control
ISO 9001 Management Representative and Total Quality Management Implementer
Regulatory Submissions, Customer and Regulatory Communications.
Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.
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| Resume of BYT | biochemist, cgmp, glp, gcp, quality assurance, quality control consultant, regulatory compliance and validation consultant, forensic analysis investigation expert witness testimony, consulting services |
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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